On August 5, 2016, FDA released a new version of the Study Data Technical Conformance Guide version 3.1 (Guide). This Guide provides technical specifications, recommendations, and general considerations on how to submit standardized electronic study data using FDA-supported data standards located in the FDA Data Standards Catalog (Standards Catalog). As always, anyone who is going to be involved in submission data preparation should study the entire Guide thoroughly. We would like to discuss one important issue that is often overlooked, which is the decision to include Trial Design Domains in an e-submission.
Emphasizing Trial Design Model in SDTM and SEND
FDA emphasizes the importance of Trial Design Model (TDM) which includes Trial Arms, Trial Elements, Trial Visit, Trial Inclusion/Exclusion Criteria, Trial Summary and Trial Disease Assessment. FDA strongly recommends that sponsors should include Trial Summary (TS) even for legacy studies. What is the unique about TS is that the study start date (SSTDTC in TS.TSPARMCD) in the TS domain will determine whether a given study needs to use a particular data standards as specified in Standards Catalog. The requirement for providing TS domain for NDA/BLA was also made clear by FDA at the 2016 FDA/PHUSE Computational Science Symposium (CSS). Therefore, it is a must-have, not a nice-to-have item. In SEND submission, all the Trial Design domains should be included as well.
Data for building Trial Design Domains may not in the EDC raw data
We have noticed that one common reason for people to push back on creating TDM is that the source data are not in the EDC database. Some are actually from protocol and sometimes it is unclear whose responsibilities it is to build these domains. At Clindata Insight, when we review CRO deliverables as part of our CRO Oversight consulting service, we pay special attention to check the deliverables against FDA’s requirements such as what is included in this Guide. We strongly urge sponsor companies to use this Guide to evaluate their CRO’s knowledge of supporting CDISC compliant submission. A quality vendor should have thorough understanding of the Guide and provide solid adherence to the Guide.
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