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					                                 Request                           Submitter
  Status   Date of Submission               Submitter Name                         Submitter E-mail
                                  Code                             Affiliation

Closed     1/21/2009            18854      Tolk, Chris       CDISC               ctolk@cdisc.org

Closed     1/21/2009            18855      Tolk, Chris       CDISC               ctolk@cdisc.org




Closed     1/21/2009            18856      Tolk, Chris       CDISC               ctolk@cdisc.org

Closed     1/21/2009            18857      Tolk, Chris       CDISC               ctolk@cdisc.org




Closed     1/22/2009            18881      Tolk, Chris       CDISC               ctolk@cdisc.org




Closed     1/23/2009            18905      Mauron, Charlotte Hoffmann-La         charlotte.mauron@r
                                                             Roche               oche.com




Closed     1/23/2009            18906      Quinn, Theresa    NCI                 quinnt@mail.nih.gov




Closed     1/29/2009            19014      Muhlbradt, Erin   NCI-EVS             muhlbradtee@mail.n
                                                                                 ih.gov




Closed     1/29/2009            19016      Muhlbradt, Erin   NCI-EVS             muhlbradtee@mail.n
                                                                                 ih.gov




Closed     1/29/2009            19017      Muhlbradt, Erin   NCI-EVS             muhlbradtee@mail.n
                                                                                 ih.gov


Closed     1/29/2009            19018      Muhlbradt, Erin   NCI-EVS             muhlbradtee@mail.n
                                                                                 ih.gov

Closed     1/29/2009            19019      Muhlbradt, Erin   NCI-EVS             muhlbradtee@mail.n
                                                                                 ih.gov

Closed     1/29/2009            19021      Muhlbradt, Erin   NCI-EVS             muhlbradtee@mail.n
                                                                                 ih.gov
Closed   1/29/2009   19022   Muhlbradt, Erin   NCI-EVS       muhlbradtee@mail.n
                                                             ih.gov
Closed   1/29/2009   19023   Muhlbradt, Erin   NCI-EVS       muhlbradtee@mail.n
                                                             ih.gov

Closed   1/29/2009   19025   Muhlbradt, Erin   NCI-EVS       muhlbradtee@mail.n
                                                             ih.gov




Closed   1/29/2009   19026   Muhlbradt, Erin   NCI-EVS       muhlbradtee@mail.n
                                                             ih.gov
Closed   1/29/2009   19027   Muhlbradt, Erin   NCI-EVS       muhlbradtee@mail.n
                                                             ih.gov

Closed   2/3/2009    19115   Tolk, Chris       CDISC         ctolk@cdisc.org


Closed   2/3/2009    19116   Tolk, Chris       CDISC         ctolk@cdisc.org




Closed   2/3/2009    19120   Tolk, Chris       CDISC         ctolk@cdisc.org




Closed   2/3/2009    19122   Tolk, Chris       CDISC         ctolk@cdisc.org

Closed   2/3/2009    19123   Tolk, Chris       CDISC         ctolk@cdisc.org




Closed   2/3/2009    19124   Tolk, Chris       CDISC         ctolk@cdisc.org




Closed   2/3/2009    19125   Tolk, Chris       CDISC         ctolk@cdisc.org
Closed   2/4/2009    19140   Mattson, Monica   Celgene       mmattson@celgene.
                                               Corporation   com
Closed   2/12/2009         19374   Stoner, Gail      Johnson &        gstoner@its.jnj.com
                                                     Johnson




Closed   2/13/2009         19396   Austin, Randall   GlaxoSmithKline randall.r.austin@gsk
                                                                     .com




Closed   2/17/2009 19:24   19449   Tolk, Chris       CDISC            ctolk@cdisc.org


Closed   2/17/2009 19:29   19450   Tolk, Chris       CDISC            ctolk@cdisc.org

Closed   2/17/2009 19:31   19451   Tolk, Chris       CDISC            ctolk@cdisc.org


Closed   2/17/2009 19:33   19452   Tolk, Chris       CDISC            ctolk@cdisc.org
Closed   2/17/2009 19:37   19454   Tolk, Chris       CDISC            ctolk@cdisc.org

Closed   2/17/2009 19:48   19455   Tolk, Chris       CDISC            ctolk@cdisc.org

Closed   2/17/2009 19:56   19456   Tolk, Chris       CDISC            ctolk@cdisc.org

Closed   2/17/2009 19:58   19457   Tolk, Chris       CDISC            ctolk@cdisc.org

Closed   2/17/2009 20:00   19458   Muhlbradt, Erin   Lockheed Martin muhlbradtee@mail.n
                                                                     ih.gov
Closed   2/17/2009 20:04   19460   Tolk, Chris       CDISC          ctolk@cdisc.org

Closed   2/17/2009 20:17   19461   Tolk, Chris       CDISC          ctolk@cdisc.org


Closed   2/17/2009 21:25   19463   Tolk, Chris       CDISC          ctolk@cdisc.org


Closed   2/17/2009 21:35   19464   Tolk, Chris       CDISC          ctolk@cdsic.org




Closed   2/17/2009 21:38   19466   Tolk, Chris       CDISC          ctolk@cdisc.org

Closed   2/20/2009 8:27    19507   Quinn, Theresa    NCI            quinnt@mail.nih.gov




Closed   2/23/2009 10:40   19540   Muhlbradt, Erin   Lockheed Martin muhlbradtee@mail.n
                                                                     ih.gov


Closed   2/23/2009 11:03   19542   Muhlbradt, Erin   Lockheed Martin muhlbradtee@mail.n
                                                                     ih.gov

Closed   2/25/2009 8:01    19574   Tolk, Chris       CDISC          ctolk@cdisc.org




Closed   2/25/2009 8:04    19575   Tolk, Chris       CDISC          ctolk@cdisc.org

Closed   2/25/2009 8:08    19576   Tolk, Chris       CDISC          ctolk@cdisc.org

Closed   2/25/2009 8:11    19577   Tolk, Chris       CDISC          ctolk@cdisc.org


Closed   2/25/2009 8:16    19578   Tolk, Chris       CDISC          ctolk@cdisc.org


Closed   2/25/2009 8:19    19579   Tolk, Chris       CDISC          ctolk@cdisc.org


Closed   2/25/2009 8:21    19580   Tolk, Chris       CDISC          ctolk@cdisc.org

Closed   2/25/2009 8:23    19581   Tolk, Chris       CDISC          ctolk@cdisc.org

Closed   2/25/2009 8:26    19582   Tolk, Chris       CDISC          ctolk@cdisc.org


Closed   2/25/2009 8:29    19583   Tolk, Chris       CDISC          ctolk@cdisc.org
Closed   2/25/2009 8:35    19584   Tolk, Chris     CDISC          ctolk@cdisc.org




Closed   2/25/2009 8:37    19585   Tolk, Chris     CDISC          ctolk@cdisc.org




Closed   2/27/2009 10:26   19653   Gromen, Andreas Not Provided   andreas.gromen@b
                                                                  ayerhealthcare.com




Closed   2/27/2009 18:50   19678   Matejunas,      Shire          amatejunas@shire.c
                                   Armand                         om




Closed   2/27/2009 19:14   19679   Tolk, Chris     CDISC          ctolk@cdisc.org

Closed   2/27/2009 19:25   19681   Tolk, Chris     CDISC          ctolk@cdisc.org

Closed   2/27/2009 19:28   19682   Tolk, Chris     CDISC          ctolkl@cdisc.org

Closed   2/27/2009 19:30   19683   Tolk, Chris     CDISC          ctolk@cdisc.org

Closed   2/27/2009 19:32   19684   Tollk, Chris    CDISC          ctolk@cdisc.org


Closed   2/27/2009 19:35   19685   Tolk, Chris     CDISC          ctolk@cdisc.org

Closed   2/27/2009 19:38   19686   Tolk, Chris     CDISC          ctolk@cdisc.org


Closed   2/27/2009 19:41   19687   Tolk, Chris     CDISC          ctolk@cdisc.org
Closed   2/27/2009 19:47   19688   Tolk, Chris     CDISC          ctolk@cdisc.org


Closed   2/27/2009 19:49   19689   Tolk, Chris     CDISC          ctolk@cdisc.org
Closed   2/27/2009 19:52   19690   Tolk, Chris     CDISC          ctolk@cdisc.org

Closed   2/27/2009 19:55   19691   Tolk, Chris     CDISC          ctolk@cdisc.org


Closed   2/27/2009 19:59   19692   Tolk, Chris     CDISC          ctolk@cdisc.org
Closed   3/2/2009 10:43    19704   Lenzen, Mary       Octagon         mlenzen@octagonre
                                                      Research        search.com
                                                      Solutions




Closed   3/4/2009 12:39    19750   Muhlbradt, Erin    Lockheed Martin erin.e.muhlbradt@lm
                                                                      co.com




Closed   3/5/2009 9:18     19788   Muhlbradt, Erin    Lockheed Martin erin.e.muhlbradt@lm
                                                                      co.com
Closed   3/5/2009 13:59    19802   Muhlbradt, Erin    Lockheed Martin erin.e.muhlbradt@lm
                                                                      co.com




Closed   3/12/2009 8:54    19884   Nulton-Bodiford,   CDASH           liz.m.nulton-
                                   Liz                                bodiford@gsk.com


Closed   3/13/2009 10:28   19904   Muhlbradt, Erin    Lockheed Martin erin.e.muhlbradt@lm
                                                                      co.com

Closed   3/18/2009 17:59   20003   Mary Lenzen        Octagon         mlenzen@octagonre
                                                      Research        search.com
                                                      Solutions




Closed   3/18/2009 18:03   20004   Mary Lenzen        Octagon         mlenzen@octagonre
                                                      Research        search.com
                                                      Solutions
Closed   3/18/2009 18:07   20005   Mary Lenzen       Octagon          mlenzen@octagonre
                                                     Research         search.com
                                                     Solutions




Closed   3/24/2009 16:23   20131   Cheng, Yuan       ImClone System yuan.cheng@imclon
                                                                    e.com




Closed   4/6/2009 9:12     20469   Gromen, Andreas Bayer Schering     andreas.gromen@b
                                                   AG                 ayerschering.
                                                                      [incorrect e-mail for
                                                                      Andreas]




Closed   4/7/2009 16:12    20530   Austin, Randall   GlaxoSmithKline randall.r.austin@gsk
                                                                     .com
Closed   4/14/2009 13:24   20704   Facile, Rhonda    CDISC          rfacile@cdisc.org




Closed   4/14/2009 13:36   20706   Facile, Rhonda    CDISC          rfacile@cdisc.org




Closed   4/17/2009 14:52   20796   Muhlbradt, Erin   Lockheed Martin muhlbradtee@mail.n
                                                                     ih.gov


Closed   4/20/2009 14:30   20825   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions
Closed   4/20/2009 14:44   20828   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions
Closed   4/20/2009 14:48   20829   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions
Closed   4/20/2009 14:54   20830   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions


Closed   4/20/2009 15:00   20831   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions

Closed   4/20/2009 15:05   20832   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions

Closed   4/20/2009 15:09   20833   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions
Closed   4/20/2009 15:13   20835   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions

Closed   4/20/2009 15:16   20836   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions
Closed   4/20/2009 15:19   20837   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions

Closed   4/20/2009 15:22   20838   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions
Closed   4/20/2009 15:25   20839   Lenzen, Mary      Octagon        mlenzen@octagonre
                                                     Research       search.com
                                                     Solutions
Closed   4/20/2009 17:58   20856   Lenzen, Mary      Octagon           mlenzen@octagonre
                                                     Research          search.com
                                                     Solutions
Closed   4/20/2009 18:02   20857   Lenzen, Mary      Octagon           mlenzen@octagonre
                                                     Research          search.com
                                                     Solutions
Closed   4/20/2009 18:04   20858   Lenzen, Mary      Octagon           mlenzen@octagonre
                                                     Research          search.com
                                                     Solutions

Closed   4/20/2009 18:17   20859   Lenzen, Mary      Octagon           mlenzen@octagonre
                                                     Research          search.com
                                                     Solutions
Closed   4/20/2009 18:19   20860   Lenzen, Mary      Octagon           mlenzen@octagonre
                                                     Research          search.com
                                                     Solutions
Closed   4/23/2009 14:54   20908   Randall Austin    GlaxoSmithKline   randall.r.austin@gsk
                                                                       .com




closed   4/27/2009 1:17    20930   Mauron, Charlotte Hoffmann-La       charlotte.mauron@r
                                                     Roche             oche.com




closed   4/28/2009 9:13    20964   Quinn, theresa    NCI/EVS           tquinn@charterinter
                                                                       net.com
closed   4/28/2009 9:17    20965   Quinn, Theresa    NCI/EVS           tquinn@charterinter
                                                                       net.com


closed   4/28/2009 9:19    20966   quinn, theresa    NCI/EVS           tquinn@charterinter
                                                                       net.com

closed   4/28/2009 9:21    20967   quinn, theresa    NI/EVS            tquinn@charteintern
                                                                       et.con
closed   4/28/2009 9:24    20968   quinnt, theresa   NCI/EVS           tquinn@charterinter
                                                                       net.com
closed   4/28/2009 9:26    20969   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 9:29    20970   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 9:30    20971   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 9:32    20972   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 9:35    20973   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 9:37    20974   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 9:38    20975   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 10:07   20977   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 10:11   20978   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 10:20   20980   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 10:21   20981   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 10:24   20982   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   4/28/2009 10:58   20985   quinn, theresa   NCI/EVS          tquinn@charterinter
                                                                     net.com
closed   5/19/2009 3:34    21352   Pemble, Nik      J&J          npemble@its.jnj.com




closed   5/19/2009 3:45    21353   Pemble, Nik      J&J          npemble@its.jnj.com




closed   5/20/2009 13:56   21398   ONeill, Debra    Merck            debra_oneill@merck
                                                                     .com




closed   5/21/2009 10:38   21416   Vaughn, Carol    sanofi-aventis   Carol.Vaughn@sano
                                                                     fi-aventis.com




Closed   6/3/2009 8:19     21561   Wientges, Jens   IBM              wientges@de.ibm.co
                                                                     m
Closed   6/3/2009 8:32     21562   Wientges, Jens   IBM Deutschland wientges@de.ibm.co
                                                    GmbH            m


Closed   6/16/2009 12:14   21778   Dong, Fugui      Pharmanet      fdong@pharmanet.c
                                                                   om




Closed   6/16/2009 12:14   21778   Dong, Fugui      Pharmanet      fdong@pharmanet.c
                                                                   om




Closed   6/17/2009 12:54   21813   Tolk, Chris      CDISC          ctolk@cdisc.org




Closed   6/19/2009 12:06   21869   Dong, Fugui      Pharmanet      fdong@pharmanet.c
                                                                   om
Closed   6/30/2009 14:37   22086   Dong, Fugui      Pharmanet      fdong@pharmanet.c
                                                                   om




Closed   6/30/2009 14:42   22087   Dong, Fugui      Pharmanet      fdong@pharmanet.c
                                                                   om
Closed   7/6/2009 8:23     22116   Wientges, Jens   IBM              wientges@de.ibm.co
                                                                     m




Closed   7/10/2009 10:38   22280   Vaughn, Carol    Sanofi-Aventis   Carol.Vaughn@sano
                                                                     fi-aventis.com




Closed   7/13/2009 2:06    22292   Gromen           Bayer Schering   andreas.gromen@b
                                                    Pharma           ayerhealthcare.com




Closed   7/15/2009 6:01    22324   Haglund, Tore    AstraZeneca      tore.haglund@astraz
                                                                     eneca.com
Closed   7/16/2009 10:21   22356   Lenzen, Mary     Octagon          mlenzen@octagonre
                                                    Research         search.com
                                                    Solutions
Closed   7/16/2009 10:24   22357   Lenzen, Mary     Octagon          mlenzen@octagonre
                                                    Research         search.com
                                                    Solutions




Closed   7/16/2009 12:03   22359   Lenzen, Mary     Octagon          mlenzen@octagonre
                                                    Research         search.com
                                                    Solutions


Closed   7/16/2009 12:04   22360   Lenzen, Mary     Octagon          mlenzen@octagonre
                                                    Research         search.com
                                                    Solutions


Closed   7/16/2009 12:08   22361   Lenzen, Mary     Octagon          mlenzen@octagonre
                                                    Research         search.com
                                                    Solutions




Closed   7/16/2009 12:09   22362   Lenzen, Mary     Octagon          mlenzen@octagonre
                                                    Research         search.com
                                                    Solutions




Closed   7/23/2009 12:15   22464   SRIVASTAVA,      Booz-Allen-      srivastava_ranjana
                                   RANJANA          Hamilton         @bah.com




Closed   7/23/2009 14:50   22485   Randall Austin   GlaxoSmithKline randall.r.austin@gsk
                                                                    .com
Closed   7/30/2009 10:21   22628   Pallas, MIchelle   Genentech        michelcp@gene.co
                                                                       m




Closed   7/30/2009 10:26   22629   Pallas, Michelle   Genentech        michelcp@gene.co
                                                                       m




Closed   7/30/2009 12:40   22642   Wientges, Jens     IBM Deutschland wientges@de.ibm.co
                                                      GmbH            m




Closed   8/6/2009 19:12    22775   Omundsen, Erica    CDISC Corporate eomundsen@fibroge
                                                      Member          n.com




Closed   8/21/2009 19:59   22970   Ramage, David      Daiichi Sankyo   dramage@dsi.com
Closed   10/12/2009 16:37   23782     Ort, Jack           ResearchPoint     jort@researchpoint.c
                                                                            om




Closed   11/16/2009 10:26   24313     Van-Keer, Marie-    sanofie-aventis   marie-rose.van-
                                      rose                                  keer@sanofi-
                                                                            aventis.com




Closed   12/8/2009 13:02    24744     quinn, theresa      NCI EVS           quinnt@mail.nih.gov




Closed   12/9/2009 12:51    24798     ONeill, Debra       Merck             debra_oneill@merck
                                                                            .com




Closed   12/9/2009 12:53    24799     ONeill, Debra       Merck             debra_oneill@merck
                                                                            .com
Closed   12/9/2009 12:55    24800     ONeill, Debra       Merck             debra_oneill@merck
                                                                            .com
Closed   12/23/2009 14:59   25174     Muhlbradt, Erin     LMCO              erin.e.muhlbradt@lm
                                                                            co.com

Open     12/23/2009 15:57   25190     Harrington, Brian   ERT (eResearch bharrington@ert.co
                                                          Technology)    m




closed   5/19/2009 3:41     Comment   Tolk, Chris         CDISC             ctolk@cdisc.org
                            on item
                                                             New Term or Codelist/Existing
  Submitter Phone        Request Type       CDISC Codelist
                                                                Term or Code Number

203-220-9345        Modify Existing Term   SDTM-LBTEST       Codelist C67154

203-220-9346        Modify Existing Term   SDTM-LBTEST       C 35266 - Anisocytois




203-220-9347        Modify Existing Term   SDTM-LBTESTCD     HYPO

203-220-9348        Modify Existing Term   SDTM-VSTESTCD     For LBTEST and LBTESTCD -
                                                             May-Hegglin Anomaly




203-220-9349        Modify Existing Term   SDTM-LBTEST       ALT




41-61-688 9316      Modify Existing Term   SDTM-UNIT         C42570, C68858 in codelist
                                                             C71620




757-238-3582        Modify Existing Term   SDTM-LBTEST,      Pokilocytosis
                                           SDTM-LBTESTCD




703 891 6415        Modify Existing Term   SDTM-TPHASE       C49686 Phase IIa Trial




704 891 6415        Modify Existing Term   SDTM-TPHASE       C49688 Phase IIb Trial




705 891 6415        Modify Existing Term   SDTM-SOC          C49399 CONGENITAL,
                                                             FAMILIAL AND GENETIC
                                                             DISORDERS

706 891 6415        Modify Existing Term   SDTM-DICTNAM      C49476 LOINC


707 891 6415        Modify Existing Term   SDTM-LBTEST       C74610 Dohle Bodies


708 891 6415        Modify Existing Term   SDTM-EGTESTCD NOTCHED T-WAVES
709 891 6415   Modify Existing Term   SDTM-EGTEST     BIFASICULAR BLOCK

710 891 6415   Modify Existing Term   SDTM-EGTEST     ATRIAL FLUTTER


711 891 6415   Modify Existing Term   SDTM-UNIT       C44277 Degree Fahrenheit (F)




712 891 6415   Modify Existing Term   SDTM-MARISTAT   DIVORCED

713 891 6415   Modify Existing Term   SDTM-UNIT       C42546 Newton


203-220-9345   Modify Existing Term   SDTM-LBTEST     C74688


203-220-9345   Modify Existing Term   SDTM-LBTEST     C64470




203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C64471




203-220-9345   Modify Existing Term   SDTM-LBTESTCD   AST

203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C64487




203-220-9345   Modify Existing Term   SDTM-LBTEST     C74753




203-220-9345   Modify Existing Term   SDTM-LBTEST     C61032
Not given      Create New Term        SDTM-AESEV      Two new terms: LIFE-
                                                      THREATENING and FATAL
610-889-4652   Create New Term        SDTM-NCOMPLT    SUBJECT REFUSED STUDY
                                                      TREATMENT




919.483.1379   Modify Existing Term   SDTM-STENRF     C66728 - add term
                                                      BEFORE/DURING




203-220-9345   Modify Existing Term   SDTM-LBTEST     C64549


203-220-9345   Modify Existing Term   SDTM-LBTEST     C64550

203-220-9345   Modify Existing Term   SDTM-LBTEST     C64604


203-220-9345   Modify Existing Term   SDTM-LBTEST     C74782
203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C74676

203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C64847

203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C64851

203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C74739

703 891-6415   Modify Existing Term   SDTM-FRM        C42956, C42945, C42899,
                                                      C42995, C42926, C42951
203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C64818

203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C64919


203-220-9345   Modify Existing Term   SDTM-LBTEST     C64820


203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C74654




203-220-9345   Modify Existing Term   SDTM-LBTESTCD   C64821

757-238-3582   Other                  None            Life Threatening




703 891-6415   Modify Existing Term   SDTM-COUNTRY    C17095 Reunion




703 891-6415   Modify Existing Term   SDTM-COUNTRY    C16334 Bermuda


203-220-9345   Modify Existing Term   SDTM-LBTEST     Ery. Mean Corpuscluar HB
                                                      Concentration C64798


203-220-9345   Modify Existing Term   SDTM-LBTEST     Modify definition text for
                                                      Microcytes
203-220-9345   Modify Existing Term   SDTM-LBTESTCD   Monocytes/C64823

203-220-9345   Modify Existing Term   SDTM-LBTEST     Monocytes/Leukocytes /C64824


203-220-9345   Modify Existing Term   SDTM-LBTESTCD   Myeloblasts/Leukocytes /
                                                      C74646

203-220-9345   Modify Existing Term   SDTM-LBTEST     Myelocytes/Leukocytes
                                                      /C64826

203-220-9345   Modify Existing Term   SDTM-LBTEST     Neutrophils

203-220-9345   Modify Existing Term   SDTM-LBTEST     Neutrophils Band Form /
                                                      C64830
203-220-9345   Modify Existing Term   SDTM-LBTEST     Neutrophils Band
                                                      Form/Leukocytes / C64831

203-220-9345   Modify Existing Term   SDTM-LBTEST     Neutrophils/Leukocytes /
                                                      C64827
203-220-9345       Modify Existing Term   SDTM-LBTEST     Pelger Huet Anomaly / C74617




203-220-9345       Modify Existing Term   SDTM-LBTEST     Phosphate /C64857




+49 30 468 17071   Modify Existing Term   SDTM-NCOMPLT    C48227




484-595-8324       Modify Existing Term   SDTM-AESEV      Severe term / C41340




203-220-9345       Modify Existing Term   SDTM-LBTEST     Platelets / C51951

203-220-9345       Modify Existing Term   SDTM-LBTESTCD   Poikilocytes/Erythrocytes /
                                                          C74649
203-220-9345       Modify Existing Term   SDTM-LBTESTCD   RBC /C51946

203-220-9345       Modify Existing Term   SDTM-LBTESTCD   RBCNUC / C74705

203-220-9345       Modify Existing Term   SDTM-LBTESTCD   Nucleated
                                                          Erythrocytes/Erythrocytes /
                                                          C74647
203-220-9345       Modify Existing Term   SDTM-LBTEST     Reticulocytes / C51947

203-220-9345       Modify Existing Term   SDTM-LBTEST     Reticulocytes/Erythrocytes
                                                          /C64828

203-220-9345       Modify Existing Term   SDTM-LBTEST     Thyroxine, Free /C74786
203-220-9345       Modify Existing Term   SDTM-LBTESTCD   Dacryocytes /C64801


203-220-9345       Modify Existing Term   SDTM-LBTEST     Urate /C64814
203-220-9345       Modify Existing Term   SDTM-LBTESTCD   WBC /C51948

203-220-9345       Modify Existing Term   SDTM-LBTEST     Prolymphocytes/Leukocytes
                                                          /C64829

203-220-9345       Modify Existing Term   SDTM-LBTESTCD   Lymphocytes /C51949
401-364-7402   Other                  SDTM-NCOMPLT    Not completed




703 891 6415   Modify Existing Term   SDTM-LBTESTCD   C74792, C75386 Somatotropin
                                                      and Growth Hormone
                                                      Measurement




