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					Release   Request    Change   NCI Code   CDISC Term   CDISC       Change Summary
Date      Code       Type                Type         Codelist
2010-07        28626 II       C80360     SY           SDTM-       Change SY of Somatotrophin
                                                      LBTEST      in SDTM-LBTEST codelist so
                                                                  that SDTM-LBTEST and SDTM-
                                                                  LBTESTCD synonyms of
                                                                  C80360 are identical.

2010-07       28691 II        C54431     SY           SDTM-       In LBTEST and LBTESTCD
                                                      LBTESTCD    codelist add synonym of
                                                                  microalbumin to albumin.
2010-07       28705 II        C49610     Def          SDTM-       Change definition of Subject
                                                      DOMAIN      Characteristics domain in
                                                                  DOMAIN codelist.



2010-07       28862 II        C74710;    PT, Def      SDTM-       Removal of the word 'surface'
                              C74712                  LBTEST      from the CDISC PTs and Defs
                                                                  of Hepatitis C Virus Surface
                                                                  Antibodies and Hepatitis A
                                                                  Virus Surface Antibodies

2010-07       28991 II        C81971     SY           SDTM-       Removal of synonym of
                                                      LBTESTCD;   Immunoglobulin G
                                                      SDTM-
                                                      LBTEST
2010-07       28992 II        C82013     SY           SDTM-       Request to add Fibrinogen
                                                      LBTESTCD;   Degradation Products as a
                                                      SDTM-       Synonym of Fibrin
                                                      LBTEST      Degradation Product in SDTM-
                                                                  LBTEST and SDTM-LBTESTCD
                                                                  codelist.
2010-07       28246 III       C82043     PT           SDTM-       Vascular Epithelial Growth
                                                      LBTEST      Factor please correct to the
                                                                  most common test name
                                                                  Vascular Endothelial Growth
                                                                  Factor
2010-07       28340 III       NEW        PT           SDTM-       FASTING BLOOD GLUCOSE
                                                      LBTESTCD;   (SST)
                                                      SDTM-
                                                      LBTEST
2010-07       28342 III       NEW        PT           SDTM-       Addition of terms
                                                      LBTESTCD;   Erythrocytes; Red Blood Cells
                                                      SDTM-       in Urine; Leukocytes; White
                                                      LBTEST      Blood Cells in Urine to LBTEST
                                                                  and LBTESTCD codelist.

2010-07       28343 III       NEW        PT           SDTM-       Addition of terms Bilirubin in
                                                      LBTESTCD;   Urine and Blood in Urine to
                                                      SDTM-       LBTEST and LBTESTCD
                                                      LBTEST      codelist.
2010-07   28658 III   C74724,   PT, Def   SDTM-       In LBTEST and LBTESTCD
                      C74725,             LBTESTCD    codelist, remove PCR from PT
                      C74726,                         and Definitions of HAVPCR,
                      C74727                          HBVPCR, HCVPCR, HIVPCR.


2010-07   28792 III   NEW       PT        SDTM-     Request to add either
                                          SPECTYPE  Nasopharynx or
                                                    Nasopharyngeal to the SDTM
                                                    specimen type codelist.
                                                    Nasopharyngeal swabs are
                                                    frequently used when testing
                                                    for various viruses, e.g.
                                                    Adenovirus, Rhinovirus,
                                                    Influenza, etc.
2010-07   28863 III   NEW       PT        SDTM-FREQ Addition of OCCASIONAL to
                                                    SDTM-FREQ codelist.


2010-07   28927 III   NEW       PT        SDTM-FRM Addition of TABLET, OVER
                                                   ENCAPSULATED to SDTM-FRM
                                                   codelist.




2010-07   28983 III   C81975    SY        SDTM-       Addition of synonym to
                                          LBTESTCD;   Antimitochondrial Antibody in
                                          SDTM-       SDTM-LBTEST and SDTM-
                                          LBTEST      LBTESTCD codelists.

2010-07   28984 III   C82032    SY        SDTM-       Addition of synonym to ProB-
                                          LBTESTCD;   type Natriuretic Peptide in
                                          SDTM-       SDTM-LBTEST and SDTM-
                                          LBTEST      LBTESTCD codelists.

