Pre-conference Workshop: Data Requirements for an FDA Submission
Sunday, September 29, 2024 1:30 PM to 6:00 PM · 4 hr. 30 min. (America/New_York)
Room E
Workshop
Clinical Data Competencies & Cross-Functional InteractionsTechnology & Data PlatformsRegulations & StandardsClinical Trial Operations
Information
Accessible only for registered participants.
This workshop is an depth review of the data and document requirements for an FDA submission as it pertains to module 5. Some topics covered will be metadata submission guidelines, technical conformance guide, submission review from and FDA Reviewer's perspective and the review tools the FDA use. We will also cover ongoing impactful projects such as Dataset JSON, M11, DDF and USDM. If you ever wanted to know what goes into an FDA submission and how its reviewed, this workshop is for you.
Learning Outcomes
Participants should know the purpose of the technical conformance guide and a basic understanding of how to use itParticipants should be able to discuss the data and document requirements at the individual study levelParticipants should have an understanding of the the tools used by the FDA during a review and their purposeParticipants should have an understanding of the SDTM and ADaM and their differences as they relate to a submission
Level
Intermediate
Target Audience
Data ManagementProject ManagementProgramming/Statistics
CEUs
0.4