703 891 6415   Modify Existing Term   SDTM-LBTESTCD   C74634 Bite Cells/Erythrocytes

703 891 6415   Modify Existing Term   SDTM-LBTEST     C74761, C74894, C74753




Not given      Modify Existing Term   SDTM-FRM        C42966, C42993, C42887,
                                                      C42994


703 891 6415   Modify Existing Term   SDTM-LBTEST     CDISC PT Folic Acid


401-364-7402   Modify Existing Term   SDTM-ETHNIC     C66790




401-364-7403   Modify Existing Term   SDTM-TPHASE     C49687
401-364-7404        Modify Existing Term   All             All




646-638-5043        Create New Term        SDTM-LBTEST     Indican




+49 30 468 170071   Modify Existing Term   SDTM-LBTEST     C74616




919.483.1379        Modify Existing Term   SDTM-LBTESTCD   C67154
5122639529     Create New Term        SDTM-UNIT        PACK YEARS




5122639530     Create New Term        SDTM-UNIT        QD




703 891-6415   Modify Existing Term   SDTM-LBTEST      C74768




484-881-2295   Modify Existing Term   SDTM-ETHNIC      C66790 - Patient Ethnic Group


484-881-2295   Create New Term        SDTM-DOMAIN      Domain - C66734


484-881-2295   Create New Term        SDTM-DOMAIN      Domain - C66734


484-881-2295   Modify Existing Term   SDTM-DOMAIN      Correct term C49566 for BM
                                                       code in Domain (C66734 )
                                                       codelist


484-881-2295   Other                  SDTM-TSPARMCD Delete term AEDICT ( C49700)
                                                    in TSPARMCD (C66738)
                                                    codelist

484-881-2295   Other                  None             Delete term Adverse Event
                                                       Dictionary (C49700)


484-881-2295   Other                  SDTM-TSPARMCD DRUGDICT (C49701) in
                                                    TSPARMCD (C66738) codelist

484-881-2295   Other                  SDTM-TSPARM      Delete term Drug Dictionary
                                                       (C49701) in TSPARM(C67152)
                                                       codelist

484-881-2295   Other                  SDTM-TSPARMCD MHDICT (CC49702) in
                                                    TSPARMCD (C66738)

484-881-2295   Other                  SDTM-TSPARM      Medical Dictionary (C49702) in
                                                       TSPARM(C67152)


484-881-2295   Create New Term        SDTM-TSPARMCD TSPARMCD (C66738)


484-881-2295   Create New Term        SDTM-TSPARM      TSPARM (C67152)
484-881-2295    Create New Term        SDTM-TSPARM     new term OBJSEC to the
                                                       TSPARM C67152) codelist

484-881-2295    Create New Term        SDTM-TSPARMCD new term OBJSEC to the
                                                     TSPARMCD (C66738)

484-881-2295    Create New Term        SDTM-TSPARM     new term "Trial
                                                       Secondary Objective" to
                                                       the TSPARM C67152)

484-881-2295    Create New Term        SDTM-TSPARMCD TSPARMCD (C66738) codelist


484-881-2295    Create New Term        SDTM-TSPARM   new term "Sponsoring
                                                     Organization" to the
                                                     TSPARM (C67152)
919.483.1379    Create New Term        SDTM-EGSTRESC none




41-61-6889316   Other                  SDTM-POSITION   C62174




757 238-3582    Modify Existing Term   Not provided    C49641

758 238-3582    Modify Existing Term   Not provided    C28233




759 238-3582    Modify Existing Term   Not provided    C33507


760 238-3582    Modify Existing Term   Not provided    C34786

761 238-3582    Modify Existing Term   Not provided    C38235
762 238-3582     Modify Existing Term   Not provided    C72554

763 238-3582     Modify Existing Term   Not provided    C42555

764 238-3582     Modify Existing Term   Not provided    C42554

765 238-3582     Modify Existing Term   Not provided    C42558

766 238-3582     Modify Existing Term   Not provided    C44277

767 238-3582     Modify Existing Term   Not provided    C49641

768 238-3582     Modify Existing Term   Not provided    C54711

769 238-3582     Modify Existing Term   Not provided    C68915

770 238-3582     Modify Existing Term   Not provided    C70511,C70512,C70513,
                                                        c71168
771 238-3582     Modify Existing Term   Not provided    C71061

772 238-3582     Modify Existing Term   Not provided    C71089

773 238-3582     Modify Existing Term   Not provided    C71325

774 238-3582     Modify Existing Term   Not provided    C74700

                 Modify Existing Term   SDTM-LBTESTCD   FGRANCS - change to
                                                        CSFGRAN


                 Modify Existing Term   SDTM-LBTESTCD   LACTICAC




267-305-8124     Create New Term        SDTM-LBTEST     Protein 24 Hr




908-304-6298     Create New Term        SDTM-ACN        DOSE DELAYED




49 160 5826897   Modify Existing Term   SDTM-UNIT       C70526
50 160 5826897   Modify Existing Term   SDTM-UNIT     Code C70527 of Codelist
                                                      C71620


609-951-6941     Create New Term        SDTM-LBTEST   Fragment D-dimer




609-951-6941     Create New Term        SDTM-LBTEST   Fragment D-dimer




203-220-9345     Modify Existing Term   SDTM-UNIT     for the all terms in the unit code
                                                      list add synonym with mcg for u




609-951-6941     Create New Term        SDTM-VSTEST   Knee to Heel Length

609-951-6941     Create New Term        SDTM-LBTEST   Partial pressure of carbon
                                                      dioxide




609-951-6941     Create New Term        SDTM-LBTEST   Oxygen, partial pressure
49 160 5826897     Other             SDTM-COUNTRY     C66786 / COUNTRY




908-304-6298       Create New Term   SDTM-TOXGR




+49 30 468 17071   Create New Term   SDTM-UNIT        U/L




Not given          Create New Term   SDTM-VSTEST   SAD - Sagittal Abdominal
                                                   Diameter
484-881-2295       Create New Term   SDTM-TSPARMCD EXISTRT
484-881-2295   Create New Term        SDTM-TSPARM    Existing Treatment (TSPARM)
                                                     for EXISTRT (TSPARMCD)




484-881-2295   None                   SDTM-TSPARMCD New TSPARMCD = TRT for
                                                    "Name of
                                                    Treatment"


484-881-2295   None                   SDTM-TSPARM    Add TSPARM (Name of
                                                     Treatment)




484-881-2295   None                   SDTM-TSPARMCD New Term TSPARMCD = OBJ




484-881-2295   None                   SDTM-TSPARM    New Term TSPARM =
                                                     OBJECTIVE




301-838-3813   Modify Existing Term   SDTM-TOXGR     New Term: Grade 0 Adverse
                                                     Event; C66784, C66784,
                                                     C66784, C66784, C66784




919.483.1379   Modify Existing Term   SDTM-STENRF    STENRF
650-225-2676     Create New Term        SDTM-ACN        MULTIPLE




650-225-2676     Create New Term        SDTM-ACN        INFUSION




50 160 5826897   Modify Existing Term   None            LBTESTCD, C65047




415-978-1351     Create New Term        SDTM-LBTESTCD   New Term needed for Total
                                                        Bilirubin




732-590-4943     Modify Existing Term   SDTM-EVAL       C78735
                    Create New Term        SDTM-FREQ       Every a.m. / Every p.m.




33-01-55-71-28-41   Create New Term        SDTM-OUT        Add Not Recovered/Stabilized




                    Modify Existing Term   SDTM-LOC        C32996




267-305-8124        Create New Term        SDTM-LBTEST     Cortisol, Free




267-305-8124        Create New Term        SDTM-LBTESTCD   CORTISLF

267-305-8124        Modify Existing Term   SDTM-LBTEST     Cortisol

                    Modify Existing Term   SDTM-UNIT       mL


215-282-5565        Create New Term        EGSTRESC        Other




203-220-9345        Modify Existing Term   SDTM-LBTESTCD   HYPO
                         Justification                                            Summary

To be consistent with other "Ratio" terms.     Remove "Ratio" from Albumin/Creatinine Ratio.

Use the cell name rather than the diagnosis.             Change Anisocytosis to Anisocytes




HYPO is not specific enough.                             Change HYPO to HYPOCROM

The definition is not specific enough. Need to add the   For LBTEST and LBTESTCD - May-Hegglin Anomaly
additional text.




Add synonym                                              Add SGPT as a synonym.




This is a topic we had discussed ealier and decided to    2 different concepts with same PT (m3)
wait until this change process was implemented. The
terms C42570 and C68858 have the same CDISC PT of
m3. From the definitions provided, they seem to represent
different concepts.

Modification                                             Remap Pokilocytosis to Pokilocyte Measurement




Misspelling in definition.                               The word 'Refered' spelled wrong - Should be 'referred'




Misspelling in definition.                               Misspelling in definition of Phase IIb Trial - Refered
                                                         change to Referred




Misspelling in definition                                Characteristic is misspelled in def




Double 'the' in definition.                              Take one 'the' in definition of LOINC


Misspelling in definition.                               Change bodie to body in definition


Misspelling in definition                                Change 'occuring' to 'occurring' in definition
Misspelling in definition                                   Change 'occuring' to 'occurring' in def

Grammar in definition.                                      Add word 'is' between 'generally' and 'at' in def.


Double (NCI) in def.                                        Remove (NCI) from end of CDISC definition.




Misspelling in definition                                   Marriage is spelled wrong in the definition

Stylistic inconsistency in definition.                      Change meter/sec(2) to meter/sec2 in definition.


The term should be Barbiturates instead of Barbiturate      Make the term Barbituates
because we are measuring the drug class. This is
consistant with other drug classes.
To be consistent with other definitions change A count of   Change definition to A measurement of of the basophils
the basophils per unit of a biological specimen to A        per unit of a biological specimen.
measurement of of the basophils per unit of a biological
specimen.
Change text from measure to measurement to be               Change for measure to measurement
consistent and use ther word measurement for all terms


Add synonym of SGOT                                         Add synonym of SGOT

Change the text from measure to measurement. New text: Change measure to measurement.
A relative measurement (ratio or percentage) of the blasts
to leukocytes in a biological specimen. All should have
the word measurement to be consistent.

The CDSIC submission value should be without the word Remove the word Ratio from CDISC submission value
ratio. New text:BUN/Creatinine. There are only a couple
of values that have the word ratio. THis will make all of
the ratio terms consistent.
Add Total Cholesterol as a synonym.                         Add Total Cholesterol as a synonym.
Need more granularity in the differentiation of severity of AESEV new terms
AEs
Many of our study designs have an extended period of        Add "SUBJECT REFUSED STUDY TREATMENT" to
post-treatment follow up (3-6 months) that includes both SDTM-NCOMPLT codelist
efficacy and safety assessments. If a subject
discontinues study drug prematurely, most protocols
require that they still complete the full follow-up period.
For this reason, we collect and report on disposition for
the treatment phase of the study separately from the
follow up phase. We have situations where the subject
refuses further study drug, but is willing to stay in the
study and complete the follow up period. Oncology
colleagues have indicated that this is not uncommon and
they wish to include this reason on the CRF for use in
summary tables. None of the existing REAS terms seems
appropriate. We specifically do not want to use
"Withdrawal by subject" because that is widely
interpreted as meaning the subject refuses
participation/data collection of any kind.



Codelist is not extensible but does not cover all scenarios Add BEFORE/DURING term to STENRF codelist




Correct text to match other terms.                        Modify definition to A measurement of the elliptically
                                                          shaped erythrocytes in a biological specimen. Add
                                                          synonym Ovalocytes.
Consistwncy with other definitions.                       Modify definition

Consistency in definitions.                               Modify definition.


Add synonym.                                                Add synonym.
All of the other vitamins are referred to by VIT. Change to Change term to VITB9
be consistent.
Error in definition.                                        Change from transpeptidase to tranferase

Add synonym for HCG                                       Add synonym for HCG

Add synonym Glutamic Acid.                                Add synonym Glutamic Acid.

The values in column E should equal the values in         Please make the Submission Value equal to PT on row
column F in this codelist.                                407-412 of published spreadsheet
Consistency with other definitions                         Modfiy definition for Lymphocytes Atypical

Consistent definition.                                     Change measure to measurement


Consistency of definition                                  Change measure to measurement for LYMLE


Definition consistency                                     Change definition




Consistent definition                                      Modify definition for Macrocytes

Life Threatening is listed as a CDISC PT; however, it is Life Threatening is not a part of any codelist
not actually a part of any codelist. 4 is the PT for the
SDTM-TOXGR. I suggest either changing the designation
of Life Threatening to a SY or adding it to a codelist.




The definition is incorrect, gramatically.                 Minor change to definition for Reunion, the country.




Bermuda requires a definition.                             No definition on CT spreadsheet for Bermuda


Change Ery. Mean Corpuscluar HB Concentration to Ery. Change Ery. Mean Corpuscluar HB Concentration to
Mean Corpuscluar HGB Concentration to add the B in HB Ery. Mean Corpuscluar HGB Concentration
for consistency in the abbreviation of hemaglobin.

Consistency in text.                                       New text should read: A measurement of the microcytes
                                                           per unit of a biological specimen.
Consistent definition.                                     New text should read: A measurement of the monocytes
                                                           per unit of a biological specimen.
Change to make definition consistent with other terms.     New text should be: A relative measurement (ratio or
                                                           percentage) of the monocytes to leukocytes in a
                                                           biological specimen.
Text change for consistency.                               New text should be: A relative measurement (ratio or
                                                           percentage) of the myeloblasts to leukocytes in a
                                                           biological specimen.
Consistent text in definition.                             New text should be: A relative measurement (ratio or
                                                           percentage) of the myelocytes to leukocytes in a
                                                           biological specimen.
Consistent definition.                                     New text: A measurement of the neutrophils per unit of a
                                                           biological specimen.
Consistent text                                            New text: A measurement of the banded neutrophils per
                                                           unit of a biological specimen.
Consistent Text                                            New test: A relative measurement (ratio or percentage)
                                                           of the banded neutrophils to leukocytes in a biological
                                                           specimen.
Text consistency                                           New test: A relative measurement (ratio or percentage)
                                                           of the neutrophils to leukocytes in a biological specimen.
Better understanding                                          New text: A measurement of the Pelger Huet Anomaly
                                                              (neutrophils and eosinophils nuclei appear rodlike,
                                                              spherical or dumbbell shapped) in a biological specimen.




Add synonym                                                   Add synonym: Phosphorus




A clarification is needed if this is the CDISC indented       Lost to follow-up defintion change request
definition or if this will be changed, because the exact
same term has been used in my organization with a
different definition.



Shire's physicians rationale and support of their position:   Modify definiton of severe in AESEV codelist
We believe the CDISC definition itself is 'too severe' and
the definition overlaps a lot with Serious AE. From our
perspective, there needs to be a more clear distinction.




Consistent definition                                         New definition: A measurement of the platelets in a
                                                              biological specimen.
Correct error, remove )                                       Correct error, remove ) in definition

Add synonym and modify definition for consistency.            Add Red Blood Cells as synonym and change definition
                                                              as below.
Add synonym for RBCNUC                                        Add synonym: Nucleated Red Blood Cells

Add synonym for Nucleated Erythrocytes/Erythrocytes           Synonym is: Nucleated Red Blood Cells/Erythrocytes


Consistent text definition                                    New text: A measurement of the reticulocytes per unit of
                                                              a biological specimen.
Consistent documentation of definition                        New text: A relative measurement (ratio or percentage)
                                                              of reticulocytes to erythrocytes in a biological specimen.

Correct spelling error                                        New term: Thyroxine, Free
Change definition to be consistent with other terms and       New synonym: Tear Shaped Erythrocytes. New
add synonym.                                                  definition: A measurement of dacryocytes per unit of a
                                                              biological specimen.
Add synonym                                                   New synonym: Uric Acid
Add synonym: White Blood Cells                                Add synonym: White Blood Cells

Change definition for consistency                             New text: A relative measurement (ratio or percentage)
                                                              of prolymphocytes to leukocytes in a biological
                                                              specimen.
Consistent definition                                         New text: A measurement of the lymphocytes per unit of
                                                              a biological specimen.
Change definition of NCOMPLT codlist (C66727) to               Change definition of NCOMPLT codlist (C66727)
"If the subject completed the study or segment of
the study (e.g. Treatment if data is collected at that
granularity) then the term will be
"COMPLETED". If the subject does not
complete the study or segment of the study then this is
the reason that a subject discontinued." Current
definition of "The reason that a subject was
discontinued from a clinical trial." does not
encompass the fact that the subject could complete a
portion of the trial. Current defintion is not consistent with
CDISC SDTMIG (Study Data Tabulation Implementation
Guide).


C74792, C75386 are potential synonyms. Technically,         C74792, C75386 are potential synonyms in LBTEST and
Somatotrophin and Growth Hormone are analogous; both LBTESTCD codelists
are names for the 191kDa hormone that is produced by
somatotroph cells in the anterior pituitary gland (other
synonyms also include HGH, Human Growth Hormone).
The term somatotropin (without the h) is an analogous
term that indicates the recombinant form of
Somatotrophin, or a structurally and functionally identical
hormone that is produced by bacterial expression
systems for clinical use.




C74634 Bite Cells/Erythrocytes appears twice in LBTEST C74634 Bite Cells/Erythrocytes appears twice in
and LBTESTCD codelist.                                      LBTEST and LBTESTCD codelist
All other terms of this type do not contain the word ratio. Consistency issues in CDISC PT
For consistency CDISC may want to consider removing
the word ratio from the PT.




These abbreviations will be how these terms are recorded Add synonyms to align CDASH IG appendix A with
on the CRF by site personnel. Addition of these          SDTM fully
synonyms will align CDASH IG appendix A with SDTM
fully.
See request 19454                                        Change CDISC PT Folic Acid to Vitamin B9


Change name of codelist from "Patient Ethnic          Change name of codelist from "Patient Ethnic Group" to
Group" to "Ethnic Group". 1)codelist is     "Ethnic Group"
not limited to patients. 2) Not consistent with other
codelist names - "Race" is called
"Race" and not "Subject Race".

Typo in term "Phase IIIaTrial" needs to be       Typo in term "Phase IIIaTrial" needs to be corrected to
corrected to "Phase IIIa Trial". Space is        "Phase IIIa Trial". Space is missing.
missing.
Change "CDISC Code List" drop down list in Change "CDISC Code List" drop down list
this form to 1) remove "SDTM" from each
codelist name since these codelists are not just
applicable for SDTM so it's very confusing and misleading
2) please sort codelist alphabetically - order in dropdown
list seems to be random and it's difficult to find a codelist
without searching through the whole list.




Urine Indican Test, also known as Obermeyer test, is one indican test
type of Urine Metabolism Tests. This test serves as an
indication of protein Metabolism status in digest duct and
it is used in clinical trial.




Clarify defintion, because it is unclear                 Pappenheimer Bodies and Siderocytes




Correct typos, remove duplicates                         3 lab test entries may have issues (typo, duplicates)
Pack year is a commonly term used to describe the         Pack Years = Pack year is a term used to describe the
amount a person has smoked over time. One pack year is    amount a person has smoked over time. One pack year
defined as 20 manufactured cigarettes (1 pack) smoked     is defined as 20 manufactured cigarettes (1 pack)
per day for one year.                                     smoked per day for one year.




The CDASH project team requests that QD be added the Add QD to the terminology code lists
terminology codelists to mean every day. The closest
term is "Q24 hr", however, QD is commonly used by
clinicians in medical charts and on case report forms.

Misspelling in definition - Change 'course' to 'coarse'   Mispelling in definition of C74768




Name of this codelist should be changed to Subject       Change name of codelist to Subject Ethnic Group
Ethnic Group as per page 272 of the SDTMIGv3.1.2 - row
1 in the table.
Add new term for CE - Clinical Events to Domain codelist Add Clinical Events to Domain codelist.
as per page 274 of SDTMIGv3.1.2.

Add new term FA (Findings About) to the Domain codelist Add new term FA (Findings About) to the Domain
as per page 274 of SDTMIGv3.1.2.                        codelist

Correct BM to "Bone                         Correct term C49566 for BM code in Domain (C66734 )
Measurements" in the Domain codelist as per codelist
page 277 of SDTMIGv3.1.2. Current description is
"Bone Mineral Density (BMD) Data"

Delete term AEDICT ( C49700) in TSPARMCD (C66738) Delete term AEDICT ( C49700) in TSPARMCD (C66738)
codelist as per page 279 of SDTMIGv3.1.2.         codelist


Delete term Adverse Event Dictionary (C49700) in          Delete term Adverse Event Dictionary (C49700) in
TSPARM (C67152) codelist as per page 279 of               TSPARM (C67152) codelist
SDTMIGv3.1.2.

Delete term DRUGDICT (C49701) in TSPARMCD                 Delete term DRUGDICT (C49701) in TSPARMCD
(C66738) codelist as per page 280 of SDTMIGv3.1.2.        (C66738) codelist

Delete term Drug Dictionary (C49701) in                   Delete term Drug Dictionary (C49701) in
TSPARM(C67152) codelist as per page 280 of                TSPARM(C67152) codelist
SDTMIGv3.1.2.

Delete term MHDICT (CC49702) in TSPARMCD                  Delete term MHDICT (CC49702) in TSPARMCD
(C66738) codelist as per page 281 of SDTMIGv3.1.2.        (C66738) codelist

Delete term Medical Dictionary(C49702) in                 Delete term Medical Dictionary(C49702) in
TSPARM(C67152) codelist as per page 281 of                TSPARM(C67152)
SDTMIGv3.1.2.

Add new term OBJPRIM as per page 281 of                   Add new term OBJPRIM
SDTMIGv3.1.2.

Add new term "Trial Primary Objective" to TSPARM          Add new term "Trial Primary Objective" to TSPARM
(C67152)                                                  (C67152)
Add new term OBJSEC to the TSPARM C67152) codelist Add new term OBJSEC to the TSPARM C67152)
as per page 281 of SDTMIGv3.1.2.                   codelist

Add new term OBJSEC to the TSPARMCD (C66738)             Add new term OBJSEC to the TSPARMCD (C66738)
codelist as per page 281 of SDTMIGv3.1.2.                codelist

Add new term "Trial Secondary Objective" to    Add new term "Trial Secondary Objective" to the
the TSPARM C67152) codelist as per page 281 of           TSPARM C67152)
SDTMIGv3.1.2.

Add new term SPONSOR to the TSPARMCD (C66738)            Add new term SPONSOR to the TSPARMCD (C66738)
codelist as per page 281 of SDTMIGv3.1.2.                codelist

Add new term "Sponsoring Organization" to      Add new term "Sponsoring Organization" to the
the TSPARM (C67152) codelist as per page 281 of          TSPARM (C67152) codelist
SDTMIGv3.1.2.
Expand ECG Results list                                  Expand ECG Results list




Clarify semi-fowlers versus semi-supine, as they are used Body position of semi-fowlers versus semi-supine needs
as synonyms and semi-fowlers not used commonly as a clarification
term in trial protocols.




Change spelling of foetus to fetus x2                    foetus should be fetus

Misspelled term                                          Misspelled term




Misspell                                                 Ileum


Definition misspell                                      British spelling

misspell                                                 misspell
capitalize proper name                                     capitalize proper name

capitalize proper name                                     capitalize proper name -3

capitalize proper name                                     capitalize proper name-2

proper name needs to be capitalized - Henry and Weber      proper name needs capitalization
in definition
capitalize proper name 4                                   capitalize proper name - 4

change British spelling                                    change British spelling

capitalize proper name                                     Pascals

change tesla to Tesla                                      change tesla to Tesla

change becquerel to Becquerel                              change becquerel to Becquerel

change characterised to characterized                      change characterised to characterized

change occuring to occurring                               change occuring to occurring

change stoping to stopping                                 change stoping to stopping

change erthrocytes to erythrocytes                         change erthrocytes to erythrocytes

Consistency with other test codes related to urinary casts LBTEST




Consistency with literature                                LACTICAC to LA




For the urine Protein 24 hour test, we are running into the Add the lab test name Protein 24 Hr with the test code
issue where the units of measure are not going through      PROT24H
our conversion table because the urine Protein 24 Hr
units (ie. mg/day) are different than the random urine
Protein units (ie. mg/dL). The 24 Hour attribute can be
captured in an additional field within the LB domain but
this is not pulled into our conversion table. Can you
please add Protein 24 Hr with the test code PROT24H.

The codelist is not estensible and we believe that there   Add DOSE DELAYED as a term to --ACN codelist
exists no equivalent CDISC term for the action taken of
delaying a dose. We do not think delaying a dose is
equivalent to interrupting the dose. We think interrupting
the dose means to temporarily stop the dose, while
delaying the dose means to alter the dosing schedule.




There is an error in the CDISC Synonym of C70526           Error in CDISC Synonym
There is an error in the CDISC Synonym of C70527         Error in CDISC Synonym of C70527




The corresponding lbtest, lbtestcd are not in the SDTM   D-dimer, one of the fibrin degradation products, consists
control terminology                                      of variously sized pieces of crosslinked fibrin. It is
                                                         produced only after a clot has formed and is in the
                                                         process of being broken down.