2010-07   28985 III   C80160    SY        SDTM-       Addition of synonyms to
                                          LBTESTCD;   Complement Total in SDTM-
                                          SDTM-       LBTEST and SDTM-LBTESTCD
                                          LBTEST      codelist.
2010-07   28986 III   C82038    SY        SDTM-       Addition of synonyms to Type
                                          LBTESTCD;   I Collagen C-Telopeptides in
                                          SDTM-       SDTM-LBTEST and SDTM-
                                          LBTEST      LBTESTCD codelist.
2010-07   28987 III   C81984   SY   SDTM-       Addition of synonym to
                                    LBTESTCD;   Heterophile Antibodies in
                                    SDTM-       SDTM-LBTEST and SDTM-
                                    LBTEST      LBTESTCD codelist.
                                                Heterophile Antibody Mono
                                                screen
2010-07   28989 III   NEW      PT   SDTM-       Addition of 'Partial Pressure of
                                    LBTESTCD;   Arterial Oxygen' to SDTM-
                                    SDTM-       LBTEST and SDTM-LBTESTCD
                                    LBTEST      codelist.

2010-07   28988 III   NEW      PT   SDTM-       Addition of term Soluble
                                    LBTESTCD;   Vascular Cell Adhesion
                                    SDTM-       Molecule 1 to LBTEST and
                                    LBTEST      LBTESTCD codelist.
Original                                      New

SY: Somatotropin; Growth Hormone              SY: Somatotrophin; Growth Hormone




---                                           SY: Microalbumin


Def: The subject characteristics domain is      Def: The subject characteristics
for data not collected in other domains that domain is for data not collected in
is subject-related. Examples: subject initials, other domains that is subject-related.
other race details, eye color, childbearing
status, etc.

PT: Hepatitis C Virus Surface Antibodies; PT: PT: Hepatitis C Virus Antibodies; PT:
Hepatitis A Virus Surface Antibodies          Hepatitis A Virus Antibodies




SY: Gamma Globulin                            ---



---                                           Request Denied




PT: Vascular Epithelial Growth Factor         PT: Vascular Endothelial Growth Factor




---                                           Request Denied



---                                           Request Denied




---                                           Request Denied
PT: HAVPCR, HBVPCR, HCVPCR, HIVPCR;           PT: HAVVLD, HBVVLD, HCVVLD,
Def: A measurement of the X viral load in a   HIVVLD [HAV Viral Load; HBV Viral
biological specimen using polymerase chain    Load; HCV Viral Load; HIV Viral Load];
reaction.                                     Def: Def: A measurement of the X viral
                                              load in a biological specimen.

---                                           Request Denied




---                                           C-code C64954 ; CDISC PT:
                                              OCCASIONAL; CDISC Def: Not occurring
                                              regularly or at short intervals.

---                                           Request Denied




---                                           SY: Mitochondrial antibody




---                                           SY: N-terminal pro-Brain Natriuretic
                                              Peptide



---                                           SY: CH50; Total Hemolytic
                                              Complement


---                                           SY: Type I collagen X-linked C-
                                              telopeptide
---   Request Denied




---   Request Denied




---   PT: Soluble Vascular Cell Adhesion
      Molecule 1 / SVCAM1; Def: A
      measurement of the soluble vascular
      cell adhesion molecule 1 in a biological
      specimen.
Justification for Denied Request




These are not synonymous. Thrombin
converts soluble fibrinogen into insoluble
fibrin. They are coded separately in Thesaurus
since they are two separate proteins.




Fasting Status goes into the variable LBFAST.
Term will not be added.


The specimen does not belong in the term but
should go into LBSPEC.




The specimen does not belong in the term but
should go into LBSPEC.
Swab would be the collection method, (in
suppqual). 'Nasopharynx' C12423 is the
location and the specimen is possibly
"mucus". No change




Based on expert terminology resources we
will not 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".
Will not add new test. Should be mapped to
HTPHAB




Will not add new test. Arterial is the location.

				
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posted:11/27/2011
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