Home Forums Where do I file…. ? CDISC Deliverables

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    • #4169
      Elisa Young

      I would appreciate recommendations regarding the filing of CDISC deliverables, including:
      * SDTM Datasets (These are rarely the raw datasets as suggested in the current model)
      * ADaM Datasets
      * SDTM and ADaM Data Review Guides
      * SDTM and ADaM DEFINE.XML files

    • #4554
      jane Forrest

      Hi there, I would file ADaM Datasets in [11.03.05 Interim Analysis Datasets] or [11.03.09 Final Analysis Datasets] depending on the anlysis. I believe that ‘Interim analysis’ will be updated to ‘Interim or Other anlaysis’.
      SDM and ADaM Data Review Guides – I would argue these are probably not TMF deliverables unless study specific. In which case, I would file in [11.03.01 Data Definitions for Analysis Datasets]. Same artifact for the Define.xml files. I think there is a gap in the model for SDTM datasets as you point out. They are not always ‘raw datsets’ or ‘analysis datsets’. I have proposed they are added as a new artifact to the Data Management zone (as no Stats analysis involved in conversion to SDTM). However, I dont think this is going to be accepted as a change request, Hope this helps.

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