The corresponding lbtest, lbtestcd are not in the SDTM   D-dimer, one of the fibrin degradation products, consists
control terminology                                      of variously sized pieces of crosslinked fibrin. It is
                                                         produced only after a clot has formed and is in the
                                                         process of being broken down.




Common terminology                                       for the all terms in the unit code list add synonym with
                                                         mcg for u




Knee to Heel Length is used quite often for the infant   Knee to Heel Length is used quite often for the infant
studies                                                  studies
Partial pressure of carbon dioxide                       Partial pressure of carbon dioxide




Oxygen, partial pressure                                 Oxygen, partial pressure
Issues to map existing company country list against       SDTM-COUNTRY codelist does not contain all ISO3166-
SDTM COUNTRY codelist. SDTM-COUNTRY codelist              1 alpha-3 country codes.
does not contain all ISO3166-1 alpha-3 country codes.
However it is defined as not being extensible




We capture LBTOXGR values of 0 to equate to Normal.       We capture LBTOXGR values of 0 to equate to Normal.
We do not wish to set this value to missing because       We do not wish to set this value to missing because
missing is used when the values or normal ranges are      missing is used when the values or normal ranges are
missing.                                                  missing.



Only international unit terms are available in the CDISC   U/L and other units needed beside IU/L
UNIT terms list: Unit IU/L, Unit IU/mL, Unit IU/kg, Unit
IU/mg, Unit IU/g. The symbol IU is reserved for WHO
International biological reference preparations
(http://www.who.int/biologicals/reference_preparations/en/
). This applies only for the parameters as listed in the
PDF document from WHO. In order to represent original
and standard enzyme activities (because none of the
common enzym reference preparation ist listed in this
document) in a correct unit the addition of the following
terms would be needed: Unit U/L, Unit U/mL, Unit U/kg,
Unit U/mg, Unit U/g. In this context the definition of
"IU" should be re-visited, since the example
mentiones enzymes which seems misleading.




Standard measure of visceral obesity (size of one's belly). SAD - Sagittal Abdominal Diameter is a standard
                                                            measure of visceral obesity (size of one's belly).
An example is an oncology trial where surgery is added      New TSPARMCD for EXISTRT (Existing Treatment)
on to a chemotherapy regimen for one Arm. In this case,
surgery was the ADDON (ADDON = Y) and EXISTRT was
the chemotherapy regimen.
Existing Treatment (TSPARM) for EXISTRT               Existing Treatment (TSPARM) for EXISTRT
(TSPARMCD). An example is an oncology trial where     (TSPARMCD)
surgery is added on to a chemotherapy regimen for one
Arm. In this case, surgery was the ADDON (ADDON = Y)
and EXISTRT was the chemotherapy regimen.
TSPARMCD EXISTRT was also requested on July 16,
2009.
New Term for both TSPARMCD (TRT) and TSPARM              New TSPARMCD = TRT for "Name of Treatment"
(Name of Treatment) requested. In the SDTMIG v3.1.2
implementation guide on page 282.


New Term for both TSPARMCD (TRT) and TSPARM              Add TSPARM (Name of Treatment)
(Name of Treatment) requested. In the SDTMIG v3.1.2
implementation guide on page 282.


New Term for both TSPARMCD (OBJ) and TSPARM               New Term TSPARMCD = OBJ
(OBJECTIVE) requested to be added. Have situation of a
protocol that only lists objectives and does not indicate
whether they are Primary or Secondary so need a
TSPARM/TSPARMCD to cover this.

New Term for both TSPARMCD (OBJ) and TSPARM               New Term TSPARM = OBJECTIVE
(OBJECTIVE) requested to be added. Have situation of a
protocol that only lists objectives and does not indicate
whether they are Primary or Secondary so need a
TSPARM/TSPARMCD to cover this.

Grade 0 Adverse Event:No Adverse Event(Synonym). In New term request and request for change in definition.
addition to the five grades for describibg adverse events, Comment Posted by submitter 2009-07-28 13:15
this term also exists in NCI Common Terminology Criteria Change 'CTCAE' to 'CTCAE v4.0'
for Adverse Events v4.0.Please refer to the owl file at
http://evs.nci.nih.gov/ftp1/CTCAE. New term definitions
exist for grade terms which were provided by the EVS
group at NCI, in CTCAE v4.0.




The current codelist description is "The name of a   Modify description of STENRF codelist
code list that contains terms that reference timepoints
within and without a defined time period." I propose
changing it to "The relative relationship of a
timepoint to a reference timepoint." The current
wording is somewhat awkward and confusing.
Action taken with treatment can be for multiple treatments MULTIPLE value proposed to deal iwth actions taken
(sometimes there is more than one study drug). Then we with multiple study drugs
would QNAM = AEACNR1-n where n is the number of
study drugs, QLABEL is Reported Action Taken with
<Drug>.




For oncology trials, an action taken is often to decrease   Additional action taken with study drug to reflect infusion
the infusion rate. This is not the same as reducing the     rate
dose, as often the total dose received will be the same, it
is the administration interval that is lengthened by
decreasing infusion rate.



In the codelist LBTESTCD (C65047) there are a number Inconsistent CDISC definition for cell counts
of codes for cell counts of all kinds of specific cell types
(The NCI Preferred Term usually is "XXX
Count"). The CDISC definition however uses three
different wordings: 1) "A measurement of the XXX
per unit of a biological specimen." (e.g. MONO) 2)
"A measurement of the XXX in a biological
specimen." (e.g. BLAST) 3) "A count of the
XXX per unit of a biological specimen." (e.g. CD3). I
would prefer to have consistently wording 1).




potentially missing code                                    New Term needed for Total Bilirubin




There are duplicates for Code, Codelist Code and            Duplicates for Code, Codelist Code and Codelist name
Codelist name in EVAL                                       in EVAL
The terms Q.A.M. (every day before noon) and Q.P.M.        Q.A.M. and Q.P.M. missing from FREQ codelist
(every day after noon) are missing from the FREQ
codelist (C71113)




The reason why we want to add 'Stabilization' is to          The reason why we want to add 'Stabilization' is to
comply with regulatory requirements. An AE has to be         comply with regulatory requirements. An AE has to be
followed until resolution or stabilization. With the current followed until resolution or stabilization.
codelist we only know whether the AE is recovered or not
recovered. Stabilization could apply to any diagnosis of
chronic diseases of conditions (present before or starting
during the course of the study) that are not curable/not
expected to recover.

The definition for transverse liver fissure is in the liver def in wrong place
fissure concept. Which concept does CDSIC want, so we
can move the correct data into the correct concept?

This concept is currently not captured in the Lab          Addition of term 'Cortisol, Free' to LBTEST
Terminology.




Addition of Test code to go with the request to add the    Addition of 'CORTISLF' to LBTESTCD
new term Cortisol, Free
Add a synonym for clarification of term                    Add synonym to the LBTEST term 'Cortisol'

Add cm3 as a synonym of mL C28254                          Add cm3 as a synonym of mL C28254


Would you please add OTHER as an allowable value for       Addition of OTHER as an allowable value for the
the EGSTRESC variable within the ECG Result Codelist       EGSTRESC variable
contained within the SDTM Terminology spreadsheet?
By doing this, it will enable an easier record linking
capability between the EG and SUPPQUAL datasets.

HYPO is not specific enough.                               Change HYPO to HYPOCROM
                         Detailed Description                                                NCI Decision

                                                                           remove "ratio" from CDISC definition

                                                                           The original mapping is inaccurate. C35266 is
                                                                           the finding of Anisocytosis. We will re-map this
                                                                           concept to the term C74797 Anisocyte
                                                                           Measurement - We would move the CDISC
                                                                           definition to this term. If you want Anisocytosis
                                                                           as well, let us know.

                                                                           Fine

The new definition should read: A measurement of the May-                  Change definition to: A measurement of the
Hegglin Amonaly (which is characterized by large, misshapen                May-Hegglin anomaly in a blood sample. This
platelets and the presence of Dohle bodies in leukocytes) in a             anomaly is characterized by large, misshapen
blood specimen.                                                            platelets and the presence of Dohle bodies in
                                                                           leukocytes.
                                                                           Corresponds to C64433 Alanine
                                                                           Aminotransferase. This synonym is correct and
                                                                           NCI already has it as an NCI SY.

I cut-and-paste some additional very useful information provided at        We agree, the change of CDISC PT from m3 to
the time by Connie (sorry for putting you in the spot!: I did a little     scm for C68858, Standard Cubic Meter, is
digging and these two concepts are in fact two distinct concepts           good. 'scm' is an NCI synonym for this term
with two different definitions.                                            already. scm and m3 are sufficiently different
                                                                           enough that they have separate NCI codes.

CN 35267 is mapped to the lab result and should be mapped to               We would like to re-map this term to the
Poikilocyte Measurement, which needs to be created. The CDISC              concept C79602 Poikilyocyte Measurement,
PTs and definitions are correct.                                           which has been created. We will transfer the
                                                                           existing CDISC PT, SY, Def, etc. to this new
                                                                           concept if you agree.

Old Def: A clinical research protocol generally refered to as a pilot      Agree.
or feasibility trial that aims to prove the concept of the new
intervention in question. New Def: A clinical research protocol
generally referred to as a pilot or feasibility trial that aims to prove
the concept of the new intervention in question.

Old Def: A clinical research protocol generally refered to as a well- Agree.
controlled and pivotal trial that aims to prove the mechanism of
action of the new intervention in question. A pivotal study will
generally be well-controlled, randomized, of adequate si

New Def: A class of disorders that encompasses conditions                  Agree.
resulting from a congenital, familial hereditary trait or genetic
abnormality as is manifested by a characteristic set of symptoms
and signs.
New Def: Published by The Regenstrief Institute, the Logical               Agree.
Observation Identifiers Names and Codes covers clinical and
clinical laboratory terminology.
New Def: A measurement of the Dohle body (blue-gray, basophilic,           Agree.
leukocyte inclusions located in the peripheral cytoplasm of
neutrophils) in a biological specimen.
New: Any depression occurring in a positive t wave.                        Agree.
Change 'occuring' to 'occurring' in definition                            Agree.

New: An electrocardiographic finding of an organized rhythmic       Agree.
contraction of the atria which is generally at a rate of 200-300
beats per minute. (NCI)
New: The Fahrenheit temperature scale is named after the German Agree.
physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724.
In this scale, the freezing point of water is 32 degrees Fahrenheit
and the boiling point is 212 degrees, placing the boilin

Marriage is spelled wrong in def.                                         Agree.

New: A unit of force which, when applied in a vacuum to a body            NCI suggests changing to 'meter per second
having a mass of one kilogram, causes an acceleration of one              squared'.
meter/sec2. It is equal to 10E5 dynes.
The term should be Barbiturates instead of Barbiturate because we         Agree
are measuring the drug class. This is consistant with other drug
classes.
To be consistent with other definitions change A count of the             Agree
basophils per unit of a biological specimen to A measurement of of
the basophils per unit of a biological specimen.

Change text from measure to measurement in the following text.            Agree
New text should read: A relative measurement (ratio or
percentage) of the basophils to leukocytes in a biological
specimen.
Add synonym of SGOT                                                       Agree

Change the text from measure to measurement. New text: A                  Agree
relative measurement (ratio or percentage) of the blasts to
leukocytes in a biological specimen.


The CDSIC submission value should be without the word ratio.           Agree
New text:BUN/Creatinine. There are only a couple of values that
have the word ratio. THis will make all of the ratio terms consistent.

Add Total Cholesterol as a synonym.                                       Agree
Request the addition of two new terms "LIFE-THREATENING and               Send to CDISC to determine course of action.
FATAL" to the AESEV codelist. In addition to providing more detail        TOXGR code list has the grade 1-5 values
for the differentiation of severity of an AE that is not categorized by   whereas AESEV has only 3 (MILD,
a standard terminology, it would also provide a more log                  MODERATE, SEVERE).
Please see text in Justification section.                           Send to CDISC to determine course of action.




Codelist STENRF currently has terms AFTER, BEFORE, DURING, This is fine if CDISC wants it.
DURING/AFTER, UNKNOWN. If a con med CRF reports that
ONGOING?=No, but does not include a stop time, we know that
CMENRF is not "AFTER", but we don't know if it was BEFORE or
DURING. (If it started DURING then we know it ended DURING,
but if it started BEFORE we have no clue as to when it ended.) A
new term BEFORE/DURING needs to be added to parallel the
wishiwashiality of the existing term DURING/AFTER. Otherwise the
sponsor cannot represent the specificity of information that is
available. This addition will enable the codelist to be "closed" and
still cover all cases. Recommend the following description, to be
consistent with other existing descriptions in the codelist: "Before a
certain point or period in time or within a certain period of time."




Modify definition to A measurement of the elliptically shaped       Agree
erythrocytes in a biological specimen. Add synonym Ovalocytes.

Modify definition to A measurement of the eosinophils per unit fo a Agree
biological specimen.
Modify definition to A relative measurement (ratio or percentage) of Agree
the eosinophils to leukocytes in a biological specimen.

Add synonym Oestradiol.                                             Agree
Modify the existing term of FOLICAC to VITB9.                       Agree

The definition should read: A measurement of the gamma glutamyl Agree; Transpeptidase is correct however
transferase in a biological specimen.                           transferase is more formal.
Add synonym Pregnancy Test                                      Agree

Add synonym Glutamic Acid for Glutamate.                            Agree

On rows 407 to 412 of published spreadsheet, the CDISC                Agree
submission value in column E does not match the CDISC preferred
term in column F. This is one of those codelists in which the term in
column E should equal the term in Column F. It looks like a copy
and paste error.
New text should read: A measurement of the atypical lymphocytes Agree
per unit in a biological specimen.
Definition new text for Lymphocytes Atypical/Leukocytes: A relative Agree
measurement (ratio or percentage) of the lymphocytes to
leukocytes in a biological specimen.
Correct text for LYMLE is: A relative measure (ratio or percentage) Agree
of the atypical lymphocytes to leukocytes in a biological specimen.

Change definition of Reactive Lymphocytes/Lymphocytes to: A        Agree
relative measurement (ratio or percentage) of the reactive
lymphocytes (lymphocytes which have become large due to an
antigen reaction) to all lymphocytes in a biological specimen.

New text should read: A measurement of the macrocytes per unit     Agree
of a biological specimen.
See Justification                                                  Life Threatening is listed as a CDISC PT
                                                                   because it is listed in column F of the CT
                                                                   spreadsheet but differs from the column E
                                                                   submission value of 4, which is also a CDISC
                                                                   PT. As a business rule, we wouldn't want a
                                                                   value to exist as a PT that isn't part of a
                                                                   codelist. CDISC to discuss.
Old Def: An Southern Africa, occupying an island in the Indian    Agree
Ocean, east of Madagascar. New Def: A country in Southern
Africa, occupying an island in the Indian Ocean, east of
Madagascar.
Place definition for Bermuda on Controlled Terminology            Agree
spreadsheet: A group of islands in the North Atlantic Ocean, east
of South Carolina.
Change Ery. Mean Corpuscluar HB Concentration to Ery. Mean        Agree
Corpuscluar HGB Concentration to add the B in HB for consistency
in the abbreviation of hemaglobin.

New text should read: A measurement of the microcytes per unit of Agree
a biological specimen.
New text should read: A measurement of the monocytes per unit of Agree
a biological specimen.
New text should be: A relative measurement (ratio or percentage) Agree
of the monocytes to leukocytes in a biological specimen.

New text should be: A relative measurement (ratio or percentage)   Agree
of the myeloblasts to leukocytes in a biological specimen.

New text should be: A relative measurement (ratio or percentage)   Agree
of the myelocytes to leukocytes in a biological specimen.

New text: A measurement of the neutrophils per unit of a biological Agree
specimen.
New text: A measurement of the banded neutrophils per unit of a     Agree
biological specimen.
New test: A relative measurement (ratio or percentage) of the       Agree
banded neutrophils to leukocytes in a biological specimen.

New test: A relative measurement (ratio or percentage) of the      Agree
neutrophils to leukocytes in a biological specimen.
New text: A measurement of the Pelger Huet Anomaly (neutrophils Agree - Change definition just slightly to sound
and eosinophils nuclei appear rod like, spherical or dumbbell   more grammatically correct: A measurement of
shaped) in a biological specimen.                               the Pelger Huet Anomaly (nuclei of neutrophils
                                                                and eosinophils appear rod-like, spherical or
                                                                dumbbell shaped) in a biological specimen.

Add synonym: Phosphorus                                                  Phosphorus is the element and is not
                                                                         analogous structurally to phosphate, which has
                                                                         side chains. However, Phosphorous is
                                                                         analogous to phosphate. NCI suggests
                                                                         Phosphorous be the synonym instead of
                                                                         Phosphate.
The CDISC defintion for the "Lost to follow-up" says: "The loss or Send to CDISC for resolution.
lack of continuation of follow-up after a study has officially closed.
See Follow-up. (NCI)" In my organization this term was used rather
with a definition as follows: "The lost to follow-up means that there
was no further contact, independent of the study epoch where the
subject got lost."
Shire‟s current definition of “severe” - : The AE is incapacitating          Send to CDISC for review
and the subject is unable to work or complete usual activity.
CDISC‟s current definition of “severe” - : A type of adverse event
that requires intensive therapeutic intervention.The event interrupts
usual activities of daily living, or significantly affects clinical status.
The event possesses a significant risk of harm to the research
participant and hospitalization may be required Shire‟s physicians
preferred definition of “severe” - : The event interrupts usual
activities of daily living, or significantly affects clinical status, and/or
a type of AE that requires intensive therapeutic intervention.



                                                                         Agree

                                                                         Agree

                                                                         Agree

                                                                         Agree

                                                                         Agree


                                                                         Agree

                                                                         Agree


                                                                         Agree
                                                                         Agree


                                                                         Agree
                                                                         Agree

                                                                         Agree


                                                                         Agree
Change definition of NCOMPLT codlist (C66727) to "If the subject Send to CDISC for review
completed the study or segment of the study (e.g. Treatment if
data is collected at that granularity) then the term will be
"COMPLETED". If the subject does not complete the study or
segment of the study then this is the reason that a subject
discontinued." Current definition of "The reason that a subject was
discontinued from a clinical trial."




The use of the term 'growth hormone' as a general class of        Send to CDISC for review
hormones may be used to denote any hormone that stimulates cell
growth in the popular lexicon. I am unsure whether CDISC is using
the term Growth Hormone Measurement as a broad category to
denote the measurement of any 'growth' hormones or whether it
really does mean Somatotrophin. In the SDTM both of these terms
are synonyms of each other which makes me think that perhaps
CDISC does really mean Growth Hormone = Somatotrophin.
CDISC needs to determine whether these two should remain
separate on the codelist or if not, to pick one PT and create the
other term as a synonym. Also CDISC needs to resolve the issue
of whether they mean Somatotrophin or Somatotropin (without the
h).


C74634 Bite Cells/Erythrocytes appears twice in LBTEST and             Send to CDISC for review
LBTESTCD codelist. Remove one.
The CDISC PT for C74761: Albumin/Creatinine Ratio, C74894:             Send to CDISC for review
Albumin/Globulin Ratio, C74753: BUN/Creatinine Ratio all contain
the word 'Ratio'. All other terms of this type do not contain the word
Ratio in the PT. For consistency, CDISC may want to consider
removing the term Ratio from the PT.

Please add the terms as CDISC synonyms: C42966 Ointment -             Send to CDISC for review
oint; C42993 Suppository - supp; C42887 Aerosol - aer; C42994
Suspension - susp.

Im conjunction with decision regarding change request 19454,          Send to CDISC for review
please change CDISC PT from Folic Acid to Vitamin B9. Keep
Folic Acid as a synonym.
Change name of codelist from "Patient Ethnic Group" to "Ethnic        Send to CDISC for review
Group"




Typo in term "Phase IIIaTrial" needs to be corrected to "Phase IIIa   Agree
Trial". Space is missing.
Change "CDISC Code List" drop down list in this form to 1) remove        1) NCI is open to suggestions for a better way
"SDTM" from each codelist name since these codelists are not just        to differentiate source of codelist. We feel this is
applicable for SDTM so it's very confusing and misleading 2)             necessary since currently we have four different
please sort codelist alphabetically - order in dropdown list seems to    groups submitting codelists, some of which
be random and it's difficult to find a codelist without searching        overlap and some of which are hybrids of
through the whole list.                                                  existing SDTM lists. Although SDTM is currently
                                                                         the only codelist mentioned on the change
                                                                         control website, we anticipate the other CDISC
                                                                         subgroups will want to make use of this change
                                                                         control process. We're open to alternative
                                                                         proposals to address this issue. 2) NCI agrees
                                                                         with alphabetizing codelist on the Request Form
                                                                         if this is helpful for CDISC. As of now, it is in the
                                                                         order that the codelists appear on the published
                                                                         spreadsheet.



In normal urine, the amount of indican excreted is small. It is        Send to CDSC for review.
increased with high protein diets or inefficient protein digestion. If
not digested properly, or if the wrong type of proteins are ingested,
bowel putrefaction can occur. Problems with protein digestion can
be caused by overgrowth of anaerobic bacteria, intestinal
obstruction, stomach cancer, low stomach acid, parasitic
infections, malabsorptive syndromes (sprue, etc.), fungal
infections, lack of digestive enzymes, or liver problems. Please see
following website for more information:
http://biocenterlab.org/tests/urine/indican.shtml


CDISC definition of Pappenheimer Bodies is unclear.                      Send to CDISC for review. FYI Pappenheimer
Pappenheimer Bodies are found in siderocytes. However, the               bodies are found in many mature and immature
CDISC defintion says: A measurement of the Pappenheimer                  red blood cells as well as sickle cells not just in
Bodies (violet or blue staining, ferritin granules usually found along   siderocyte cells, so we suggest not specifying
the periphery of the red blood cells) in a biological specimen. Does     siderocyte counts as part of the definition as it is
this mean that the number of Pappenheimer Bodies per siderocyte          too single-cell specific. Not all cells that contain
is counted or is it possible to use this for the count of siderocytes    Pappenheimer bodies can be considered
or aren't Pappenheimer Bodies counted?                                   siderocytes.

1) C74630 C65047 Laboratory Test Code BLASTLM BLASTLM                    1) Agree, CDISC synonyms are incorrect - NCI
Leukemic Blasts; Lymphocytes; Lymphoblasts; Immunoblastic -              suggests keeping SY 'Leukemic Blasts', altering
Should the second synonym be 'Lymphocyte Blasts'rather than              'Lymphoblasts' to 'Leukemic Lymphoblasts', and
'Lymphocytes'? 2) Within the 2009-02-17 posted spreadsheet,              removing the others. 2) Concerns change
there are duplicate rows for the term BTECERBC: LBTEST: rows             request already submitted 19788 - we have
1367 and 1538 (definitions are slightly different but the terms are      agreed to take off the duplicate term 'Bite
the same) LBTESTCD: rows 945 and 1116 (ditto) 3) There appear            Cells/Erythrocytes' on the LBTEST and
to be 2 codes for the same test, where the TESTCD is simply              LBTESTCD codelist 3) These terms are
worded differently: C74767 C65047 Laboratory Test Code                   synonymous. We suggest CDISC removes
FGRANCS FGRANCS Fine Granular Casts A measurement of                     C74769 from list.
the fine granular casts present in a urine specimen. C74769
C65047 Laboratory Test Code CSGRANF CSGRANF Granular
Fine Casts A measurement of the fine granular casts present in a
urine specimen.
The CDASH Medical History team proposes that "Pack Years" be        Send to CDISC for review: NCI term 'Pack Year'
added to the terminology code lists. Pack Years is a commonly       C73993 with Definition: A quantification of
term used to describe the amount a person has smoked over time.     lifetime tobacco exposure defined as (number
One pack year is defined as 20 manufactured cigarettes (1 pack)     of cigarettes smoked per day x number of years
smoked per day for one year.                                        smoked)/20. One pack-year is smoking 20
                                                                    cigarettes a day for one year.

The CDASH project team requests that QD be added the              SEND also has interest in the use of QD. In
terminology codelists to mean every day. The closest term is "Q24 NCIt it maps to C25473 'Daily' with definition:
hr", however, QD is commonly used by clinicians in medical charts Occurring or done each day.
and on case report forms.

Old Def: A measurement of the granular (course and fine) casts      Send to CDISC for review.
present in a urine specimen. New Def: A measurement of the
granular (coarse and fine) casts present in a urine specimen.

Name of this codelist should be changed to Subject Ethnic Group     Send to CDISC for review.
as per page 272 of the SDTMIGv3.1.2 - row 1 in the table.

Add new term for CE - Clinical Events to Domain codelist as per     Send to CDISC for review.
page 274 of SDTMIGv3.1.2.

Add new term FA (Findings About) to the Domain codelist as per      Send to CDISC for review.
page 274 of SDTMIGv3.1.2.

Correct BM to "Bone Measurements" in the Domain codelist as         Send to CDISC for review.
per page 277 of SDTMIGv3.1.2. Current description is "Bone
Mineral Density (BMD) Data"


Delete term AEDICT ( C49700) in TSPARMCD (C66738) codelist          Send to CDISC for review.
as per page 279 of SDTMIGv3.1.2.


Delete term Adverse Event Dictionary (C49700) in TSPARM             Send to CDISC for review.
(C67152) codelist as per page 279 of SDTMIGv3.1.2.


