Phuse US Connect
Future Clinical Data Submission Standards: CDISC, FHIR, OMOP, or Hybrid Model
Jeffrey Abolafia, Director of Product Innovation
Guidance Beyond the SDTM Implementation Guide
Michael Beers, Principal Consultant & Kristen Kelly, Senior Principal CDISC Consultant
A common misconception among preparers of SDTM data seems to be that it is sufficient to just follow the SDTM Implementation Guide when creating the datasets. The truth is that it is more complicated than that. A preparer of SDTM datasets needs to be aware of all the industry guidance available when preparing for regulatory submission, from CDISC and the regulatory agencies, but also from other organizations as well. This presentation will discuss some of the lesser-known guidance in the industry and why they should be referenced, as well as some of the impacts of not using these documents in the creation of SDTM datasets.