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
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.