Delete term DRUGDICT (C49701) in TSPARMCD (C66738)                  Send to CDISC for review.
codelist as per page 280 of SDTMIGv3.1.2.

Delete term Drug Dictionary (C49701) in TSPARM(C67152)              Send to CDISC for review.
codelist as per page 280 of SDTMIGv3.1.2.


Delete term MHDICT (CC49702) in TSPARMCD (C66738) codelist Send to CDISC for review.
as per page 281 of SDTMIGv3.1.2.

Delete term Medical Dictionary(C49702) in TSPARM(C67152)            Send to CDISC for review.
codelist as per page 281 of SDTMIGv3.1.2.


Add new term OBJPRIM as per page 281 of SDTMIGv3.1.2.               Send to CDISC for review.


Add new term "Trial Primary Objective" to TSPARM (C67152) as        Send to CDISC for review.
per page 281 of SDTMIGv3.1.2.
Add new term OBJSEC to the TSPARM C67152) codelist as per             Send to CDISC for review.
page 281 of SDTMIGv3.1.2.

Add new term OBJSEC to the TSPARMCD (C66738) codelist as              Send to CDISC for review.
per page 281 of SDTMIGv3.1.2.

Add new term "Trial Secondary Objective" to the             Send to CDISC for review.
TSPARM C67152) codelist as per page 281 of SDTMIGv3.1.2.


Add new term SPONSOR to the TSPARMCD (C66738) codelist as Send to CDISC for review.
per page 281 of SDTMIGv3.1.2.

Add new term "Sponsoring Organization" to the TSPARM                  Send to CDISC for review.
(C67152) codelist as per page 281 of SDTMIGv3.1.2.

Request from Brian Harrington: These findings fall under the          NCI agrees with including AV Mobitz I, AV
“Result” code list. Please see the below from our Director of         Mobitz II. NCI asks for a better term than
International Cardiology: An authoritative reference would be         'Artificial Pacemaker'; we suggest 'Paced
Chou‟s Electrocardiography In Clinical Practice, 5th Ed., by          Rhythm'. NCI suggests 'QTC Prolongation >500
Surawica and Knilans (Saunders, 2001). Definitions: AV MOBITZ I -     msec' for final term. NCI has determined that all
AV conduction block characterized by gradual lengthening of the       U waves are abnormal so 'U Waves Abnormal'
PR interval leading to a P wave which is not conducted, and a         would be a redundant term therefore we
shortening of the PR after the nonconducted P wave; AV MOBITZ         suggest to keep U Waves as it is.
II - AV conduction block characterized by abrupt AV block without a
change in the PR interval before or after the nonconducted P wave;
ARTIFICIAL PACEMAKER - ECG pattern recorded in a subject
who has either a permanent or temporary electronic pacemaker (or
Implantable Cardiac Defibrillator with pacing capabilities);
PROLONGED QTC - Prolonged QT interval (corrected for heart
rate) which is associated with increased risk of sudden death. In
addition, we are requesting the removal of the current finding (U
WAVES) and replace it with the new finding (U WAVES
ABNORMAL). This is due to all U waves not being abnormal.



In the clinical trial context, blood pressure is most commonly        Send to CDISC for review.
measured in the supine and semi-supine position. These are the
common terms used, used by the study sites. Feedback received
is that terms such as semi-fowlers are not very usable (not really
accepted for use). Furthermore, there is an issue of different
interpretations of what this is.

foetus should be fetus                                                Agree. Send to CDISC for review

singlemasked should be single-masked                                  Agree. Send to CDISC for review




definition ilium should be ileum                                      Agree. Send to CDISC for review


repolarisation should be repolarization                               Agree. Send to CDISC for review

corporus should be corpus                                             Agree. Send to CDISC for review
capitalize Siemens in definition                                      Agree. Send to CDISC for review

capitalize Siemens in definition                                      Agree. Send to CDISC for review

capitalize Siemens in definition                                      Agree. Send to CDISC for review

capitalize Weber in definition                                        Agree. Send to CDISC for review

capitalize Kelvin in definition                                       Agree. Send to CDISC for review

change foetus to fetus                                                Agree. Send to CDISC for review

change pascals to Pascals                                             Agree. Send to CDISC for review

change tesla to Tesla                                                 Agree. Send to CDISC for review

change becquerel to Becquerel                                         Agree. Send to CDISC for review

change characterised to characterized                                 Agree. Send to CDISC for review

change occuring to occurring                                          Agree. Send to CDISC for review

change stoping to stopping                                            Agree. Send to CDISC for review

change erthrocytes to erythrocytes                                    Agree. Send to CDISC for review

All lab test codes related to urinary casts are prefixed with CS with Send to CDISC for review
the exception of fine granular casts which has a test code of
FGRANCS. For consistency reasons, please change this test code
to CSFGRAN
For Lactate Dehydrogenase we use LDH (the common                      Send to CDISC for review
abbreviation) as the test code. Can we consider changing
LACTICAC to LA to keep a consistent approach?

For the urine Protein 24 hour test, we are running into the issue     Send to CDISC for review
where the units of measure are not going through our conversion
table because the urine Protein 24 Hr units (ie. mg/day) are
different than the random urine Protein units (ie. mg/dL). The 24
Hour attribute can be captured in an additional field within the LB
domain but this is not pulled into our conversion table. Can you
please add Protein 24 Hr with the test code PROT24H.



See justification for request                                         Send to CDISC for review




The CDISC Synonym for C70526 (GBq/ug) says "Gigabecquerel             Transcription error. Correct in NCIt but not on
per microgram; MBq/ug, Megabecquerel per microgram". This is          CT terminology spreadsheet.
wrong. It should be "...; MBq/ng, Megabecquerel per nanogram"
The CDISC Synonym for C70527 (GBq/mg) says "Gigabecquerel                  Agree to change SYs.
per Milligram; MBq/mg, Megabecquerel per Milligram". This is
wrong. It should be "...; MBq/ug, Megabecquerel per Microgram"

The fragments of the disintegrating fibrin in the clot are called fibrin Send to CDISC for review.
degradation products (FDP). One of the FDPs produced is D-
dimer, which consists of variously sized pieces of crosslinked
fibrin. D-dimer is normally undetectable in the blood and is
produced only after a clot has formed and is in the process of
being broken down. Measurement of D-dimer can tell your doctor
that something has increased above normal the body's clotting
mechanisms.

The fragments of the disintegrating fibrin in the clot are called fibrin   Send to CDISC for review. Suggest to add 'D-
degradation products (FDP). One of the FDPs produced is D-                 Dimer' as a lbtest term with definition ' A
dimer, which consists of variously sized pieces of crosslinked             measurement of the fibrin degradation
fibrin. D-dimer is normally undetectable in the blood and is               fragments, or d-dimers, in a biological
produced only after a clot has formed and is in the process of             specimen.'
being broken down. Measurement of D-dimer can tell your doctor
that something has increased above normal the body's clotting
mechanisms.

Numbers that I found 48152, 67306, 67327, 67394, 67396, 67397, Agree
70523, 70526, 70530, 70581, 71205, 71210, 71211. I may have
missed a few so please search the file to ensure we have all terms




Knee to Heel Length is used quite often for the infant studies             Send to CDISC for review

Partial pressure of carbon dioxide                                         Send to CDISC for review: New Term in NCIt
                                                                           Partial Pressure of Carbon Dioxide
                                                                           Measurement Def: Measures the pressure of
                                                                           carbon dioxide dissolved in the blood and how
                                                                           well oxygen is able to move from the airspace of
                                                                           the lungs into the blood.

Oxygen, partial pressure                                                   Send to CDISC for review: Partial Pressure of
                                                                           Oxygen Measurement C71251 Def: Measures
                                                                           the pressure of oxygen dissolved in the blood
                                                                           and how well oxygen is able to move from the
                                                                           airspace of the lungs into the blood.
As far as I understand the current published CDISC COUNTRY               Part I - Isle of Man - NCI Thesaurus
codelist uses (such as HL7) the ISO3166-1 alpha-3 country                Code: C44480; Definition: An island in the
codelist. Additionally it is defined to be not extensible. However the   Irish Sea, between Great Britain and Ireland.
published CDISC COUNTRY codelist does (for whatever reason)              Two other islands are not currently in the
not contain all elements of the ISO3166-1 alpha-3. E.g. the              Thesaurus. Saint Barthelemy and the
following elements of ISO3166-1 alpha-3 are missing: IMN = Isle of       northern part of Saint Martin is part of
Man; BML = Saint Barthelemy; MAF = Saint Martin. And two                 France and the southern part of Saint Martin
elements do have a different three letter code: Jersey = JEY in
                                                                         is part of the Dutch Antilles. Requester
ISO3166 and JRE in CDISC; Serbia = SRB in ISO3166 and SCG
                                                                         needs to be more specific which portion of
in CDISC. All in all ISO3166 has never been stable and will not be
                                                                         the island of St. Martin they are requesting.
stable over time. So I think it does not make sense to define a "non
                                                                         Part II - SCG (Serbia - Current in CDISC) is
extensible" codelist. Why not simply refer to the current version of
ISO3166? They have a process in place how to accomodate the              transitionally reserved by ISO until end of
inevitable changes in the list of countries on earth.                    2009 when it switches to SRB. Therefore
                                                                         CDISC should probably make this update by
                                                                         the end of the year but sooner if possible.
                                                                         JRE is a transcription error on the SDTM CT
                                                                         spreadsheet. JEY is in the Thesaurus as a
                                                                         CDISC PT. This needs to be updated on the
                                                                         CT spreadsheet.


We capture LBTOXGR values of 0 to equate to Normal. We do not We have the term Absent Adverse Event
wish to set this value to missing because missing is used when the (C75533) in the thesaurus with Definition:
values or normal ranges are missing.                               Grade 0 is universally defined as absence of
                                                                   Adverse Events or within normal limits or
                                                                   values. This would be what the value of 0 would
                                                                   map to in this case.
Only for the LB paramters where the WHO International Biological         C67456 Unit per Liter - An arbitrary unit of
Reference Preparations existed as listed in the WHO document the         substance concentration equal to the
"IU" can be used:                                                        concentration at which one liter of mixture
http://www.who.int/bloodproducts/catalogue/bpromay06.pdf. In this        contains one unit of a substance. C77607 Unit
list no common enzymes are listed e.g. ALP, ALT, AMYLASE,                per Milliliter - An arbitrary unit of substance
AST. Using for these paramters e.g. IU/L would not be corrected          content expressed in unit(s) per milliliter.
because there is no WHO reference preparation published.                 C67465 Unit per Kilogram - An arbitrary unit of
However, since catal (the SI unit) is not commonly used as               substance content expressed in units of
standard representation it would be very good to be able to present      biological activity per unit of mass equal to one
enzym activities with a correct unit.                                    kilogram. Unit per kilogram is also used as a
                                                                         dose calculation unit expressed in arbitrary
                                                                         units per one kilogram of body mass. C73780
                                                                         Unit per Milligram - An arbitrary unit of
                                                                         substance content expressed in unit(s) per
                                                                         milligram. C77606 Unit per Gram - An arbitrary
                                                                         unit of substance content expressed in unit(s)
                                                                         per gram.


SAD - Sagittal Abdominal Diameter is a standard measure of               This is a viable measurement. NCI suggests to
visceral obesity (size of one's belly).                                  add. It will be a new NCI term.
EXISTRT = Existing Treatment; An example is an oncology trial            Will this term be added as part of a terminology
where surgery is added on to a chemotherapy regimen for one              package at some point? If so, suggest to let
Arm. In this case, surgery was the ADDON (ADDON = Y) and                 Mary know that and close out the request. If not,
EXISTRT was the chemotherapy regimen.                                    we can add these terms. They will be new NCI
                                                                         terms.
Existing Treatment (TSPARM) for EXISTRT (TSPARMCD). An                     Will this term be added as part of a terminology
example is an oncology trial where surgery is added on to a                package at some point? If so, suggest to let
chemotherapy regimen for one Arm. In this case, surgery was the            Mary know that and close out the request. If not,
ADDON (ADDON = Y) and EXISTRT was the chemotherapy                         we can add these terms. They will be new NCI
regimen. TSPARMCD EXISTRT was also requested on July 16,                   terms.
2009.

New Term for both TSPARMCD (TRT) and TSPARM (Name of                Will this term be added as part of a terminology
Treatment) requested. In the SDTMIG v3.1.2 implementation           package at some point? If so, suggest to let
guide on page 282.                                                  Mary know that and close out the request. If not,
                                                                    we can add these terms. This will be new NCI
                                                                    term.
New Term for both TSPARMCD (TRT) and TSPARM (Name of                Will this term be added as part of a terminology
Treatment) requested. In the SDTMIG v3.1.2 implementation           package at some point? If so, suggest to let
guide on page 282.                                                  Mary know that and close out the request. If not,
                                                                    we can add these terms. This will be new NCI
                                                                    term.
New Term for both TSPARMCD (OBJ) and TSPARM (OBJECTIVE) Will this term be added as part of a terminology
requested to be added. Have situation of a protocol that only lists package at some point? If so, suggest to let
objectives and does not indicate whether they are Primary or        Mary know that and close out the request. If not,
Secondary so need a TSPARM/TSPARMCD to cover this.                  we can add these terms. C49155 Objective - A
                                                                    goal or aim to be accomplished or attained.

New Term for both TSPARMCD (OBJ) and TSPARM (OBJECTIVE)                    Will this term be added as part of a terminology
requested to be added. Have situation of a protocol that only lists        package at some point? If so, suggest to let
objectives and does not indicate whether they are Primary or               Mary know that and close out the request. If not,
Secondary so need a TSPARM/TSPARMCD to cover this.                         we can add these terms. C49155 Objective - A
                                                                           goal or aim to be accomplished or attained.

The definition of the following terms in NCI Common Terminology            See request 22280; Request to add new term
Criteria for Adverse Events v4.0 are as follows: Codelist Code             has been previously submitted. CDISC has
C66784 CTCAE Code E1005 CTCAE Definition An adverse                        chosen to have its own definitions outwith
event that is asymptomatic; or involves mild or minor symptoms; or         CTCAE. Chris/CDISC can agree or disagree to
is of marginal clinical relevance; or consists of clinical or diagnostic   implement this.
observations alone; or for which intervention is not indicated; or for
which only non-prescription intervention is indicated. Codelist Code
C66784 CTCAE Code E1006 CTCAE Definition An adverse
event for which only minimal, local, or noninvasive intervention
(e.g. packing, cautery) is indicated; or that limits instrumental
activities of daily living (ADLs, e.g., shopping, laundry,
transportation, or ability to conduct finances). Codelist Code
C66784CTCAE Code E1007 CTCAE Definition An adverse
event that is medically significant but not life-threatening; or for
which inpatient care or prolongation of hospitalization are
indicated; or that is an important me ical event that does not result
in hospitalization, but may jeopardize the patient or may require
intervention either to prevent hospitalization, to prevent the AE
from becoming life-threatening or causing death; or that is
disabling; or that results in persistent or significant disability,
The current codelist description is "The name of a code list that          Send to CDISC for review.
contains terms that reference timepoints within and without a
defined time period." I propose changing it to "The relative
relationship of a timepoint to a reference timepoint."
Action taken with treatment can be for multiple treatments               Send to CDISC for review. FYI C17648 Multiple -
(sometimes there is more than one study drug). Then we would             Having, relating to, or consisting of more than
QNAM = AEACNR1-n where n is the number of study drugs,                   one individual, element, part, or other
QLABEL is Reported Action Taken with <Drug>.                             component; manifold.




For oncology trials, an action taken is often to decrease the            Send to CDISC for review. FYI C15388 Infusion
infusion rate. This is not the same as reducing the dose, as often       Procedure - A method of putting fluids, including
the total dose received will be the same, it is the administration       drugs, into the bloodstream. Also called
interval that is lengthened by decreasing infusion rate.                 intravenous infusion.




In the codelist LBTESTCD (C65047) there are a number of codes            NCI agrees that consistency should be followed
for cell counts of all kinds of specific cell types (The NCI Preferred   - 1) C74606 CD19; C74607 CD3; C74608 CD4;
Term usually is "XXX Count"). The CDISC definition however uses          C74609 – Change „count‟ to „measurement‟ and
three different wordings: 1) "A measurement of the XXX per unit of       „per unit of‟ to „in‟ in all definitions. 2) C51948
a biological specimen." (e.g. MONO) 2) "A measurement of the             WBC – Change count to measurement in
XXX in a biological specimen." (e.g. BLAST) 3) "A count of the XXX       definition. 3) There are 19 cell count terms
per unit of a biological specimen." (e.g. CD3). I would prefer to        whose definition contains 'per unit of a
have consistently wording 1).                                            biological specimen (C64801, C74699, C64818,
                                                                         C64830, C64470, C64549, C64550, C51949,
                                                                         C64821, C64822, C74631, C64823, C74632,
                                                                         C74662, C63321, C51951, C74621, C51947,
                                                                         C51946) and 19 cell count terms whose
                                                                         definition contains 'in a biological specimen.'
                                                                         (C74700, C74703, C74701, C74604, C74658,
                                                                         C74659, C74613, C74661, C74615, C74705,
                                                                         C79602, C74618, C74620, C74622, C74629,
                                                                         C74706, C74625, C74707, C74708). Since the
                                                                         ratio cell count terms (those terms in which the
                                                                         ratio of two cell types is being measured (such
                                                                         as 'Monoblasts/Leukocytes') in CDISC CT all
                                                                         end with 'in a biological specimen', NCI
                                                                         suggests changing the definitions of the first set
                                                                         of terms.




In the LBTESTCD codelist, there are codes for Bilirubin, Direct          Total Bilirubin (the term that is being requested)
Bilirubin and Indirect Bilirubin. However I do not see a code for        would map to the existing code for Bilirubin (that
Total Bilirubin.                                                         is already in the CT spreadsheet). Perhaps we
                                                                         would need to change the PT to clarify and this
                                                                         might be a good idea to do for all cases in
                                                                         which we have a grouping of similar terms.
                                                                         However Total Bilirubin can also be put in as a
                                                                         SY.

There are duplicates for Code, Codelist Code and Codelist name in Change code for Parent to C42709. This is a
EVAL. C42708 C78735 Evaluator CHILD CHILD           A son or a transcription error but is correct in EVS.
daughter. C42708 C78735 Evaluator PARENT PARENT A
mother or a father.
The terms Q.A.M. (every day before noon) and Q.P.M. (every day         We have both terms in the Thesaurus; C64595
after noon) are missing from the FREQ codelist (C71113)                Every Morning (SY QAM) and C64596 Every
                                                                       Evening (SY QPM). Suggest CDISC definition
                                                                       to be 'Every morning, before noon' and 'Every
                                                                       evening, after noon' OR 'Occurring or done
                                                                       every morning/evening sometime before/after
                                                                       noon.'

The reason why we want to add 'Stabilization' is to comply with        NCIt contains the Term 'Stability' (C54072) with
regulatory requirements. An AE has to be followed until resolution     Defintion: The quality of being free from change
or stabilization. With the current codelist we only know whether the   or variation or not taking part readily in chemical
AE is recovered or not recovered. Stabilization could apply to any     change. Decision to add or create new terms is
diagnosis of chronic diseases of conditions (present before or         up to CDISC.
starting during the course of the study) that are not curable/not
expected to recover.



the definition for transverse liver fissure is in the liver fissure    This may have been either an incorrect
concept. Which concept does CDSIC want, so we can move the             mapping or an incorrect definition. Does CDISC
correct data into the correct concept?                                 want the term C32996 'Liver Fissure' or C33806
                                                                       'Transverse Fissure'?
Listed are links to information regarding the test: Cortisol, Free;    Send to CDISC Lab team for review.
ARUP: http://www.aruplab.com/guides/ug/tests/0098391.jsp; Mayo:
http://www.mayomedicallaboratories.com/test-
catalog/Overview/91644; QUEST:
http://www.questdiagnostics.com/hcp/testmenu/jsp/showTestMenu.
jsp?fn=21469P.html&labCode=SJC;

Addition of test code 'CORTISLF' to go with the request to add the     Send to CDISC Lab team for review.
new term 'Cortisol, Free'
Addition of the synonym 'Total Cortisol' to the existing LBTEST        Send to CDISC Lab team for review.
term 'Cortisol' for further clarification.
Add cm3 as a synonym of mL C28254                                      Send to CDISC for review.


Would you please add OTHER as an allowable value for the
EGSTRESC variable within the ECG Result Codelist contained
within the SDTM Terminology spreadsheet? By doing this, it will
enable an easier record linking capability between the EG and
SUPPQUAL datasets.

CDISC rules for representing HYPO are to use HPO. Please      Agree; Send to CDISC for review
therefore consider change the new code to HPOCHROM instead of
                                                  Change    Implementation
              CDISC Decision
                                                   Type          Date

Agree                                        II            Q1 2009

Do not need anisocytosis                     II            Q1 2009




Agree                                        II            Q3 2009

Agree                                        II            Q2 2009




Agree                                        II            Q2 2009




Agree, lets use Standard Cubic Meter as the II             Pending
term and SCM (in all caps) as the synonym.




The term currently show as Poikilyocyte so I II            Q1 2009
am assuming that it will just be remapping
on your side with a new code. I am in
agreement



Agree                                        II            Q1 2009




Agree                                        II            Q1 2009




Agree                                        II            Q1 2009




Agree                                        II            Q1 2009


Agree                                        II            Q1 2009


Agree                                        II            Q1 2009
Agree                                        II   Q1 2009

Agree                                        II   Q1 2009


Agree.                                       II   Q1 2009




Agree                                        II   Q1 2009

Agree                                        II   Q1 2009


Agree                                        II   Q1 2009


Agree                                        II   Q1 2009




Agree                                        II   Q1 2009




Agree                                        II   Q2 2009

Agree                                        II   Q1 2009




Agree                                        II   Q1 2009




Agree                                       II    Q2 2009
Do not agree. The AESEV codelist comes      III   Denied
from ICH E2A. It has the three code choices
of MILD, MODERATE, SEVERE and is used
with the variable AESEV. The terminology
team has determined that the AESEV
codelist is not extensible. The TOXGR
codelist has the choices requested and is
used with the variable AETOXGR. Use the
TOXGR codelist and AETOXGR variable
instead of AESEV.
The CDISC team does not agree to           III   Denied
implement this request to add an addtional
term to the NCOMPLT. You could put
"SUBJECT REFUSED STUDY TREATMENT
" in DSTERM and map it to "NON-
COMPLIANCE WITH STUDY DRUG" for
DSDECOD or you can keep the term as a
Centocor specific term for DSDECOD since
the code list is extensible




This request has been withdrawn by the      II   Removed from
submitter.                                       Request List.




Agree                                       II   Q3 2009


Agree                                       II   Q1 2009

Agree                                       II   Q1 2009


Agree                                       II   Q2 2009
Agree                                       II   Q2 2009

Agree                                       II   Q2 2009

Agree                                       II   Q2 2009

Agree                                       II   Q2 2009

Agree                                       II   Q1 2009
Agree   II    Q1 2009

Agree   II    Q1 2009


Agree   II    Q1 2009


Agree   II    Q1 2009




Agree   II    Q1 2009

        III   Q4 2009




Agree   II    Q1 2009




Agree   II    Q2 2009


Agree   II    Q2 2009




Agree   II    Q1 2009

Agree   II    Q1 2009

Agree   II    Q1 2009


Agree   II    Q1 2009


Agree   II    Q1 2009


Agree   II    Q1 2009

Agree   II    Q1 2009

Agree   II    Q1 2009


Agree   II    Q1 2009
Agree                                             II   Q1 2009




Agree                                             II   Q2 2009




Use this text: The loss or lack of                II   Q2 2009
continuation of a subject to follow-up.




Use this text: A type of adverse event that       II   Q2 2009
interrupts usual activities of daily living, or
significantly affects clinical status, or may
require intensive therapeutic intervention.




Agree                                             II   Q1 2009

Agree                                             II   Q1 2009

Agree                                             II   Q2 2009

Agree                                             II   Q2 2009

Agree                                             II   Q2 2009


Agree                                             II   Q1 2009

Agree                                             II   Q1 2009


Agree                                             I    Q1 2009
Agree                                             II   Q2 2009


Agree                                             II   Q2 2009
Agree                                             II   Q2 2009

Agree                                             II   Q1 2009


Agree                                             II   Q1 2009
Use this text: The status of the subject's    II   Q2 2009
completion of the study or a segment of the
study, or the reason the subject
discontinued the study or segment of the
study.




Agreed with Lab Terminology Team 2009-03- II       Q2 2009
13 to change Somatotropin to
Somatotrophin. Remove the duplicate term
Growth Hormone. Growth Hormone would
be the synonym. Use the name SOMATRO.
Do not add Somatotropin as a new term.




Agree                                         II   Q1 2009

Chris says: There is already a request in to II    Q1 2009
removed ratio for the two: C74761 ID 11854
and C74753 ID 19124. I will check with Phil
on the other one. Phil says: I am fine
removing the "ratio" phrase for
Allbumin/Creatinine.
Agree                                         II   Q4 2009




Agree                                         II   Q2 2009


Agree                                         II   Q4 2009




Agree                                         II   Q1 2009
 1 needs further discussion. Will take to the   II    Pending
Term/Gov/Imp team. No changes currently.
Since SDTM is an unbrella doc for SEND
and human clinical trial we will leave as is
temporarily. 2 agree to sorting
alphabetically




Lab terminology team decided to add this        III   Q4 2009
term to package 4. Add Indican to General
Chemist list. PT Indican, INDICAN. Def: A
measurement of the Indican in a urine
specimen.




