SDTM Trial Summary (TS) domain is essential for regulatory submission and is part of FDA rejection criteria.
TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical Conformance Guide (TCG), FDA Technical Rejection Criteria, and numerous terminologies. Interpretation of validation results for TS can also be difficult. In this webinar, Kristin Kelly discusses the minimum set of parameters that should be included in TS and reviews common implementation issues.
SUPPQUAL datasets represent the non-standard variables in SDTM tabulation data. However, there is a lack of implementation metrics across the industry to understand the actual usage of SUPPQUAL datasets. In this webinar, Sergiy Sirichenko summarizes metrics from many studies and sponsors to produce an overall picture.
Our recent webinar Confusing Validation Rules Explained sparked lots of follow-up questions from you. We are addressing those questions in a series of posts. In this edition, we will clarify the best practices when mapping data for screen failure, not assigned, and not treated subjects. We will also help by describing the most effective ways to respond to these situations.
Define.xml is "arguably the most important part of the electronic dataset submission for regulatory review," according to The FDA’s Technical Conformance Guide. It helps reviewers gain familiarity with study data, its origins and derivations, as well as sponsor-specific implementation of CDISC standards. In addition to the define.xml, the Technical Conformance Guide also asks that sponsors submit a stylesheet. A stylesheet transforms the define.xml into a human readable structure.
With the latest Pinnacle 21 Enterprise 3.4 release, we continue to bring efficiencies to your data standardization and compliance efforts. This release features a number of new enhancements and compliance checks that you have been asking for. This release also marks the formal roll-out of our new customer-centric initiative and a dedicated Customer Success Team.
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