When preparing SDTM datasets for submission, further guidance may be needed to fill in some of the gaps that are not outlined in the SDTM Model or the SDTM Implementation Guide (SDTMIG). In addition, regulatory requirements that may differ from what is in the CDISC standards must also be followed.
So where can you find the clarifying information you might need?
Substantial guidance has been published from many different sources (e.g., CDISC, regulatory authorities, etc.) to aid implementers in preparing submission deliverables. Join Senior Principal CDISC Consultant Kristin Kelly and P21's Director of Consultative Services Michael Beers to learn where you can find the answers you need for a smoother submission and review:
CDISC Guidance
PHUSE Guidance
Regulatory Guidance
Other Guidance
Impact of Disregarding Available Guidance