New Def: A measurement of the cells            II     Q3 2009
containing Pappenheimer Bodies (violet or
blue staining, ferritin granules usually found
along the periphery of the red blood cells) in
a biological specimen.




1) New SYs: Leukemic Blasts, Leukemic     II          Q3 2009
Lymphoblasts, Immunoblastic Lymphocytes;
2) Previously agreed to; 3) Remove C74767
from CT spreadsheet
Agree to add with NCI definition              III   Q3 2009




Agree to add QD with 'Daily' as a synonym.    III   Q3 2009




Agree                                         I     Q2 2009




Agree                                         II    Q3 2009


On list for development with Package 4. Will III    Q4 2009
be published at end of year with P4

On list for development with Package 4. Will III    Q4 2009
be published at end of year with P4

Agree                                         II    Q3 2009




Agree                                         I     Q3 2009




Agree                                         I     Q3 2009




Agree                                         I     Q3 2009


Agree                                         I     Q3 2009




Agree                                         I     Q3 2009


Agree                                         I     Q3 2009




Will be added with Pkg 4 development          III   Q4 2009


Will be added with Pkg 4 development          III   Q4 2009
Will not be added. OBJSEC goes into           III   Denied
TSPARMCD. See request 20856. Will not
implement this request.
Will be added with Pkg 4 development          III   Q4 2009


Will be added with Pkg 4 development          III   Q4 2009




Will be added with Pkg 4 development          III   Q4 2009


Will be added with Pkg 4 development          III   Q4 2009


I am in agreement with all term except "QTC III     Q3 2009
Prolongation > 500 msec". We had huge
debates over 500 vs 550. If we can get
mutiple MDs in the US, EU and Japan to
agree on 500 then I have no problem with
that number. Could we just use "QTC
Prolongation"?




A group of terminology/SDS team experts       II    Denied
have decided not to add semi-supine. The
term is imprecise and we have found a
couple of different definitions. The nurses
and MD are used to seeing 'semi-fowler' in
orders.

Agree                                         I     Q2 2009

Agree however this is a CDISC Glossary        I     Denied. This is a
Definition and should not be altered by             CDISC-Glossary
SDTM.                                               Definition.

Agree however this is a FDA Definition and    I     Denied. This is an
should not be altered by SDTM.                      FDA Definition.

Agree                                         I     Q2 2009

Agree however this is a FDA Definition and    I     Denied. This is an
should not be altered by SDTM.                      FDA Definition.
Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

Agree                                           I     Q2 2009

There are 2 entries for fine granular casts-    I     Q3 2009
C74767 and C74769. Delete C74767 - this
one is not correct

We have tried to move away from 2 letter        II    Denied
codes to avoid confusion with 2 letter codes
used for abbrebiations. Will leave
LACTICAC as the code.
Our decision is not to add any timing           III   Denied
qualifiers to the urine protein test. If we add
a code for 24 hour, then we open the door to
add 12 hour, and many others. We will not
make this change.




A group of terminology/SDS team experts         III   Denied
have decided not to add "Dose Delayed" to
the action code list because this distinction
is not necessary in the AE database. It
would be difficult to know when to use one
versus the other. The information about
dose delays would probably be best
captured with exposure information.

Agree to fix the typo                           I     Q2 2009
Agree to change SYs.                            I     Q3 2009




Will consider with the next lab term release. III     Q4 2009
Will be added with Lab P4 at end of Year.




Will add to lab P4. Add D-Dimer (DDIMER)        III   Q4 2009
as a LBTEST (LBTESTCD) term. Close out
request.




Add a synonym for all terms with microgram II         Q3 2009
(ug) that includes mcg in place of ug.Yes, I
found the same ones - do we want to
change ukat/L to mcgkat/L? Is this
commonly found? EM-Yes, See public
review change request file for final list of all
terms to be changed.

Will not add to vital signs. This would be in a III   Q1 2010
specialized domain.
Will add to Lab P4. Partial pressure of         III   Q4 2009
carbon dioxide (PaCO2). This measures
how much carbon dioxide is dissolved in the
blood and how well carbon dioxide is able to
move out of the body. -fdong. Close out
request

Will add in ab P4. Partial pressure of oxygen III     Q4 2009
(PaO2). This measures the pressure of
oxygen dissolved in the blood and how well
oxygen is able to move from the airspace of
the lungs into the blood. -fdong. Close out
Request
Add to CDISC Country Codelist               III   Q3 2009




Add Grade 0 to CATCAE v4 LBTOXGR            III   Q4 2009
codelist




Add to Units codelist                       III   Q4 2009




Agree to add to Q1 2010 package.            III   Q4 2009

Will be added with P4 General Terminology. III    Q4 2009
Close out Request
Will be added with P4 General Terminology. III   Q4 2009
Close out Request




Will be added with P4 General Terminology. III   Q4 2009
Close out Request




Will be added with P4 General Terminology. III   Q4 2009
Close out Request




Will be added with P4 General Terminology. III   Q4 2009
Close out Request




Will be added with P4 General Terminology. III   Denied
Close out Request. 2009-09-01: This term
will not be added. The term Trial Primary
Objective should be used to allow for all the
data to be in one place.

Terms should match CTCAE. Agree to      III      Q4 2009
change and add Grade 0 to CDISC v4
CTCAE LBTOXGR codelist. The v3 CTCAE
LBTOXGR codelist will remain intact for
now. See Erin document for final defs.




Agree to add to Q1 2010 package.            II   Q4 2009
The SDTM concept of MULTIPLE is a              III    Denied
concept within the rules, not really a concept
within the terms as such. It is inappropriate
to add the word "MULTIPLE" to a codelist
simply to expediate a SDTM rule. There is
no such thing as a Severity called
MULTIPLE. Therefore MULTIPLE will not be
added.

The information about decreasing the            III   Denied
infusion rate belongs on the exposure (EX)
domain. If there is an associated AE then
the action taken would be "DOSE NOT
CHANGED'. This has been confirmed with
the SDS oncology team.

CDISC agrees to NCI suggestions.                I     Q3 2009




CDISC is deciding not to add. This maps to      III   Q4 2009
to Bilirubin Measurement




Change code.                                    I     Q3 2009
CDISC decision is not to add this new code. III       Denied
This is not how many times per day, but
when. This is a dose regimen and could go
into the planned dose regimen. We have
previously agreed not to add "at lunch", "at
bedtime", etc and this request is similar.



CDISC has decided not to add this code.         III   Denied
The current codes come from E2B and as
far as we know they have not changed. If
you have a reference that the E2B codes
have changed, please provide that
reference.




CDISC decides to keep the C-code as is          III   Q1 2010
and change the definition to: A groove on
the surface of the liver.

This request will be included in the next lab   III   Q1 2010
terminology package FY2010.




This request will be included in the next lab   III   Q1 2010
terminology package FY2010.
This request will be included in the next lab   III   Q1 2010
terminology package FY2010.
Decision: mL is already in the list will add    II    Q1 2010
cm3 as a synonym for code C28254.

Need more SDS Team discussion                   III   Pending




Agree                                           II    Q3 2009
                                                                    New Term or Codelist/Existing
 Status    Date of Submission   Request Code     Submitter Name
                                                                       Term or Code Number

Open      1/11/2010 14:00       25639          Allen, Laura       Anti-Single Stranded DNA


Open      1/11/2010 14:03       25640          Allen, Laura       ASSDNA




Open      1/11/2010 14:05       25641          Allen, Laura       Influenza A Virus PCR




Open      1/11/2010 14:07       25642          Allen, Laura       INFAPCR




Open      1/13/2010 16:24       25750          Omundsen, Erica    Bone Specific Alkaline
                                                                  Phosphatase




Open      1/20/2010 12:06       25942          Facile, Rhonda     Anatomical Location/Blood
                                                                  Pressure/ ANKLE




Open      1/20/2010 13:19       25943          Allen, Laura       Type I Myeloblasts


Open      1/20/2010 14:58       25948          Allen, Laura       Add SDTM - LBTESTCD of
                                                                  BLSTMY1




Open      1/20/2010 15:09       25950          Allen, Laura       Type II Myeloblasts




Open      1/20/2010 15:16       25952          Allen, Laura       BLSTMY2




Open      1/20/2010 15:20       25953          Allen, Laura       Type III Myeloblasts




Open      1/20/2010 15:24       25954          Allen, Laura       BLSTMY3




Open      1/20/2010 15:28       25955          Allen, Laura       Myeloid/Erythroid Ratio
Open   1/20/2010 15:31   25956   Allen, Laura   MERATIO




Open   1/21/2010 12:02   25999   Allen, Laura   Chlamydia Pneumoniae IgM
                                                Antibody




Open   1/21/2010 13:01   26005   Allen, Laura   CPIGMAB




Open   1/21/2010 13:05   26006   Allen, Laura   Legionella Pneumophila IgG
                                                Antibody




Open   1/21/2010 13:08   26007   Allen, Laura   LPIGGAB




Open   1/21/2010 13:12   26009   Allen, Laura   Legionella Pneumophila IgM
                                                Antibody




Open   1/21/2010 13:25   26013   Allen, Laura   LPIGMAB




Open   1/21/2010 13:28   26014   Allen, Laura   Legionella Pneumophila IgG and
                                                IgM Ab




Open   1/21/2010 13:35   26016   Allen, Laura   LPIGGMAB
Open   1/21/2010 15:05   26018   ONeill, Debra   Antimyeloperoxidase Antibody




Open   1/21/2010 15:08   26019   ONeill, Debra   Addition of test code 'ANTIMPAB'
                                                 to go with new term request
                                                 'Antimyeloperoxidase Antibody'


Open   1/26/2010 12:03   26119   ONeill, Debra   Acetylcholine
Open     2/1/2010 14:36    26291   Lenzen, Mary      SKINCLAS (C76351)




Closed   2/4/2010 4:28     26342   Wilden, Holger    C66790, there should only be one
                                                     codelist name for this codelist




Open     2/5/2010 11:54    26382   Campain-Teulon    ECG RESULT
                                   Elis




Open     2/17/2010 18:59   26544   Omundsen, Erica   Bone Specific Alkaline
                                                     Phosphatase
Open     2/22/2010 16:00   26620   ONeill, Debra    D-Dimer




Open     2/22/2010 16:02   26621   ONeill, Debra    DDIMER


Open     2/26/2010 3:16    26742   Not Provided     Acetoacetate or Acetoacetic acid




Closed   3/12/2010 10:10   27067   Erin Muhlbradt   Remove the word 'SPECIES' from
                                                    all genus-level CDISC PTs




Open     3/12/2010 10:11   27068   Erin Muhlbradt   Change NCI C-code of CDISC PT
                                                    GRAM-POSITIVE BACILLUS
                                                    from C86423 to C62589

Open     3/12/2010 10:12   27070   Erin Muhlbradt   Remove Mycobacterium fortuitum
                                                    subsp. fortuitum as a synonym of
                                                    Mycobacterium fortuitum C86538

Open     3/15/2010 11:17   27125   Pemble, Nik      EPISQTCE and Squamous
                                                    Transitional Epithelial Cells




Open     3/16/2010 19:39   27186   Allen, Laura     Hepatitis G RNA




Open     3/16/2010 19:45   27188   Allen, Laura     HGVRNA
Open   3/16/2010 19:49   27189   Allen, Laura     Influenza A Virus H1N1 PCR




Open   3/16/2010 19:52   27190   Allen, Laura     INFAH1N1




Open   3/17/2010 11:20   27221   Mary Lenzen      2 terms for TSPARMCD/TSPARM
                                                  that seem to be exactly the same -
                                                  CURTRT (Current Treatment) and
                                                  EXISTRT (Existing Treatment).
                                                  Please delete CURTRT




Open   3/17/2010 13:31   27229   Allen, Laura     Mycobacterium Tuberculosis QFT




Open   3/17/2010 13:34   27230   Allen, Laura     MTUBEQFT




Open   3/19/2010 13:34   27336   Allen, Laura     Chlamydia Pneumoniae IgA and
                                                  IgG Ab

Open   3/19/2010 13:39   27337   Allen, Laura     CPIGAGAB


Open   4/19/2010         28246   Linda Pedersen   Vascular Epithelial Growth Factor
                                                  please correct to the most
                                                  common test name Vascular
                                                  Endothelial Growth Factor

Open   4/26/2010         28340   Tobias Hermes    "FASTING BLOOD GLUCOSE
                                                  (SST)"

Open   4/26/2010         28341   Tobias Hermes    "Crystals: Amorphous
                                                  phosphates", "Crystals:
                                                  Amorphous urates" and "Crystals:
                                                  Amorphous debris"
Open   4/26/2010         28342   Tobias Hermes      "Erythrocytes; Red Blood Cells in
                                                    Urine" and "Leukocytes; White
                                                    Blood Cells in Urine"

Open   4/26/2010         28343   Tobias Hermes      "Bilirubin in Urine" and "Blood in
                                                    Urine"

Open   5/24/2010 17:32   28658                      C74724, c74725, c74726,
                                                    c74727 HAVPCR, HBVPCR,
                                                    HCVPCR, HIVPCR - remove
                                 Chris Tolk         PCR, this is a method
Open   5/26/2010 11:45   28691                      C54431 add synonym of
                                 Chris Tolk         microalbumin to albumin
Open   5/27/2010 13:10   28705

                                                    C49610 C66734
                                                    Domain Abbreviation SC
                                                    Subject Characteristics The
                                                    subject characteristics domain
                                                    is for data not collected in
                                                    other domains that is subject-
                                                    related. Examples: subject
                                 Dirk Van           initials, other race details, eye
                                 Krunckelsven       color, childbeari
Open   6/4/2010 19:17    28792




                                 Anna Pron-Zwick    Nasopharyngeal
Open   6/12/2010 19:39   28862

                                 Estrelita Janse van
                                 Rensburg            Hepatits C virus antibodies
Open   6/12/2010 19:41   28863



                                 Sophia Paterakis   OCCASIONAL
Open   6/18/2010 11:46   28927




                                 Dianne
                                 Weatherall    TABLET, OVER ENCAPSULATED
Open   6/21/2010 19:27   28937
                                               Add new term DOSE
                                 Dianne        ADJUSTED or allow the
                                 Weatherall    codelist to be extensible
Open   6/25/2010 13:13   28983
                                               AMA Antimitochondrial
                                 Claire West   Antibodies
Open   6/25/2010 13:14   28984                 BNPPRO ProB-type Natriuretic
                                 Claire West   Peptide
Open   6/25/2010 13:16   28985




                                 Claire West   CTOT Complement Total
Open   6/25/2010 13:17   28986
                                                  CTXI Type I Collagen C-
                                 Claire West      Telopeptides
Open   6/25/2010 13:18   28987

                                                  HTPHAB Heterophile
                                 Claire West      Antibodies
Open   6/25/2010 13:20   28988




                                                  VCAM1 Vascular Cell Adhesion
                                 Claire West      Molecule 1
Open   6/25/2010 13:21   28989

                                 Claire West      PO2 Partial Pressure Oxygen
Open   6/25/2010 13:22   28990



                                 Claire West      VITD Vitamin D
Open   6/25/2010 13:24   28991




                                 Claire West      IGG Immunoglobulin G
Open   6/25/2010 13:25   28992



                                                  FDP Fibrin Degradation
                                 Claire West      Products
Open   7/8/2010 18:55    29070
                                                  LBTESTCD=PT
                                                  LBTEST=Prothrombin Time.
                                                  The team should reconsider
                                                  the definition. Currently it
                                                  indicates that it can be
                                                  expressed in units of time or
                                                  percentage activity. We can
                                                  only have one unit type per
                                 Nik Pemble       test code.
Open   7/9/2010 14:06    29077                    C85659 Liter per Gram per
                                                  Minute; remove synonym
                                 Erin Muhlbradt   uL/ug/s
Open   7/9/2010 14:31    29078
                                 Erin Muhlbradt   C85663 L/kg/day
Open   7/16/2010 13:02   29140

                                                  Remove C85713 mL/g/s from
                                 Erin Muhlbradt   PKUNIT codelist
Open   8/2/2010 17:37    29241


                                                  Modify explanation of NCIt PT
                                                  column on
                                                  SDTM/CDASH/ADaM
                                 Erin Muhlbradt   spreadsheets in ReadMe tab
Open   9/8/2010 12:16    29614




                                                  SC codelist (Subject
                                 Manuel Horas     Characteristics)
Open   9/20/2010 11:36   29697   Tore Haglund     Code C77666 = EMESIS should
                                                  be VOMIT




Open   9/20/2010 14:19   29698   Manuel Horas     /h
Open   9/21/2010 12:13   29708   Claire West   Code: 1 ; Label: Proportion of
                                               1



Open   9/21/2010 12:13   29709   Claire West   Code: %TL CK; Label:
                                               Percentage of total creatine
                                               kinase



Open   9/21/2010 12:14   29710   Claire West   Code: CELLS/HPF; Label: Cells
                                               per high power field




Open   9/21/2010 12:15   29711   Claire West   Code: CELLS/F; Label: Cells per
                                               field

Open   9/21/2010 12:16   29712   Claire West   Code: TITER/TITRE; Label:
                                               Titer/Titre
Open   9/21/2010 12:17   29713   Claire West   Code: %O; Label: Promille (per
                                               1000 RBC)
Open   9/22/2010 12:55   29726   Claire West   Code: EIA; Label: Enzyme
                                               Immunoassay Value
Open   9/22/2010 12:56   29727   Claire West   Code: EU/dL; Label: Ehrlich
                                               units per decilitre
Open   9/22/2010 13:25   29728   Claire West   Is there a principle about
                                               coding non-unit words. These
                                               include the following:
                                               ACTUATION
Open   9/22/2010 13:26   29729   Claire West   Code: um3; Label: Cubic
                                               micrometre
Open   9/22/2010 13:27   29730   Claire West   Code: fl; Label: Femtolitre

Open   9/22/2010 13:34   29731   Claire West   I have 3 codes that make use
                                               of the term Femtomole...

Open   9/22/2010 13:36   29732   Claire West   g% - Grams percent; mg% -
                                               Miligrams percent
Open   9/22/2010 13:38   29733   Claire West   Code: mg/mg creat; Label:
                                               Milligrams per gram of
                                               Creatinine
Open   9/22/2010 13:39   29734   Claire West   Can you please review and
                                               comment on the following
                                               synonym suggestions:
Open   9/22/2010 13:40   29735   Claire West   Can you please confirm the
                                               use of k vs thousand.
Open   9/22/2010 13:42   29736   Claire West   We use GI/L (giga/Litre) and
                                               TI/L (Tera/Litre) a lot. Should
                                               these codes remain GI/L and
                                               TI/L or be expanded to Giga/L
                                               and Tera/L?

Open   9/22/2010 13:43   29737   Claire West   In the UNIT terminology for
                                               the unit ug/m3, the definition
                                               refers to synonyms. Can these
                                               please be added to the
                                               Synonym column? i.e. ng/L
                                               and pg/mL

Open   9/22/2010 13:44   29738   Claire West   Case is a constant question
                                               e.g. FEU (Fibrinogen
                                               equivalent units) I assume
                                               this should be uppercase
                                               based on CFU (Colony
                                               Forming Units)?

Open   9/22/2010 13:52   29739   Claire West   Can I use MESF as an industry
                                               abbreviation for molecules of
                                               equivalent soluble
                                               fluorochromes? e.g. MESF/cell
                                               (or CELL)?
Open   9/22/2010 13:53   29740   Claire West   I have a unit of Median
                                               Fluorescence. Should I use
                                               MFI or spell the unit in its
                                               entirety in lowercase?
Open   9/22/2010 13:54   29741   Claire West   I have a code of CTC/7.5mL.

Open   9/22/2010 13:54   29742   Claire West   Would circulating endothelial
                                               cells be expressed as CEC
                                               since this appears to be an
                                               industry std abbreviation
Open   9/22/2010 15:10   29743   Van Krunckelsven Actually a mixture between
                                 Dirk             new term request and modify
                                                  term request...




Open   9/29/2010 16:32   29805   Hector Robertson Not Sure

Open   10/1/2010 12:03   29816   Matthew Peck     Treatment Adjusted




Open   10/1/2010 12:58   29817   Nik Pemble       The lab test name associated
                                                  with VEGF I think is not
                                                  correct. It currently reads
                                                  VASCULAR EPITHELIAL
                                                  GROWTH FACTOR and I think
                                                  it should read VASCULAR
                                                  ENDOTHELIAL GROWTH
                                                  FACTOR

Open   10/13/2010 16:34 29895    Audrey Walker    C42576 C71620 Unit kg/m3


Open   10/13/2010 17:05 29898    Audrey Walker    C64572 C71620 Unit g/m3




Open   10/13/2010 17:06 29899    Audrey Walker    C67255 C77528 UNIT
                                                  thous/uL

Open   10/13/2010 17:07 29900    Audrey Walker    C67308 C77528 UNIT
                                                  mill/uL million per microliter
Open   10/14/2010 12:10 29904    Audrey Walker    C67327 C71620 Unit ug/m3




Open   10/14/2010 18:26 29912    Monica Mattson   Current codelist value
                                                  WITHDRAWAL BY SUBJECT.
                                                  Suggest enhance to
                                                  WITHDRAWAL OF INFORMED
                                                  CONSENT BY SUBJECT to avoid
                                                  possible confusion if subject
                                                  withdraws , for example, from
                                                  one phase of the study
                                                  (treatment phase) but allows
                                                  data collection for follow-


Open   10/22/2010 12:48 29960    Carol Vaughn     Change terms to sentence
                                                  case




Open   10/27/2010 17:06 30005    Chris Tolk       Change C20587 from Age
                                                  Group to Age Span to match
                                                  the text in C67152 and Age
                                                  Span code list.
Open   11/2/2010 12:13   30055   Albert Chau      Platelet should be changed to
                                                  Platelets

Open   11/5/2010 14:06   30081   claire west      10^3/uL
Open   11/8/2010 13:18   30096   Gail Stoner      EPISQCE




Open   11/8/2010 14:00   30098   Erin Muhlbradt   CDASH Terminology - C78424
                                                  codelist code
Open   11/10/2010 14:11 30117    Monica Mattson   In SDTM-PKPARM: Request
                                                  addition of AUC Infinity Obs
                                                  Norm by Dose to allow for
                                                  dose-normalization of AUC
                                                  extrapolated to infinity.

Open   11/19/2010 13:52 30166    Chris Tolk       C25298 C66741 Vital Signs
                                                  Test Code SYSBP Systolic
                                                  Blood Should read 'Systolic
                                                  Blood Pressure'
Open   11/24/2010 18:25 30217    Erin Muhlbradt   Changes to ADaM
                                                  Terminology spreadsheet
Open   11/24/2010 18:28 30218    Erin Muhlbradt    Changes to existing CDASH CT
                                                   Spreadsheet format




Open   12/6/2010 20:03   30274   Anna Pron-Zwick   Cardiovascular System;
                                                   Endocrine System; Exocrine
                                                   System; Immune System;
                                                   Hematopoietic and Lymphatic
                                                   System; Musculoskeletal
                                                   System; Nervous System;
                                                   Respiratory System;
                                                   Integumentary System;
                                                   Reproductive System

Open   12/10/2010 13:27 30302    campain-teulon    CEREBRAL CORTICAL;
                                                   CEREBRAL SUBCORTICAL;
                                                   BRAINSTEM

Open   12/10/2010 13:29 30303    Randall Austin    modify CDISC definition where
                                                   TSPARM=Planned number of
                                                   subjects and
                                                   TSPARMCD=PLANSUB




Open   12/21/2010 13:21 30358    John Swithenbank QHS - Every Night; MANE - In
                                                  the Morning; NOCTE - At night
Open   12/21/2010 13:22 30359   John Swithenbank Kappa Free Light Chain;
                                                 Lambda Free Light Chain; Free
                                                 Kappa/Free Lambda Ratio; M-
                                                 Protein; Quantitative
                                                 immunoglobulins and IgG,
                                                 IgM, IgA, IgD

Open   12/21/2010 13:26 30360   John Swithenbank 21 days with 7 day break



Open   12/21/2010 13:27 30361   John Swithenbank LBTEST = Immunoglobulin D;
                                                 LBTESTCD = IGD
          Justification               Summary                         Detailed Description

This concept is not in the      addition of new term   addition of new term
dictionary.

                                Addition of new test   Addition of new test code for Anti-Single Stranded
                                code for Anti-Single   DNA
                                Stranded DNA

This concept is not in the      Addition of new term Addition of new term.
dictionary.


This concept is not int he      Addition of new test   Addition of new test code for Influenza A Virus
dictionary.                     code for Influenza A   PCR.
                                Virus PCR

I do not see a code and         Bone Specific        New code is needed for new term Bone Specific
decode for Bone Specific        Alkaline Phosphatase Alkaline Phosphatase
Alkaline Phosphatase.


The code list is anatomical     Add ANKLE as a         See summary.
location. So the measurement    location for taking
would be blood pressure and     blood pressure.
the anatomical location would
be ankle.

