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									CD12 - Implementing metadata standards at the protocol level      04 October 2012




                                 Implementing
                                      metadata
                               standards at the
                                  protocol level
                                                                 Phuse Berlin
                                                                October 2010
                                                                 Annabel Acs
                                                        aacs@novonordisk.com
CD12 - Implementing metadata standards at the protocol level   04 October 2012   Slide no 2
    CD12 - Implementing metadata standards at the protocol level   04 October 2012   Slide no 3




Standard


 Technology


                        Process
                                       CD12 - Implementing metadata standards at the protocol level           04 October 2012                      Slide no 4


                The standards and technology at NN
                                                               Protocol
                                 CRF                          Standards
                CRF
                CRF           Standards
                CRF                                                                                           Submission
  Date:           / /
                                                                                                               Standard
  Abc                   x:   y:
   :
   Qwr:

                                                                                                      CDISC SDTM
                                                                                                      Data Domain: CDISC ADaM
                                                                                                                   PE
                                                                                                      <XML>                Data Domain: ADPE
                                                                                                      .…                   <XML>
 Standard                                                                                                                  .…

DCM/DVGs
                                                                                                                  Std. EOT
                                       Subject
                                                           CDW
                OC                        Visits
                                                      Numeric Findings      Events   (AE/Hypo/x)                  XXCgfg hghj dklædfjkll sdfkf jklsd
                                                                                                                  -----------------------------------

        Table   Responses                              Categoric Findings       Interventions                     Xxxx
                                                                                                                    Xxx       1223   456. 7789.0
          Table                           Elements                                                                  Xxxx      1223   456. 7789.0
                                                                                                                    Xxxx      1223   456. 7789.0




                             Mapping                                                               Standard
 Standard                                                                                           Reports
                              rules                 Standard
 Mappings
                                                   Code Values
          CD12 - Implementing metadata standards at the protocol level         04 October 2012   Slide no 5




The process supporting standards
and technology at NN




 Trial                       Data                               Programm
                                                                   ers
Managem                  Managem                                         and
  ent                      ent
                                                                 Statisticia
                                                                     ns
       PMT
       technology

• Protocol Metadata
  Template (Excel)
   •   Inexpensive
   •   Easy to use
   •   Easy to modify
   •   Familiar to
       everyone
        CD12 - Implementing metadata standards at the protocol level    04 October 2012   Slide no 8



                                                                       WBC
Protocol                       Leucocytes
Metadata
Template                                                                     White
standards                                                                    Blood
                                                                              Cells
             CD12 - Implementing metadata standards at the protocol level   04 October 2012   Slide no 12




Trial Design defined in CDW-O with
 protocol attributes
            CD12 - Implementing metadata standards at the protocol level     04 October 2012   Slide no 16




The process supporting the
standards and technology



 Protocol                                       Protocol
                                                Metadata
  Draft                                         Template




                                                                  Protocol
                                                                       1.0
              CD12 - Implementing metadata standards at the protocol level   04 October 2012   Slide no 17




        The process supporting the
        standards and technology


Trial            Data                                Program                         Medical
Mng              Mng                                 mers and                        Writers
                                                     Statistici
                                                        ans



  •Time
  •New tool
  •Admin.
                   CD12 - Implementing metadata standards at the protocol level   04 October 2012   Slide no 18




            SOPs

Training                   Mng Attn.
                                                     Improving the
                                                     process…
              New
            Processes




    Trial             Data                                Program                         Medical
    Mng               Mng                                 mers and                        Writers
                                                          Statistici
                                                             ans
                                    CD12 - Implementing metadata standards at the protocol level        04 October 2012   Slide no 19




  Vision for future Clinical System Architecture

                                                         Portal
                                       Other
      eRandom             Coding      eRecords
   CTMS        IWRS       EDC         LAB                Safety         SCE         BI        cBI       PACT       eCTD




                                                                                                                                  Training & Processes
Dictionaries
                 Set Up               Conduct                         Analyze                             Publish


eStandard
eProtocol                                      Clinical                       Enriched                   Submission
eDCS                  Metadata
          Set-up                   Verify    Source Data Enrich                Clinical       Analyse     Outputs
eSPS                  Repository
                                              Repository                        Data                     Repository
ePSPS                                                                        Repository

                                                    Process Data Repository

                                                                                              Master Data

								
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