The lab term 'Type I            Add a new SDTM -     Add a new SDTM - LBTEST of Type I Myeloblasts
Myeloblasts' is not in the      LBTEST of Type I
CDISC lab tests dictionary.     Myeloblasts
The SDTM - LBTESTCD of          Add a SDTM -         Add a SDTM - LBTESTCD of BLSTMY1 for the
BLSTMY1 is not in the CDISC     LBTESTCD of          test 'Type I Myeloblasts'
lab tests dictionary.           BLSTMY1 for the test
                                'Type I Myeloblasts'

The lab term (LBTEST) of Type Add a new SDTM -         Add a new SDTM - LBTEST of Type II
II Myeloblasts is not in the  LBTEST of Type II        Myeloblasts
CDISC lab tests dictionary.   Myeloblasts

The LBTESTCD of BLSTMY2         Add a new SDTM -       Add a new SDTM - LBTESTCD of BLSTMY2 for
is not in the CDISC lab tests   LBTESTCD of            Type II Myeloblasts
dictionary.                     BLSTMY2 for Type II
                                Myeloblasts
Justification for Change        Add a new SDTM -       Add a new SDTM - LBTEST of Type III
Request: The lab term           LBTEST of Type III     Myeloblasts
(LBTEST) of Type III            Myeloblasts
Myeloblasts is not in the
CDISC lab tests dictionary.
The lab test code (LBTESTCD) Add a new SDTM -          Add a new SDTM - LBTESTCD of BLSTMY3 for
of BLSTMY3 is not in the       LBTESTCD of             Type III Myeloblasts
CDISC lab tests dictionary.    BLSTMY3 for Type III
                               Myeloblasts
The lab term (LBTEST) of       Add a new SDTM -        Add a new SDTM - LBTEST of Myeloid/Erythroid
Myeloid/Erythroid Ratio is not LBTEST of               Ratio
in the CDISC lab test          Myeloid/Erythroid
dictionary.                    Ratio
The lab test code (LBTESTCD) Add a new SDTM -      Add a new SDTM - LBTESTCD of MERATIO for
of MERATIO is not in the     LBTESTCD of           Myeloid/Erythroid Ratio
CDISC lab test dictionary.   MERATIO for
                             Myeloid/Erythroid
                             Ratio
The lab term (LBTEST) of     Add a new SDTM-       Add a new SDTM-LBTEST of Chlamydia
Chlamydia Pneumoniae IgM     LBTEST of             Pneumoniae IgM Antibody. Reference:
Antibodyis not in teh CDISC  Chlamydia             http://www.aruplab.com/
dictionary.                  Pneumoniae IgM
                             Antibody
The lab test code (LBTESTCD) Add a new SDTM-       Add a new SDTM-LBTESTCD of CPIGMAB for
of CPIGMAB is not int eh     LBTESTCD of           Chlamydia Pneumoniae IgM Antibody.
CDSIC dictionary.            CPIGMAB for
                             Chlamydia
                             Pneumoniae IgM
                             Antibody
The lab term (LBTEST) of     Add a new SDTM-       Add a new SDTM-LBTEST of Legionella
Legionella Pneumophila IgG   LBTEST of             Pneumophila IgG Antibody.
Antibody is not in the CDISC Legionella
dictionary.                  Pneumophila IgG
                             Antibody
The lab test code (LBTESTCD) Add a new SDTM -      Add a new SDTM - LBTESTCD of LPIGGAB for
of LPIGGAB is not in the     LBTESTCD of           Legionella Pneumophila IgG Antibody
CDSIC dictionary.            LPIGGAB for
                             Legionella
                             Pneumophila IgG
                             Antibody
The lab term (LBTEST) of     Add a new SDTM-       Add a new SDTM-LBTEST of Legionella
Legionella Pneumophila IgM   LBTEST of             Pneumophila IgM Antibody. Reference:
Antibody is not in the CDISC Legionella            http://www.questdiagnostics.com/hcp/qtim/testMe
dictionary.                  Pneumophila IgM       nuSearch.do
                             Antibody
The lab test code (LBTESTCD) Add a new SDTM -      Add a new SDTM - LBTESTCD of LPIGMAB for
of LPIGMAB is not in the     LBTESTCD of           Legionella Pneumophila IgM Antibody
CDSIC dictionary.            LPIGMAB for
                             Legionella
                             Pneumophila IgM
                             Antibody
Justification for Change     Add a new SDTM-       Add a new SDTM-LBTEST of Legionella
Request: The lab term        LBTEST of             Pneumophila IgG and IgM Ab. Reference:
(LBTEST) is not in the CDISC Legionella            http://www.questdiagnostics.com/hcp/qtim/testMe
dictionary.                  Pneumophila IgG and   nuSearch.do
                             IgM Ab
The lab test code of         Add a new SDTM -      Add a new SDTM - LBTESTCD of LPIGGMAB for
LPIGGMAB is not in the CDISC LBTESTCD of           Legionella Pneumophila IgG and IgM Ab
dictionary.                  LPIGGMAB for
                             Legionella
                             Pneumophila IgG and
                             IgM Ab
The lab term                   Addition of term       The term 'Antimyeloperoxidase Antibody' is not
'Antimyeloperoxidase Antibody' 'Antimyeloperoxidase   currently available in SDTM-LBTEST.
is not currently available in  Antibody' to LBTEST    "Antineutrophil cytoplasmic antibodies (ANCA)
SDTM-LBTEST.                                          are autoantibodies directed against lysosomal
                                                      enzymes of human neutrophils and monocytes.
                                                      Myeloperoxidase (MPO) is the autoantigen most
                                                      commonly responsible for ANCA reactivity that
                                                      demonstrates the perinuclear pattern (P-ANCA)."
                                                      Speciality Laboratories "Antineutrophil
                                                      Cytoplasmic Autoantibodies" - see attached file.
                                                      This test is available for testing from: ARUP
                                                      Laboratories
                                                      (http://www.aruplab.com/guides/ug/tests/2002068.
                                                      jsp); Mayo Medical Laboratory
                                                      (http://www.mayomedicallaboratories.com/test-
                                                      catalog/Overview/80389); Quest Diagnostics
                                                      (http://www.questdiagnostics.com/hcp/testmenu/js
                                                      p/showTestMenu.jsp?fn=70159X.html&labCode=
                                                      SJC); Speciality Laboratories
                                                      (http://www.specialtylabs.com/tests/details.asp?id
                                                      =1866)



Addition of test code          Addition of            Addition of test code 'ANTIMPAB' to go with the
'ANTIMPAB' to go with the      'ANTIMPAB' to          request to add the new term 'Antimyeloperoxidase
request to add the new term    LBTESTCD               Antibody'
'Antimyeloperoxidase Antibody'

Addition of a synonym(s) for
the term Acetylcholine for
clarification
Below is a reference for the         Fitzpatrick            Below is a reference for the Fitzpatrick
Fitzpatrick Classification           Classification Scale   Classification SCale. Based on that, I expected
SCale. Based on that, I              does not match with    the SKINCLAS (C76351) CDISC Submission
expected the SKINCLAS                CDISC controlled       Value to be I, II etc and not TYPE1, TYPE2 etc.
(C76351) CDISC Submission            terminology            http://dermatology.about.com/od/cosmeticprocedu
Value to be I, II etc and not                               re/a/fitzpatrick.htm: Fitzpatrick Classification
TYPE1, TYPE2 etc.                                           Scale: Skin Type Skin Color Characteristics: I
http://dermatology.about.com/o                              White; very fair; red or blond hair; blue eyes;
d/cosmeticprocedure/a/fitzpatri                             freckles Always burns, never tans; II White; fair;
ck.htm: Fitzpatrick                                         red or blond hair; blue, hazel, or green eyes
Classification Scale: Skin Type                             Usually burns, tans with difficulty; III Cream white;
Skin Color Characteristics: I                               fair with any eye or hair color; very common
White; very fair; red or blond                              Sometimes mild burn, gradually tans; IV Brown;
hair; blue eyes; freckles Always                            typical Mediterranean caucasian skin Rarely
burns, never tans; II White; fair;                          burns, tans with ease; V Dark Brown; mid-eastern
red or blond hair; blue, hazel,                             skin types very rarely burns, tans very easily
or green eyes Usually burns,
tans with difficulty; III Cream
white; fair with any eye or hair
color; very common
Sometimes mild burn,
gradually tans; IV Brown;
typical Mediterranean
caucasian skin Rarely burns,
tans with ease; V Dark Brown;
mid-eastern skin types very
rarely burns, tans very easily;
VI Black Never burns, tans
very easily




In the SDTM Terminology 2009-
10-06 there are two codelist
names for this codelist, "Ethnic
Group" and "Patient Ethnic
Group".

New codes were requested by Request for new ECG EARLY R WAVE PROGRESSION; RSR‟ OR QR
ECG vendor to code          results codes       PATTERN IN V1 SUGGESTS RIGHT
abnormalities                                   VENTRICULAR DELAY; ELECTRONIC
                                                VENTRICULAR PACEMAKER; ELECTRONIC
                                                ATRIAL PACEMAKER; 2ND DEGREE A-V
                                                BLOCK (MOBITZ I); 2ND DEGREE A-V BLOCK
                                                (MOBITZ II); QTcB or QTcF Borderline Prolonged

We are unable to locate the          new term needed in     This is a request to have a new term added to the
corresponding term in either         SDTM-LBTEST and        SDTM-LBTEST and SDTM-LBTESTCD CDISC
the SDTM-LBTESTCD or                 SDTM-LBTESTCD          Code Lists for the lab test "Bone Specific Alkaline
SDTM-LBTEST code lists for           CDISC Code Lists       Phosphatase".
Bone Specific Alkaline
Phosphatase.
Concept of D-Dimer not         Addition of 'D-Dimer' Please add the test 'D-Dimer' to the SDTM-
currently available in CDISC   to LBTEST             LBTEST CDISC code list. This test is used to
                                                     measure the cross-linked fibrin degradation
                                                     product, D-dimer, in a biological specimen.
                                                     References: ARUP:
                                                     http://www.aruplab.com/guides/ug/tests/0030057.j
                                                     sp; Quest:
                                                     http://www.questdiagnostics.com/hcp/testmenu/js
                                                     p/showTestMenu.jsp?fn=32466P.html&labCode=
                                                     SJC;
code addition (DDIMER) to go   Addition of 'DDIMER' Addition of the test code 'DDIMER' to go with the
with request to add new term   to LBTESTCD          request to add the new term 'D-Dimer'.
(D-Dimer)
Acetoacetate or Acetoacetic    Acetoacetate or      Acetoacetate or Acetoacetic acid is not a part of
acid is not a part of LBTEST   Acetoacetic acid is  LBTEST and LBTESTCD
and LBTESTCD                   not a part of LBTEST
                               and LBTESTCD



                                                     Placing the word SPECIES in the CDISC PTs of
                                                     these terms in the NCI Thesaurus directly
                                                     contradicts the CDISC definition. This
                                                     contradiction, besides being terminologically
                                                     incorrect, causes problems when exporting our
                                                     databases. We strongly recommend removing the
                                                     word 'SPECIES' from the Genus level terms in the
                                                     MICROORG codelist.

                                                     This is the correct mapping in our database.




                                                     This is not really a synonym but more of a parent-
                                                     child relationship


                                                     EPISQTCE - This test code and related test name
                                                     Squamous Transitional Epithelial Cells is an
                                                     incorrect use of terminology; transitional epithelial
                                                     cells are typically cells originating from the
                                                     bladder whereas cells from the external urethra
                                                     are typically coined squamous epithelial cells.
                                                     These cells have different appearances based
                                                     upon their origin. As an FYI Renal tubular cells
                                                     originate in the kidney and is the third general
                                                     group of epithelial cells found in urine



                                                     Add a new SDTM - LBTEST of Hepatitis G RNA.
                                                     The lab term (LBTEST) Hepatitis G RNA is not in
                                                     the CDISC dictionary. Add a new SDTM -
                                                     LBTEST of Hepatitis G RNA
                                                     Reference: Specialty Laboratories
                                                     Add a new SDTM - LBTESTCD of HGVRNA for
                                                     Hepatitis G RNA. The lab test code (LBTESTCD)
                                                     of HGVRNAis not in the CDISC dictionary. Add a
                                                     new SDTM - LBTESTCD of HGVRNA for Hepatitis
                                                     G RNA.
Add a new SDTM - LBTEST of Influenza A Virus
H1N1 PCR. The lab term (LBTEST) of Influenza A
Virus H1N1 PCR is not in the CDISC dictionary.
Add a new SDTM - LBTEST of Influenza A Virus
H1N1 PCR. Reference: Quest Diagnostics

Add a new SDTM - LBTESTCD of INFAH1N1 for
Influenza A Virus H1N1 PCR. The lab test code
(LBTESTCD) of INFAH1N1 is not in the CDISC
dictionary. Add a new SDTM - LBTESTCD of
INFAH1N1 for Influenza A Virus H1N1 PCR.

I submitted the request to add EXISTRT (Existing
Treatment) based on work done by the CDISC
Trail Design Team. Do not why or who requested
CURTRT but do not need both since they are
redundant.




This term is not in the CDISC Dictionary.
Definition: Identification of Mycobacterium
tuberculosis in a biological specimen using the
quantiFERON-TB Gold In Tube (QFT).
QuantiFERON-TB Gold In Tube is a Cell
Culture/Enzyme-Linked Immunosorbent assay
specific for Mycobacterium tuberculosis, not
nontuberculosis mycobacterium or the BCG
vaccine.
This term is not in the CDISC Dictionary.
Definition: Identification of Mycobacterium
tuberculosis in a biological specimen using the
quantiFERON-TB Gold In Tube (QFT).
QuantiFERON-TB Gold In Tube is a Cell
Culture/Enzyme-Linked Immunosorbent assay
specific for Mycobacterium tuberculosis, not
nontuberculosis mycobacterium or the BCG
vaccine.
The lab term (LBTEST) of Chlamydia
Pneumoniae IgA and IgG Ab is not in the CDISC
dictionary.
The lab code (LBTESTCD) of CPIGAGAB is not in
the CDISC dictionary.

When doing some research to add this LBTEST
to our own system we discovered that the most
common name is Vascular Endothelial Growth
Factor

Suggesting "FBG"


Suggesting "CYAMPHOS", "CYAMURAT" and
"CYAMDEBR"
Suggesting "URBC" and "UWBC"




Suggesting "UBILI" and "UBLOOD"


C74724, c74725, c74726, c74727 HAVPCR,
HBVPCR, HCVPCR, HIVPCR - remove PCR,
this is a method


C54431 add synonym of microalbumin to
albumin
The description, example part seems to not
accord with SDTM 3.1.2 where the race other
is now captured on SUPPDM (personally I
preffered SC for this as per SDTM IG 3.1.1,
but it seems to have changed).




Please consider either adding Nasopharynx
or Nasopharyngeal as a specimen type.
Nasopharyngeal swabs are frequently used
when testing for various viruses, e.g.
Adenovirus, Rhinovirus, Influenza, etc.

The list that I saw contained the following
name: Hepatitis C virus surface antibodies.
The term "surface" should be removed since
it is used with Hepatitis B virus.

 This FREQ term is actually in the SDTM IG
3.1.2. We include this frequency in our CRFs
(for SU cigarette smoking). Non of the
existing terms for FREQ actually cover this.
We have a trial where tablets were over-
encapsulated in order to blind the treatment
taken. I could not match this to any existing
terms, and would therefore like to request a
new term for this.




I have a legacy study where the action taken
= "Dose adjusted". This does not map to the
SDTM terminology, and the codelist is not
extensible.
Is this the same as Mitochondrial antibody? If
so, can this be added as a synonym? Applies
to LBTESTCD and LBTEST

Is this the same as N-terminal pro-Brain
Natriuretic Peptide?
Is this the same as Total Haemolytic
Complement (CH50)?
Is this the same as Type I collagen X-linked
C-telopeptide?

Is this the same as Heterophile Antibody
Mono screen?



Is this the same as Soluble VCAM1?




We also have Partial Pressure of Arterial
Oxygen - is this a new code or PO2 with
'Arterial' as location?
How do we differentiate from 1,25-Dihydroxy-
Vitamin D? We have 2 Vitamin D tests:
Calcidiol (inactive form) which is 25-Hydroxy-
Vitamin D; Calcitriol (active form) which
is1,25-Dihydroxy-Vitamin D
Can I question Gamma Globulin as a
synonym: As per Wiki: The most significant
gamma globulins are immunoglobulins
("Igs"), more commonly known as antibodies,
although some Igs are not gamma globulins,
and some gamma globulins are not Igs.

Can you please add Fibrinogen Degradation
Products as a Synonym as I believe this is
true based on research I've done.
http://peir.path.uab.edu/coag/article_77.shtml


I suggest the team modifies the definition of
PT to indicate that it is expressed in units of
time and that they develop a new testcd, test
name and definition (eg: PTACT or PTAT,
Prothrombin Time Activity, and a suitable
definition inidcating units expressed as a
percentage of activity.




On term C85659 L/g/min, remove the
synonym uL/ug/s from published CDISC
terminology. Add uL/ug/min as a CDISC SY.
Change c-code to C73755

Term mL/g/s is a synonym of term C85664
L/kg/s in the PKUNIT codelist. Please keep
L/kg/s as the CDISC PT. Synonyms are fine
for C85664 and do not need to be altered.

This identifies the NCI preferred name for a
term as identified in NCIt. **NOTE - This
column designates the human readable, fully
specified preferred term corresponding to the
NCI c-code, and is especially helpful for
searching NCIt to get the entire concept with
links to all instances of the term.

In the last version of controlled terminology
there is the codelist SCCD, but in my opinion
we need also de codelist SC in order to have
the meaning of the SCCD terms. i.e. in the
CODE column this new codelist SC, have to
have the same values than SCCD codelist
terms. Example: in the codelist SCCD there
is the value SALTYP (C74556) but there is
no way to link with the appropriate value of
this code. The solution I propose is the same
you have already implemented in VSTEST
and VSTESCD, LBTEST and LBTESTCD,
EGTEST and EGTESTCD, DATEST and
DATESTCD, TSPARM and TSPARMCD. If
you decide implement this codelist in a future
versionof controlled terminology, maybe you
have to take into account that "SC" is
included as a term for the codelist DOMAIN.



Emesis is "the act of vomiting", cannot be a
specimen type. This should be VOMIT.




I think the use of this unit is very common for
LAMZ PK parameter
Predominently used for WBC differentials,
reticulocytes and Hematocrit. For WBC diffs,
the data is converted to % by x100. For retics
and hct, the SI is 1 (as per Quest central
labs)
I have a couple of codes such as these
where the vendor defines the percentage
based on the reference test. I really need
confirmation whether these are valid units, or
whether the cod should just be % and leave
the LBTESTCD/LBTEST to define the
reference.
I have a number of units that begin with the
words casts and cells e.g. CELLS/HPF and
CASTS/UL. Can you tell me whether the
word should be upper or lowercase and
whether it should be singular or plural. i.e.
cell/HPF, CELL/HPF, cells/HPF or
CELLS/HPF or should the word be dropped
entirely and just have a unit of /HPF or /LPF?

The unit for High Power Field is HPF. Would
field be expressed as F or FIELD? F is the
unit for Fahrenheit so I wasnt sure.

Will Titer be spelt TITER or TITRE? Is it an
uppercase or lowercase code?
This has been used for a reticulocyte test
where this was the original unit and was
converted to '1' x 0.001
Is this the same as ELISA unit?




Ia this valid or should it be converted to a litre
equivalent?
Used for mean corpuscle volume and mean
platelet volume
Fmol values used for MCV, MCH etc



g% - Is this a synonym for g/dL? mg% - is
this a synonym for mg/dL?
Used for protein/creatinine ratio
If they are not synonyms can you please add
them as new terms.
BILI, WBC, and other terms can exist for
different types of samples: urin, haem, chem,
etc. Would it make sense to create one item
for each of these so that there is no
confusion? I know that at the SDTM level
there is a CATEGORY available, so that this
can be split out, but upon constructing
ADaMs in the BDS structure I run into issues
here...
Not Sure

Some studies may not have all the details of
how a dose was adjusted (up or down), just
that it was adjusted. Also older studies that
are completed but are being mapped to
SDTM, will not have a one to one match if
Dose Increased / Decreased was not
collected, and Dose Adjusted was.

If changed, please also update the definition




Please change the preferred term kg/m3 to
g/L as this is the standard unit for Labs.
Preferred term should be g/L.
Please change the CDISC preferred term of
g/m3 to mg/L as this is standard throughout
the industry. Change g/m3 to mg/L


Please change the CDISC preferred term
thous/uL to 10^3/uL as this is standard
throughout the industry. Change thous/uL to
10^3/uL.
Please consider changing the SEND CDISC
preferred term for mill/uL to 10^6/uL as this is
the industry standard. Add 10^6/uL to the
SDTM UNIT codelist.
Please change the CDISC preferred unit
ug/m3 to ng/L as this is the industry standard.
We would also like this change for
consistency with all the following preferred
CDISC terms; There are currently:
15 existing terms that end with '/L', including
kg/L, ug/L, mol/L, mmol/L, nmol/L, pmol/L,
and IU/L.
22 terms that end with '/mL' rather than cm3
5 terms that end with '/uL' rather than mm3
(interestingly, 'uL' alone doesn't even seem to
be in the list).
3 terms that end in '/dL'



Current codelist value WITHDRAWAL BY
SUBJECT. Suggest enhance to
WITHDRAWAL OF INFORMED CONSENT
BY SUBJECT to avoid possible confusion if
subject withdraws , for example, from one
phase of the study (treatment phase) but
allows data collection for follow-up phase.




"If the external reference for the controlled
terminology is not in upper case then the data
should conform to the case prescribed in the
external reference (e.g., MedDRA and
LOINC)." - MedDRA SOC terms are in
sentence case.
---




To be consistent with the use of plurals in
other types of cells.


This is one of numerous codes which are
represented in this way using the '10 to the
power of' format. Others include 10^2/uL,
10^3/mm3 up to 10^12/L. I'm looking for
guidance on how to represent these data. Is
10^3/uL best expressed as Thou/uL, or k/uL
or is 10^3/uL valid? This type of unit is
typically used in relation to cells e.g. WBC
differentials.
This is more of a question than a
suggestion. The CDISC definition of most
tests is "A measurement of ... in a biological
specimen," but some tests a described in
terms of a particular specimen such as
"urine." We have a study where sputum
cytology is being captured. An example of
one of the tests is squamous epithelial cell
count. The CDISC definition for EPISQCE
indicates is "A measurement of the
squamous epithelial cells present in a urine
specimen." Do we need to request a new
test code or is this test code appropriate for
use in other biological specimens? Thanks.


Change C78424 to C78745 in column B to
reflect correct codelist code subset.
This would also require the addition of a new
code (eg, AUCIFOD) to the PKPARMCD
codelist. This request was originated by a
pharmacokineticist in my organization who
saw that all other AUC parameters had
values normalized to Dose except this one.

C25298 C66741 Vital Signs Test Code
SYSBP Systolic Blood Should read 'Systolic
Blood Pressure'


In order to further the requirements of the
ODM/XML team for generating XML format
of CT, it is necessary to ensure that all
terminology spreadsheets look the same.
Therefore, I propose to make the following
changes to the ADaM CT spreadhsheet. 1)
Remove column F - this is a hold over from
previous iterations of the spreadsheet. 2)
Change the title of column E from CDISC
ADaM Submission Value to CDISC
Submission Value - to be inline with SDTM
spreadsheet.
In order to further the requirements of the
ODM/XML team for getting CT into XML
formation, it is necessary to ensure that all
terminology spreadsheets look the same.
Therefore, I propose to make the following
changes to the CDASH spreadsheet. 1)
Change the column title of column E from
CDISC CDASH Preferred Term to CDISC
Submission Value. 2) Change the column
title of column F from CDISC CDASH
Preferred Term to CDISC Synonym(s) - This
is in keeping with the SDTM terminology
spreadsheet format.

Please consider adding the above 10 terms
to CDISC's SDTM Controlled Terminology
Anatomical Locations Codelist in order to be
consistent with NCI Terminology. As a
precedent, the Anatomical Locations codelist
already contains the following terms:
Gastrointestinal System and Urinary System.
Thank you. APZ/06-Dec-2010




needed to locate stroke




The existing definition for both "Planned
number of subjects" and "PLANSUB" is "The
number of subjects entered in a clinical trial."
This is not correct. The field for "Planned
number"/PLANSUB is supposed to hold "The
number of subjects planned to be enrolled in
a clinical trial." This typically is based on
Sample Size calculations. The actual number
entered is a different concept.Change the
CDISC definition for these 2 entries to "The
number of subjects planned to be enrolled in
a clinical trial."


To make the codelist more complete and
negate the need for self addition of terms to
the extensible list
Please provide LBTEST and LBTESTCD
values for the above parameters or update
the associated information used in identifying
the controlled terminology as either these are
missing or are not easily identifiable




PLease provide a Frequency code for the
above medication frequecny to be used for
oral contraceptives or confirm in notes how
this should be mapped
Please add above to controlled terminology
list
                                                                                 Change    Implementation
             NCI Decision                         CDISC Decision
                                                                                  Type          Date

                                           This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.
                                           This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.

PCR is method in this suggested PT.        This request will be considered III            P5 2010
May want to make the term more specific    in the next lab terminology
for the Influenza A Virus DNA or RNA or    package P5.
something like that.
PCR is method in this suggested PT.        This request will be considered III            P5 2010
May want to make the term more specific    in the next lab terminology
for the Influenza A Virus DNA or RNA or    package P5.
something like that.
Alk Phos comes from Liver and Bone;        This request will be considered III            P5 2010
the bone Alk Phos is a different isoform   in the next lab terminology
to the bone Alk Phos. Lab test kits may    package P5.
be specific for either isoform.

Send to CDISC for Review                   This request will be considered III            P5 2010
                                           in the next terminology package
                                           FY2010.




Send to CDISC for Review                   This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.
Send to CDISC for Review                   This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.


Send to CDISC for Review                   This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.

Send to CDISC for Review                   This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.

Send to CDISC for Review                   This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.


Send to CDISC for Review                   This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.

Send to CDISC for Review                   This request will be considered III            P5 2010
                                           in the next lab terminology
                                           package P5.
Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.


Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.


Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.




Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.


Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.




Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.


Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.




Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.


Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.
Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.




Send to CDISC for Review   This request will be considered III   P5 2010
                           in the next lab terminology
                           package P5.


Send to CDISC for Review   This request will be considered II    P5 2010
                           in the next lab terminology
                           package P5.
Send to CDISC for review.             Will be included in P5 General   II    P5 2010
                                      Terminology




Relates to Request 20829. This was       Changes made on P4 March      I     Q1 2010
agreed to be changed to Subject Ethnic SDTM CT terminology
Group but was not done on the            publication
spreadsheet for some reason. This
change will be made with p4 publication.

Send to CDISC for review.             Will be included in P5 General   III   P5 2010
                                      Terminology




Send to CDISC for review.             Will be included in P5 Lab       III   P5 2010
                                      Terminology
Went in as part of P4. Let Debbie know it Changes made on P4 March           III   Q1 2010
is in SDTM with c-code C82621             SDTM CT terminology
                                          publication




Went in as part of P4. Let Debbie know it Changes made on P4 March           III   Q1 2010
is in SDTM with c-code C82621              SDTM CT terminology
                                           publication
Up until this point, CDISC has not been Will be included in Package 5        III   P5 2010
consistent about which form (-ate or -ic lab terminology
acid) that general is used as a PT. Either
is fine. Probably just check to see which
form labs use more often.

Agree. I have labeled this a type 1                                          I     Q1 2010
request because this needs to be fixed in
our database ASAP.




Agree                                       Agree                            II    Q3 2010




Agree                                       Agree                            II    Q3 2010




Send to CDISC for review                    This request will be considered II     P5 2010
                                            in the next lab terminology
                                            package P5.




Send to CDISC for review                    This request will be considered III    P5 2010
                                            in the next lab terminology
                                            package P5.


Send to CDISC for review                    This request will be considered III    P5 2010
                                            in the next lab terminology
                                            package P5.
Send to CDISC for review                 This request will be considered III       P5 2010
                                         in the next lab terminology
                                         package P5.




Send to CDISC for review                 This request will be considered III       P5 2010
                                         in the next lab terminology
                                         package P5.




Send to CDISC to discuss definition      Agree. Terminology group             II   Q3 2010
clarification of these two terms.        determines to remove the term
                                         Existing Treatment (EXISTRT)
                                         from the list and change the
                                         definition of CURTRT to 'The
                                         literal identifier of the therapy or
                                         medication that is currently
                                         being given per protocol.'

Send to CDISC for review                 This request will be considered III       P5 2010
                                         in the next lab terminology
                                         package P5.




Send to CDISC for review                 This request will be considered III       P5 2010
                                         in the next lab terminology
                                         package P5.




Send to CDISC for review                 This request will be considered III       P5 2010
                                         in the next lab terminology
                                         package P5.
Send to CDISC for review                 This request will be considered III       P5 2010
                                         in the next lab terminology
                                         package P5.
Send to CDISC for Review                 This request will be considered III       P5 2010
                                         in the next lab terminology
                                         package P5.


Send to CDISC for review. Include with   This request will be considered III       P5 2010
P5 lab stuff                             in the next lab terminology
                                         package P5.
Send to CDISC for review. Include with   This request will be considered III       P5 2010
P5 lab stuff                             in the next lab terminology
                                         package P5.
Send to CDISC for review. Include with    This request will be considered III    P5 2010
P5 lab stuff                              in the next lab terminology
                                          package P5.

Send to CDISC for review. Include with    This request will be considered III    P5 2010
P5 lab stuff                              in the next lab terminology
                                          package P5.
Agree; Also will need to change       Agree                                III   Q3 2010
existing CDISC definitions and the c-
codes. New Definition type: A
measurement of the HXV viral load in
a biological specimen.
Agree                                 Agree                                II    Q3 2010


Send to CDISC for review.                 Updated text to read          II       Q3 2010
                                          C49610 C66734
                                          Domain Abbreviation
                                          SC     Subject
                                          Characteristics "The subject
                                          characteristics domain is for
                                          data not collected in other
                                          domains that is subject-
                                          related.




Send to CDISC for review; CDISC           Swab would be the collection III       No Change
has published 'Nasopharynx' C12423        method, (in suppqual).
as part of the Anatomical Location        'Nasopharynx' C12423 is the
codelist. Should it be in two places or   location and the specimen is
is this an implementation issue?          possibly "mucus". No
                                          change
Send to CDISC for review                  Will remove "surface" from II          Q3 2010
                                          Hepatitis A & C



Send to CDISC for review                  Agree to add                     III   Q3 2010
Send to CDISC for review             Based on expert terminology III     No Change
                                     resources we willnot add. If
                                     FDA were to refer to one
                                     product as an "OVER
                                     ENCAPSULATED TABLET"
                                     and to another similar
                                     appearing product as a
                                     "CAPSULE", then those two
                                     products could never be
                                     assessed for bioequivalence
                                     because federal regulations
                                     require pharmaceutical
                                     equivalence. the United
                                     States Pharmacopeia does
                                     not have the dosage form
                                     term "OVER
                                     ENCAPSULATED TABLET"


Send to CDISC for review                                           III   TBD




Yes, these are synonymous.           Agree to add synonym          III   Q3 2010




Yes, these are synonymous.           Agree to add synonym. P6      III   TBD


Total hemolytic complement (CH50) Agree to add 2 synonyms          III   Q3 2010
is the best functional assay of the     CH50 and Total Hemolytic
complete complement sequence.           Complement
CH50 is often decreased in SLE,
glomerulonephritis and other immune
complex diseases. A normal CH50
level indicates that all the
components, C1 through C9, are
present. However, individual
complement factors may be depleted
50 to 80% without affecting CH50
activity. Depletion of alternative
factors is not detected. For this
reason, it may be necessary to
measure individual complement
components.
(http://www.clinlabnavigator.com/Test
s/ComplementProfile.html). Based on
this information, since the CH50 test
is a reflection of total complement (as
is our existing term), I think that
these terms are synonymous.
I think the X-linked is actually      Agree to add synonym          III    Q3 2010
referring to a cross-linking of the
Type I Collagen C-telopeptides.
Yes. This test is screening for the   Will not add new test. Should III    No Change
presence of Heterophile Antibodies, be mapped to HTPHAB
which is indicative of Mononucleosis.
GSK should map to the CDISC PT.

There are two different forms of                                     III   Q3 2010
VCAM1. Membrane-bound and
soluble. More info: 'Serum levels of
soluble vascular cell adhesion
molecule 1 (sVCAM-1) shed from its
membrane-bound form are elevated
in hypertension.
(http://content.karger.com/ProdukteD
B/produkte.asp?Doi=112941).'
Send to CDISC for review             Yes, location Atrial            III   No Change



These are different compounds and     Will need to add a term,       III   Q3 2010
so would probably require different   synonym and clarify
lab tests.                            definition


She is correct. This must have been   Remove synonym; Gamma          II    Q3 2010
an oversight on our part because      Globulin
Immunoglobulin G and Gamma
Globulin are coded separately in
NCIt.


These are not synonymous.             Agree with NCI comment,        II    No Change
Thrombin converts soluble fibrinogen will not add
into insoluble fibrin. They are coded
separately in Thesaurus since they
are two separate proteins.

Send to CDISC for review              Will consider with P6          III   TBD




Agree                                 Agree                          II    Q4 2010
Agree                              Agree                        II    Q4 2010


Agree                              Agree                        III   Q4 2010




Agree                              Agree                        II    Q4 2010




Send to CDISC for review           Add ot package 6. Until we   III   TBD
                                   add terms for SCTEST
                                   please use the synonym.




Send to CDISC for review; Emesis is Agree with NCI - No Change II     No Change
considered both a SY of 'Vomit' and
'Vomitus' from multiple sources, the
greek origin use of the word is as a
noun, it is used in clinical practice as
a noun, and it is currently published
and in use by the CDISC community
and is not technically incorrect to use
the word as a specimen. NCI feels
that CDISC does not need to change
the PT of this terms unless
necessary.


Send to CDISC for review           Discuss with P 6 terms.      III   TBD
Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD


Send to CDISC for review   Discuss with P 6 terms.   III   TBD



Send to CDISC for review   Discuss with P 6 terms.   III   TBD


Send to CDISC for review   Discuss with P 6 terms.   III   TBD


Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD


Send to CDISC for review   Discuss with P 6 terms.   III   TBD


Send to CDISC for review   Discuss with P 6 terms.   III   TBD



Send to CDISC for review   Discuss with P 6 terms.   III   TBD


Send to CDISC for review   Discuss with P 6 terms.   III   TBD
Send to CDISC for review   Discuss with P 6 terms.   III   TBD



Send to CDISC for review   Discuss with P 6 terms.   III   TBD


Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD




Send to CDISC for review   Discuss with P 6 terms.   III   TBD


Send to CDISC for review   Discuss with P 6 terms.   III   TBD
Send to CDISC for review               CDISC has made the             III   No Change
                                       decision that the specimen
                                       will not be incorported into
                                       the varialbe name. The
                                       specimen goes into the
                                       LBSPEC field



Send to CDISC for review; Follow up Sent email to requestor to        III   TBD
required.                           ask for more information
Send to CDISC for review               Further discussion needed      III   TBD




This is being taken care of in the     Agree                          III   TBD
terminology release for Q3 and P5.
This request can be closed.




Send to CDISC for review.              Still in discussion            II    TBD



Send to CDISC for review.              Still in discussion            II    TBD




Send to CDISC for review. - This will Still in discussion             II    TBD
be resolved once we check with FDA


Send to CDISC for review. - This will Still in discussion             III   TBD
be resolved once we check with FDA
Send to CDISC for review.             Still in discussion          II    TBD




Send to CDISC for review.                                          II    TBD




Send to CDISC for review                                           II    TBD




Agree. Change PT in TSPARM                                         III   TBD
codelist from Age Group to Age Span
and add Age Group as a synonym.


Send to CDISC for review              Agree to change to Platelets II    Q2 2011



Send to CDISC for review              Still in discussion          III   TBD
Send to CDISC for review. We may Discuss with P7           III   TBD
need to review all defs to make them
less specimen specific.




Send to CDISC for review            Agree                  I     Q1 2011


Send to CDISC for review            Add to Package 6       III   Q2 2011




To clarify, the term in the synonym CDISC agrees to this   II    Q2 2011
column needs to be changed. Agree. change.



Send to CDISC for review            Agree                  I     Q1 2011
Send to CDISC for review           Agree                         I     Q1 2011




Send to CDISC for Review           Will consider for Package 7   III   TBD




Send to CDISC for Review           Will consider for Package 7, III    TBD
                                   Brain Stem is in Package 6



Agree; send to CDISC for review.   Will consider for Package 7   II    TBD




Send to CDISC for Review           Will consider for Package 7   III   TBD
Send to CDISC for Review   Will consider for Package 7   III   TBD




Send to CDISC for Review   Will consider for Package 7   III   TBD




Send to CDISC for Review   Will consider for Package 7   III   TBD
                            Request
               Date of      Code                         Submitter                        Submitter
 Status                               Submitter Name                   Submitter E-mail
             Submission                                  Affiliation                       Phone

Open      1/7/2011 14:44    30408     Erin Muhlbradt   LMCO            erin.e.muhlbradt
                                                                       @lmco.com




Open      1/7/2011 15:41    30409     john                             john.swithenbank
                                      Swithenbank                      @covance.com


Open      1/14/2011 17:15   30447     john                             john.swithenbank
                                      Swithenbank                      @covance.com




Open      1/21/2011 18:31   30482     Audrey Walker    Charles River Audrey.Walker@c 514-630-
                                                                     rl.com          8200 ext
                                                                                     8717

Open      1/21/2011 18:32   30483     Audrey Walker    Charles River Audrey.Walker@c 514-630-
                                                       Laboratories rl.com           8200 ext
                                                                                     8718

Open      1/21/2011 18:33   30484     Audrey Walker    Charles River Audrey.Walker@c 514-630-
                                                       Laboratories rl.com           8200 ext
                                                                                     8718

Open      2/4/2011 14:11    30557     Richard Shaw     Parexel         richard.shaw@par
                                                                       exel.com




Open      2/4/2011 14:12    30558     Erin Muhlbradt   LMCO            erin.e.muhlbradt
                                                                       @lmco.com
Open   2/4/2011 14:14    30559   Brian V.         ERT           bharrington@ert.c
                                 Harrington       (eResearch    om
                                                  Technology)




Open   1/7/2011 14:44    30408   Erin Muhlbradt   LMCO          erin.e.muhlbradt    703 891
                                                                @lmco.com           6415



Open   1/7/2011 15:41    30409   john                           john.swithenbank
                                 Swithenbank                    @covance.com




Open   1/14/2011 17:15   30447   john                           john.swithenbank
                                 Swithenbank                    @covance.com




Open   1/21/2011 18:31   30482   Audrey Walker    Charles River Audrey.Walker@c 514-630-
                                                  Laboratories rl.com           8200 #xt
                                                                                8717

Open   1/21/2011 18:32   30483   Audrey Walker    Charles River Audrey.Walker@c 514-630-
                                                  Laboratories rl.com           8200 #xt
                                                                                8718
Open   1/21/2011 18:33   30484   Audrey Walker    Charles River Audrey.Walker@c 514-630-
                                                  Laboratories rl.com            8200 #xt
                                                                                 8719
Open   2/4/2011 14:11    30557   Richard Shaw     PAREXEL       richard.shaw@par
                                                  International exel.com




Open   2/4/2011 14:12    30558   Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891-
                                                                @lmco.com          6415



Open   2/4/2011 14:14    30559   Brian V.         ERT           bharrington@ert.c 215-282-
                                 Harrington       (eResearch    om                5565
                                                  Technology)




Open   3/4/2011 13:10    30740   John                           john.swithenbank
                                 Swithenbank                    @covance.com
Open   3/4/2011 13:11   30741   Erin Muhlbradt   LMCO        erin.e.muhlbradt   703 89106415
                                                             @lmco.com




Open   3/4/2011 13:12   30742   Anna Pron-Zwick AstraZeneca anna.pron-       (302) 885-
                                                Pharmaceutic zwick@astrazene 5109
                                                als          ca.com




Open   3/4/2011 13:13   30743   John                         john.swithenbank
                                Swithenbank                  @covance.com




Open   3/4/2011 13:14   30744   Anna Pron-Zwick AstraZeneca anna.pron-       (302) 885-
                                                Pharmaceutic zwick@astrazene 5109
                                                als          ca.com



Open   3/4/2011 13:15   30745   Claire West      GSK         claire.m.west@gs
                                                             k.com
Open   3/4/2011 13:16      30746    Claire West      GSK           claire.m.west@gs
                                                                   k.com




Open      3/4/2011 13:20      30747 Monica Mattson   Celgene       mmattson@celge 913-266-
                                                     Corporation   ne.com         0511

Open      3/9/2011 12:47      30759 Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891-
                                                                   @lmco.com          6415



Open     3/31/2011 17:02      30860 Nik Pemble       J&J           npemble@its.jnj.c +32 475
                                                                   om                559 417




Open     3/31/2011 17:04      30861 Chris Tolk       CDISC         ctolk@cdisc.org    203 220
                                                                                      9345

Open     3/31/2011 17:04      30862 Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891-
                                                                   @lmco.com          6415
Open     3/31/2011 17:07      30863 Dennis Noe       MPI          Dennis.Noe@mpi.
                                                                  com



Open     3/31/2011 17:08      30864 Guy Genereux     Sunovion     guy.genereux@su 508-357-
                                                     Pharmaceutic novion.com      7517
                                                     als Inc.



Open     3/31/2011 17:11      30866 Guy Genereux     Sunovion     guy.genereux@su 508-357-
                                                     Pharmaceutic novion.com      7517
                                                     als Inc.



Open     3/31/2011 17:12      30867 Guy Genereux     Sunovion     guy.genereux@su 508-357-
                                                     Pharmaceutic novion.com      7517
                                                     als Inc.




Open     3/31/2011 17:13      30868 David Borbas     Jazz         David.Borbas@ja 650 496
                                                     Pharmaceutic zzpharma.com    2637
                                                     als



Open     3/31/2011 17:16      30869 Chris Tolk       CDISC        ctolk@cdisc.org    203 220
                                                                                     9345

Open   4/1/2011 15:18      30895    David Borbas     Jazz         David.Borbas@ja 650 496
                                                     Pharmaceutic zzpharma.com    2637
                                                     als



Open   4/1/2011 15:20      30896    Erin Muhlbradt   LMCO         erin.e.muhlbradt   703 891
                                                                  @lmco.com          6415

Open   4/1/2011 15:21      30897    Erin Muhlbradt   LMCO         erin.e.muhlbradt   703 891
                                                                  @lmco.com          6415




Open   4/1/2011 15:21      30898    Erin Muhlbradt   LMCO         erin.e.muhlbradt   703 891
                                                                  @lmco.com          6415
Open   4/1/2011 15:23    30899   Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891
                                                                @lmco.com          6415

Open   4/6/2011 14:08    30936   Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891
                                                                @lmco.com          6415

Open   4/6/2011 14:09    30937   Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891
                                                                @lmco.com          6415

Open   4/6/2011 14:10    30938   Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891
                                                                @lmco.com          6415

Open   4/6/2011 14:12    30939   John                           john.swithenbank
                                 Swithenbank                    @covance.com




Open   4/6/2011 14:13    30940   John                           john.swithenbank
                                 Swithenbank                    @covance.com
Open   4/18/2011 13:53   31000   Fugui Dong      Pharmanet     fdong@pharmane 609-275-
                                                                t.com            9080




Open   4/18/2011 13:54   31001   Fugui Dong       Pharmanet     fdong@pharmane 609-275-
                                                                t.com          9080



Open   4/18/2011 13:56   31002   Fugui Dong       Pharmanet     fdong@pharmane     609-275-
                                                                t.com              9080
Open   4/18/2011 13:57   31003   Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891
                                                                @lmco.com          6415
Open   4/22/2011 17:00   31050   Tore Haglund     AstraZeneca   tore.haglund@ast   +46 8 553
                                                                razeneca.com       26048
Open   4/29/2011 17:53   31102   Debbie O'Neill   Merck         debra_oneill@me    267-305-
                                                                rck.com            8124


Open   4/29/2011 17:54   31103   Debbie O'Neill   Merck         debra_oneill@me 267-305-
                                                                rck.com         8125


Open   4/29/2011 17:55   31104   Debbie O'Neill   Merck         debra_oneill@me 267-305-
                                                                rck.com         8126
Open   4/29/2011 17:56   31105   Debbie O'Neill   Merck        debra_oneill@me 267-305-
                                                               rck.com         8127


Open   5/20/2011 13:47   31281   Allen Glover     Covance      allen.glover@cov 317-797-
                                                               ance.com         9425




Open   5/20/2011 13:48   31282   Debbie O'Neill   Merck        debra_oneill@me 267-305-
                                                               rck.com         8124




Open   5/20/2011 13:49   31283   Nicholas Pemble Johnson and   npemble@its.jnj.c
                                                 Johnson       om




Open   5/20/2011 13:51   31284   Richard Shaw     PAREXEL      richard.shaw@par 0114 225
                                                  INTERNATIO   exel.com         1225
                                                  NAL
Open   5/20/2011 13:52   31285   Richard Shaw     PAREXEL      richard.shaw@par 0114 225
                                                  INTERNATIO   exel.com         1225
                                                  NAL




Open   5/20/2011 13:53   31286   Richard Shaw     PAREXEL    richard.shaw@par 0114 225
                                                  INTERNATIO exel.com         1225
                                                  NAL
Open   5/20/2011 13:54   31287   Steve Kopko      CDISC         skopko@cdisc.or 484-868-
                                                                g               0251




Open   5/20/2011 13:56   31288   Erin Muhlbradt   LMCO          erin.e.muhlbradt   703 891
                                                                @lmco.com          6415

Open   5/20/2011 13:56   31289   Steve Kopko      CDISC         skopko@cdisc.or 484-868-
                                                                g               0251




Open   5/20/2011 14:01   31290   erin.e.muhlbradt LMCO          erin.e.muhlbradt   703 891
                                 @lmco.com                      @lmco.com          6415




Open   5/20/2011 14:02   31291   Steve Kopko      CDISC         skopko@cdisc.or 484-868-
                                                                g               0251




Open   5/20/2011 14:04   31292   Laura Allen      Merck &amp;   laura_allen@merc 267-305-
                                                  Co.           k.com            8906

Open   5/20/2011 14:06   31293   Debbie O'Neill   Merck         debra_oneill@me    267-305-
                                                                rck.com            8124
Open   5/20/2011 14:07   31294   Debbie O'Neill   Merck         debra_oneill@me    267-305-
                                                                rck.com            8124
Open   5/20/2011 14:08   31295   David Borbas   Jazz         David.Borbas@ja 650 496
                                                Pharmaceutic zzpharma.com    2637
                                                als




Open   5/20/2011 14:08   31296   john                           john.swithenbank
                                 Swithenbank                    @covance.com


Open   5/20/2011 14:09   31297   john                           john.swithenbank
                                 Swithenbank                    @covance.com
Open   5/27/2011 12:17   31312   Michael Ward   Eli Lilly and   mjward@lilly.com 317-433-
                                                Company                          4172




Open   5/27/2011 12:18   31313   Michael Ward   Eli Lilly and   mjward@lilly.com 317-433-
                                                Company                          4172




Open   5/27/2011 12:19   31314   Michael Ward   Eli Lilly and   mjward@lilly.com 317-433-
                                                Company                          4172




Open   5/27/2011 12:20   31315   Bess LeRoy                     bleroy@c-
                                                                path.org
Open   5/27/2011 12:22   31316   Bess LeRoy                     bleroy@c-
                                                                path.org
                              New Term or Codelist/Existing Term
Request Type CDISC Codelist
                                      or Code Number

Modify        SDTM-FREQ       Add synonym to C25473 QD to be
Existing Term                 compliant with CDASH v1.1




Create New   SDTM-LBTEST      Please add a code for Tuberculosis.
Term                          Suggested option LBTEST =
                              Tuberculosis ; LBTESTCD = TB

Modify        SDTM-LBTEST     typographical error
Existing Term




Create New   SDTM-LBTEST      Amorphous phosphate
Term


Create New   SDTM-LBTEST      Amorphous Urate
Term


Create New   SDTM-LBTEST      BLOOD (in Urine)
Term


Create New   SDTM-LBTEST      ADENOPL - Adeno Plasma qPCR;
Term                          ADENOUR - Adeno Urine qPCR;
                              BKVPL - BKV Plasam qPCR;
                              BKVUR - BKV Urine qPCR; CMVPL -
                              CMV Plasma qPCR; EBVPLÂ - EBC
                              Plama qPCR

Modify        SDTM-LBTEST     C74723 - Turbidity
Existing Term
Create New   SDTM-          Codelist name = ECG Result;
Term         EGSTRESC       Additions to existing codelist




Modify        SDTM-FREQ     Add synonym to C25473 QD to be
Existing Term               compliant with CDASH v1.1



Create New   SDTM-LBTEST    Please add a code for Tuberculosis.
Term                        Suggested option LBTEST =
                            Tuberculosis ; LBTESTCD = TB



Modify        SDTM-LBTEST   typographical error
Existing Term




Create New   SDTM-LBTEST    Amorphous phosphate
Term


Create New   SDTM-LBTEST    Amorphous Urate
Term
Create New   SDTM-LBTEST    BLOOD (in Urine)
Term

Create New   SDTM-LBTEST    ADENOPL - Adeno Plasma qPCR;
Term                        ADENOUR - Adeno Urine qPCR;
                            BKVPL - BKV Plasam qPCR;
                            BKVUR - BKV Urine qPCR; CMVPL -
                            CMV Plasma qPCR; EBVPL - EBC
                            Plama qPCR

Modify        SDTM-LBTEST   C74723 - Turbidity
Existing Term



Create New   SDTM-          Codelist name = ECG Result;
Term         EGSTRESC       Additions to existing codelist




Modify        SDTM-         Minor edit if possible to change the
Existing Term VSTESTCD      associated CDISC SYNONYM text to
                            Systolic Blood Pressure to match the
                            CDISC SYNONYM text for VSTEST
                            and to also bring consistency with
                            the presentation as per Diastolic BP
Modify        SDTM-LBTEST   Change the c-code of
Existing Term               Glucose.C41376 will need to be re-
                            coded.




Create New   SDTM-          Please consider adding the following
Term         LBTESTCD       to the SDTM LBTEST and
                            LBTESTCD Codelists: Iohexol
                            Glomerular Filtration Rate; Cystatin
                            C Glomerular Filtration Rate; 51Cr-
                            EDTA Glomerular Filtration Rate




Create New   SDTM-LBTEST    Please provide a LBTEST and
Term                        LBTESTCD for Anti-Factor Xa
                            activity as this parameter is missing
                            from the pick list yet units for its
                            reporting are present in the UNIT
                            terminology. Please consider
                            LBTEST =Anti-Factor Xa activity
                            LBTESTCD = ANTIFXA
Modify        SDTM-         Tyrosine Crystals / CYTYRO /
Existing Term LBTESTCD      C74683 / Update to definition
                            required



             SDTM-UNIT      Inconsistency between PKUNIT and
                            UNIT codelist in relation to
                            submission values vs synonyms




Other
Create New   SDTM-UNIT      Use of words to express 10^2, 10^3,
Term                        10^5, 10^6 etc.




Create New   SDTM-LOC       1) BONE MARROW; and (2) SOFT
Term                        TISSUE

Other        Other          CDASH terminology spreadsheet -
                            SUNCF codelist code for C25471
                            and C25627. Copy-paste error.
                            Change codelist code to C83004 in
                            column B of spreadsheet.
Modify        SDTM-LBTEST   AMYLASE - I am having an issue
Existing Term               with Amylase. In my trial, we are
                            collecting both pancreatic amylase
                            and total amylase. Currently,
                            Amylase in the terminology is
                            representing pancreatic amylase
                            (per defn). For consistency, the
                            current code should be updated to
                            AMYLASEP and then AMYLASE
                            should be used to represent total
                            amylase.

Modify        SDTM-TSPARM   C49692 - Modify definition to The
Existing Term               planned number of subjects entered
                            in a clinical trial
Create New   SDTM-EGEST     Add term ECG Abnormality to the
Term                        EGTEST/CD codelist. Suggest ECG
                            Abnormality for EGTEST and
                            EGABNORM for EGTESTCD.
Create New SDTM-PKPARM      Modify existing terms and add new
Terms &                     terms to PKPARM/CD codelist.
Modify
Existing
Terms
Modify        SDTM-LBTEST   Mycobacterium tuberculosis IFN
Existing Term               Gamma Response; Soluble Vascular
                            Cell Adhesion Molecule 1; These --
                            TEST values are longer than 40
                            chars, which violates SDTM
                            principles.
Modify        SDTM-         AGESPAN submission value
Existing Term TSPARMCD      (code=C20587) should be
                            AGEGROUP to match related
                            TSPARM value of "Age Group".
                            CDISC Synonym should be "Age
                            Group".
Modify        SDTM-LBTEST   Vitamin B9 submission value
Existing Term               (code=C74676) should have the
                            words in the CDISC Synonym value
                            reversed in order. Should read
                            "Vitamin B9; Folic Acid" to be
                            consistent with CDISC Synonym
                            values for other vitamins.



Create New   SDTM-VSTEST    Oxygen Saturation Percentage --
Term                        VSTESTCD O2SAT




Modify        SDTM-TSPARM   C49697 - Change definition for
Existing Term               LENGTH to Planned length of
                            observation for a single subject.
Create New   SDTM-          Add HOLTER MONITOR to this
Term         EGMETHOD       codelist




Modify        SDTM-FREQ     C64496 BID
Existing Term

Modify        SDTM-PKUNIT   C71205 ug/day; C71211 ug/min;
Existing Term               C67406 umol/day; C48152 ug




Modify        SDTM-AGEU     C25529 HOURS
Existing Term
Modify        SDTM-UNIT    C25529 HOURS
Existing Term

Modify        CDASH-       C64496; C64527; C64530; C64525;
Existing Term EXDOSFRQ     C64498; C64499; C17998 - Codelist
                           Name
Modify        CDASH-       C25473 - Codelist Name
Existing Term EXDOSFRQ

Modify        CDASH-       C78745 - Codelist Name SY
Existing Term EXDOSFRQ

Create New   SDTM-LBTEST   Please review and add where
Term                       applicable codes for the following
                           Lab parameters values where
                           possible (suggestions made below):
                           LBTEST=Herpes Simplex Virus 1
                           IgG LBTESTCD=HSV1IgG;
                           LBTEST=Herpes Simplex Virus 1
                           IgM LBTESTCD=HSV1IgM;
                           LBTEST=Herpes Simplex Vir

Create New   SDTM-FREQ     Please provide a frequency code for
Term                       5 times daily
Create New   SDTM-         TSAT
Term         LBTESTCD




Create New   SDTM-         CHR
Term         LBTESTCD



Create New   SDTM-         CA_PHOS
Term         LBTESTCD
Other        SDTM-LOC      Change concept code C33737
                           (TARSUS BONE) to C12796
Create New   SDTM-FREQ     QN = Nightly (Occurring or done
Term                       each night).
Create New   SDTM-FREQ     1XWK
Term


Create New   SDTM-FREQ     5XWK
Term


Create New   SDTM-FREQ     6XWK
Term
Create New   SDTM-FREQ     7XWK
Term


Create New   None          SEND-SPEC - JOINT, STIFLE is a
Term                       complex joint in the hind limbs of
                           quadruped mammals such as the
                           sheep, horse or dog. It is the
                           equivalent joint to the human knee. It
                           is often the largest synovial joint in
                           the body.
Create New   SDTM-LOC      Please add the following terms to the
Term                       Anatomical Location codelist. Our
                           preference is for addition as
                           submission value terms but if not,
                           can they be added as synonyms.
                           The terms are: BOTH EYES; LEFT
                           EYE; RIGHT EYE; LEFT ARM;
                           RIGHT ARM; BUTTOCK; LEFT
                           BUTTO
Create New   SDTM-         AMBIENT
Term         SPECCOND




Create New   SDTM-UNIT     Additional term for unit codelist:
Term                       FRACTION; cm H20; mL/cm H20

Create New   SDTM-         New terms for VSTESTCD VSTEST
Term         VSTESTCD      codelists: FIO2 - Fraction of Inspired
                           Oxygen; PA02/FIO2 - Partial
                           Pressure of Arterial Oxygen/Fraction
                           of Inspired Oxygen; SA02 - Arterial
                           Oxygen Saturation; SPO2 -
                           Peripheral Oxygen Saturation;
                           SPO2/FIO2 - Peripheral Oxygen

Create New   SDTM-LBTEST   Additional LBTESTCD LBTEST
Term                       terms; HASA - Human Anti-Sheep
                           Antibody Bridging (Total); HASAIGG -
                           Human Anti-Sheep Antibody IgG;
                           PROTC - Protein C; TNFA - Tumour
                           Necrosis Factor alfa; TNFAFC -
                           Tumour Necrosis Factor alfa (FC)
Create New   SDTM-          VSTESTCD VSTEST Definition -
Term         VSTESTCD       TRSKNFÂ Â Triceps skinfold
                            thickness        NINDS
                            Definition: Triceps skinfold thickness -
                            centimeters; SSSKNFÂ Â
                            Subscapular skinfold thicknessÂ
                            NINDS Definition: Subscapular
                            skinfold thickness - centimeters;
                            HDCIRCÂ Â Head C




Modify        SDTM-LBTEST   C81982
Existing Term

Create New   SDTM-FREQ      Additional Dose Frequency value =
Term                        XX times per month; Defined as the
                            &quot;number of times per
                            month&quot; the medication was
                            taken. The investigator enters the
                            number on the CRF



Modify        SDTM-TSPARM   C50400
Existing Term




Other        SDTM-FREQ      Request the additional FREQUENCY
                            values based on the NINDS
                            definition = Average or typical
                            frequency during the year of greatest
                            use. List number of uses per day
                            (_/d), week (_/w), month (_/m), or
                            year (_/y), as applicable. XX times
                            per day; XX times per


Create New   SDTM-LBTEST    LBTEST:Â Interleukin 2 Receptor;
Term                        LBTESTCD: INTLK2R

Create New   SDTM-FRM       Add term 'CAPLET' to FRM Codelist
Term
Create New   SDTM-UNIT      Add unit 'L/h' to Unit codelist
Term
Modify        SDTM-SOC      Change the SOC to MedDRA
Existing Term               sentence case. Example -
                            &quot;CARDIAC DISORDERS&quot;
                            should be &quot;Cardiac
                            disorders&quot;




Create New   SDTM-VSRESU    Please add meter to the Vital signs
Term                        controlled terminology as we are
                            recieving some heights captured as
                            meters
Create New SDTM-LBTEST      Please supply a new lab test for lab
Term                        parameter Platelet Crit
Modify        SDTM-STENRF   Please change 'U' to 'UNKNOWN'
Existing Term               (C17998).




Modify        SDTM-SEX      Please change 'U' to 'UNKNOWN'
Existing Term               (C17998) in SDTM-SEX




Modify        SDTM-NY       Please change 'U' to 'UNKNOWN'
Existing Term               (C17998) in SDTM-NY




Create New   SDTM-FREQ      PER YEAR
Term
Create New   SDTM-UNIT      PACK
Term
                                                    Change   Implement
             Detailed Description
                                                     Type    ation Date

Add synonym of 'Once Daily' to concept QD in II              TBD
SDTM-FREQ codelist. QD/Quaque Die literally
means Once a day or Once daily. This change
will then ensure that terminology is aligned with
CDASH 1.1.

Option missing from codelist                    III          TBD



There seems to be a typographical error in the I             TBD
codelist for the following Laboratory test and
associated synonym and NCI term. Should
Luekocyte Cell Clumps not be Leukocyte Cell
Clumps for this test and the associated
information in LBTEST and LBTESTCD.


in the Lab Package 6 Amorphous Cyrstal         III           TBD
contains both phospate and urate we measure
them both separately, therefore they both need
terms
in the Lab Package 6 Amorphous Cyrstal         III           TBD
contains both phospate and urate we measure
them both separately, therefore they both need
terms
There does not seem to be a CDISC              III           TBD
measurement for Blood (in the urine).


Virology assays encountered in clinical study   III          TBD
data mapped to SDTM LB domain




Remove the synonym 'Clarity' from the concept II             TBD
'Turbidity'. Clarity has been determined to be
non-synonymous and will be put in as a
separate term with P6 terminology.
Thank you for the opportunity to review the        III   TBD
controlled terminology Package 6. We
reviewed the terminology and noticed there are
some potential ECG finding that are missing in
the ECG Result SDTM Terminology. I listed all
of these potential findings below. We would like
to see if it is possible to include these findings
within the SDTM to ensure our customers
remain CDISC compliant. We welcome any
questions you may have on the list of potential
findings below: Normal Sinus Rhythm; Other
Rhythm; Unable to Assess; Atrial Bigeminy;
Frequent Atrial Premature Complexes (>2);
Frequent Atrial Premature Complexes (>3);
Frequent Ventricular Premature Complexes
(>2); Other Conduction; Prolonged QTc; Other
ST Segment; Digitalis Effect; Other T Waves;
Abnormal U Waves; Absent [U Wave]; Other U
Waves; Indeterminate; Other Axis; Antero
Lateral MI V3-V6; Antero Septal MI V1-V4;
Extensive Anterior MI 1, L, V1-V6; High Lateral
MI 1, AVL; Myocardial Ischemia; New Anterior
MI V3, V4; New Antero Lateral MI V3-V6; New
Antero Septal MI V1-V4; New Extensive
Anterior MI 1, L, V1-V6; New High Lateral MI 1,
AVL; New Inferior MI (2), 3, F; New Lateral MI
1, L, V5, V6; New Septal MI V1, V2, (V3); New
or Acute MI; Old Anterior MI V3, V4; Old Antero
Add synonym of 'Once Daily' to concept QD in II          TBD
SDTM-FREQ codelist. QD/Quaque Die literally
means Once a day or Once daily. This change
will then ensure that terminology is aligned with
CDASH 1.1.
Option missing from codelist                       III   TBD




There seems to be a typographical error in the I         TBD
codelist for the following Laboratory test and
associated synonym and NCI term. Should
Luekocyte Cell Clumps not be Leukocyte Cell
Clumps for this test and the associated
information in LBTEST and LBTESTCD.

in the Lab Package 6 Amorphous Cyrstal         III       TBD
contains both phospate and urate we measure
them both separately, therefore they both need
terms
in the Lab Package 6 Amorphous Cyrstal         III       TBD
contains both phospate and urate we measure
them both separately, therefore they both need
terms
There does not seem to be a CDISC                  III   TBD
measurement for Blood (in the urine).

Virology assays encountered in clinical study      III   TBD
data mapped to SDTM LB domain




Remove the synonym 'Clarity' from the concept II         TBD
'Turbidity'. Clarity has been determined to be
non-synonymous and will be put in as a
separate term with P6 terminology.

Thank you for the opportunity to review the        III   TBD
controlled terminology Package 6. We
reviewed the terminology and noticed there are
some potential ECG finding that are missing in
the ECG Result SDTM Terminology. I listed all
of these potential findings below. We would like
to see if it is possible to include these findings
within the SDTM to ensure our customers
remain CDISC compliant. We welcome any
questions you may have on the list of potential
findings below: Normal Sinus Rhythm; Other
Rhythm; Unable to Assess; Atrial Bigeminy;
Frequent Atrial Premature Complexes (>2);
Frequent Atrial Premature Complexes (>3);
Frequent Ventricular Premature Complexes
(>2); Other Conduction; Prolonged QTc; Other
ST Segment; Digitalis Effect; Other T Waves;
Abnormal U Waves; Absent [U Wave]; Other U
Waves; Indeterminate; Other Axis; Antero
Lateral MI V3-V6; Antero Septal MI V1-V4;
Extensive Anterior MI 1, L, V1-V6; High Lateral
MI 1, AVL; Myocardial Ischemia; New Anterior
MI V3, V4; New Antero Lateral MI V3-V6; New
Antero Septal MI V1-V4; New Extensive
Anterior MI 1, L, V1-V6; New High Lateral MI 1,
AVL; New Inferior MI (2), 3, F; New Lateral MI
1, L, V5, V6; New Septal MI V1, V2, (V3); New
or Acute MI; Old Anterior MI V3, V4; Old Antero
Minor edit if possible to change the associated II       TBD
CDISC SYNONYM text to Systolic Blood
Pressure to match the CDISC SYNONYM text
for VSTEST and to also bring consistency with
the presentation as per Diastolic BP
Glucose was one of the first labtests that was III       TBD
added to CDISC CT. At that time, it was coded
to the concept C41376 Plasma Glucose
Measurement in NCIT. I am not convinced that
the specimen in which it is being measured
should be included within the concept itself and
this tends to go against the CDISC data model.
I suggest to assign the concept Glucose
Measurement to a new c-code as we wouldn't
want someone using C41376 if they are
measuring glucose in another specimen such
as urine, whole blood, etc.

The three above requests can be measured in III          TBD
both Plasma and Serum. Usual unit of
measurement reported for all three types of
GFR measurements is mL/min/1.73 m2. These
are more specific as to the substance being
cleared when measuring GFR. Included are
some links for additional information:
http://www.diazyme.com/products/reagents/DZ
133C-3.php;
http://jasn.asnjournals.org/content/7/1/118.abst
ract;
http://ndt.oxfordjournals.org/content/13/5/1176.
abstract. Thank you for your consideration.



Please provide a LBTEST and LBTESTCD for III             TBD
Anti-Factor Xa activity as this parameter is
missing from the pick list yet units for its
reporting are present in the UNIT terminology.
Please consider LBTEST =Anti-Factor Xa
activity LBTESTCD = ANTIFXA


Please consider amending definition from "A        III   TBD
measurement of the triple phosphate crystals
present in a biological specimen." to "A
measurement of tyrosine crystals present in a
biological specimen." Thank you. 09-Feb-
2011/APZ
In UNIT, mg/mL and g/L are synonyms of             III   TBD
kg/m3 (C71620). In PKUNIT, mg/mL is a valid
submission value and kg/m3 is a synonym of it.
LAB data fits better within the PKUNIT codelist
in relation to the level of unit. For example, you
would always express Hemoglobin
concentration in g/L, never in kg/m3. Has any
consideration been given to creating a LBUNIT
codelist for laboratory data in order to make the
submission value more in keeping with the data
itself?
I know I've asked a similar question back in      III   TBD
Nov 2010 but wanted to add to it. Existing unit
terms seem to make use of 'thousand', billion'
or'million' rather than using a '10 to the power
of'(10^) convention which is used extensively in
laboratory data. This makes for very long unit
codes, especially; 10^4 = ten thousand; 10^5 =
hundred thousand; 10^9 = thousand million =
US Billion; 10^12 = million million = UK Billion;
As you can see, Billion is not the same in UK
and US terminology. This makes using the
word very risky in relation to lab data as both
10^9 and 10^12 are used routinely. Therefore I
would like to request use of 10^ or 10*
terminology be added to the terminology list.



Request addition of these two new terms that III        TBD
are not currently available in the Anatomical
Location codelist.
CDASH terminology spreadsheet - SUNCF          I        TBD
codelist code for C25471 and C25627. Copy-
paste error. Change codelist code to C83004 in
column B of spreadsheet.

I am not sure whether the published               II    TBD
terminology can be changed, but if it can, then
this is definately a candidate for change.Right
now, to make the difference in my company
dictionary, I am going to have to create
AMYLASET to represent total amylase and
differential it from the CDISC AMYLASE
(pancreatic amylase).....and this is really going
against the CDISC terminology principles.



                                                   II   TBD


This discussion came from a SHARE meeting III           TBD
at FDA. All of the existing ECG tests on the
EGTEST codelist have numeric result values.
However, there are no EGTEST that have
results that can be reported as character
values and/or that correspond to the published
EGSTRESC codelist. Suggest to add a test'
ECG Abnormality' to the EGTEST codelist
which can be used as the test value for all of
the corresponding EGSTRESC codelist values.
See page 128 of the SDTM IG for further
clarification of the issue.
All modifications and additions are in file from   II/III   TBD
Dennis Noe.



These --TEST values are longer than 40 chars, II            TBD
which violates SDTM principles. Should be
shortened to <= 40 chars.



Consistency of related terms will enable better II          TBD
edit checking for CT items.




Related to this request: the CDISC Synonym      II          TBD
values for LBTESTCDs = VITB9 (C74676),
VITB1 (C74896), VITB2 (C74898), VITB3
(C74899) should also have their word order
reversed. The Vitamim should be mentioned
first, then a semicolon, then to chemical name.
This would make these values consistent with
the CDISC Synonym values in the
corresponding LBTEST rows.

We are using this as part of our Vital Signs       III      TBD
Panel for some studies. This is also called
SaO2 or Pulse Oxygen Saturation. I checked
the 2011 Terminology list and did not find this.
Sorry if this is a duplicate request

C49697 - Change definition for LENGTH to           III      TBD
Planned length of observation for a single
subject.
We are currently using Holter Monitor data is      II       TBD
some Phase 1 studies. We would like to
identify / differentiate the sources of data where
we use standard 12 Lead ECGs along with
Holter monitors for the same subjects in the
dataset
Add BD as a synonym to BID to be compliant II               TBD
with CDASH

C71205-add mcg/day as a synonym; C71211-           II       TBD
add mcg/min as a synonym; C67406-add
mcmol/day as a synonym; C48152-addition of
mcg to SY list. - For compliance with CDASH
and SDTM-UNIT codelist

Add SYs of Hour; hr - For compliance with          II       TBD
CDASH and SDTM-UNIT codelist
SY of hr needs to be added - For compliance       II    TBD
with CDASH and SDTM-AGEU codelist

Lowercase the word 'per' in the codelist name     I     TBD
column for concepts on rows 72-78.

Incorrect Codelist Name for concept C25473        I     TBD


Lowercase the word 'per' in the codelist name     I     TBD
synonym.

                                                  III   TBD




No current frequency available in the controlled III    TBD
terminology
Transferrin saturation: Transferrin saturation,         TBD
abbreviated as TSAT and measured as a
percentage, is a medical laboratory value. It is
the ratio of serum iron and total iron-binding
capacity, multiplied by 100.
                                                 III
Reticulocyte hemoglobin content: A Test for             TBD
Diagnosing Iron Deficiency. Reticulocyte
hemoglobin content (CHr)
measures the amount of hemoglobin in
reticulocytes.                                   III
Serum calcium and phosphorus product                    TBD
                                                 III
Incorrect Mapping                                       TBD
                                                 I
                                                 III    TBD

Requesting addition of 1XWK to capture the        III   TBD
concept of once per week. Using this to
capture the number of times a subject
exercises in a week.
Requesting addition of 5XWK to capture the        III   TBD
concept of 5 times per week. Using this to
capture the number of times a subject
exercises in a week.
Requesting addition of 6XWK to capture the        III   TBD
concept of 6 times per week. Using this to
capture the number of times a subject
exercises in a week.
Requesting addition of 7XWK to capture the       III    TBD
concept of 7 times per week. Using this to
capture the number of times a subject
exercises in a week.
Should be added to the CDISC - SEND only         III    TBD
Control Terminology list. Domains that could
utilize the term. are OM, MA, and MI. It is a
joint that was collected in one of our company's
study and wil be submitted to the FDA.


The specificity of location is needed for         III   TBD
ophthalmic medication administration and
vaccination studies.




Can we please either have ambient added as a III        TBD
synonym of Room Temperature or retire the
concept of Room Temperature and just have
Ambient or have Ambient as an additional term
to Room Temperature....Ambient meaning the
specimen is that the temperature of it's
surroundings.

New terms required to map units encountered III         TBD
on a clinical study to SDTM units controlled
terminology.
Additional terms required to map vital signs    III     TBD
encountered on a clinical study to apppropriate
SDTM terminology controlled terms.




Additional terms required to map lab test data III      TBD
collected during a clinical study to apppropriate
SDTM terminology controlled terms.
This request is for the addition of VS TESTCD III       TBD
& VSTEST as part of the CDISC/NINDS
Parkinson's Disease standards. The NINDS
Working Group created these new VS tests as
part of their Common Data Elements for
Parkinson's Disease. The NINDS CDE's form
the basis for the CDISC data standards on this
Disease Area project. These 3 fields are
additonal body measuements on the Risk
Factor Questionnaire on Height & Weight. This
was a questionnaire developed by an
epidemiology working group sponsored by the
Collaborative Centers for Parkinson-s Disease
Epidemiology Research. It has been validated
and is now available in eleven languages.


Typo in Definition. Change definition to: A             TBD
measurement of the cancer antigen 19-9 in a
biological specimen.                            I
This request is for the addition of a new Dose          TBD
Frequency value as part of the CDISC/NINDS
Parkinson's Disease standards. The NINDS
Working Group created this value as part of
their Common Data Elements for Parkinson's
Disease to capture Non-PD Medications . The
NINDS CDE's form the basis for the CDISC
data standards on this Disease Area project.
                                                III
Change existing Def to make it useable across II        TBD
SDTM and SEND. Existing: Those units of time
that are routinely used to express the age of a
person. (NCI) CHANGE TO: Those units of
time that are routinely used to express the age
of a subject.

This request is for the addition of a new Dose    III   TBD
Frequency value as part of the CDISC/NINDS
Parkinson's Disease standards. The NINDS
Working Group created this value as part of
their Common Data Elements for Parkinson's
Disease to capture Substance Usage from
their Non-Prescribed Drug History CRF . The
NINDS CDE's form the basis for the CDISC
data standards on this Disease Area project.

Add a new SDTM LBTEST term of Interleukin         III   TBD
2 Receptor. Add a new SDTM LBTESTCD of
INTLK2R.
Caplet is a dosage form used in our drug          III   TBD
studies.
Please add the unit L/h to the Unit codelist.     III   TBD
Currently available in the PK Unit codelist but
also need this term in the Unit codelist.
This request matches the recently posted       II     TBD
CDER document "CDER Common Data
Standards Issues Document" UCM254113.
Here the advice for MedDRA Terminology is
"When using MedDRA for adverse events and
medical history terms, sponsors should exactly
follow the spelling and case of the MedDRA
terms." see page 5. Currently the terms are
published in complete upper case and this
conflicts with this advice and communication
we have received from a reviewing division at
FDA.
                                               III    TBD



                                                III   TBD

Please change 'U' to 'UNKNOWN' (C17998) so II         TBD
that it is consistent with corresponding values
in 'Action Taken with Study Treatment'
'Outcome of Event', 'Ethnic Group', 'Route of
Administration', 'Frequency', and 'Microbiology
Susceptibility Testing Result Category.


Please change 'U' to 'UNKNOWN' (C17998) so II         TBD
that it is consistent with corresponding values
in 'Action Taken with Study Treatment'
'Outcome of Event', 'Ethnic Group', 'Route of
Administration', 'Frequency', and 'Microbiology
Susceptibility Testing Result Category.


Please change 'U' to 'UNKNOWN' (C17998) so II         TBD
that it is consistent with corresponding values
in 'Action Taken with Study Treatment'
'Outcome of Event', 'Ethnic Group', 'Route of
Administration', 'Frequency', and 'Microbiology
Susceptibility Testing Result Category.


There is no frequency that would indicate per III     TBD
year.
For packs of cigarettes smoked. The term      III     TBD
"PACK" is used in the SU example on page 93
of the SDTM implementation guide (version
3.1.2) but does not appear in the UNIT code
list.

				
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