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*Short Course requires separate registration

Registration: 7:30 – 8:30AM

In this session, FDA, CDER will provide an update on topics focused on metrics and typical issues from received study data. Study Data Standards listed in the FDA Data Standards Catalog are required for clinical and nonclinical studies that started after December 17, 2016 (for ANDA, NDA, and BLA) or December 17, 2017 (for Commercial IND). Through the technical rejection process, FDA can reject an application because of its technical deficiencies, based on the severity of the eCTD validation criteria.

Based on the Technical Rejection Criteria for Study Data (TRC) conformance analysis conducted by FDA on submissions that contain study data that received by the Agency, FDA updated the Study Data Technical Conformance Guide (TCG) and TRC to provide more clarification on the validation criteria. FDA also developed supporting tools to help Industry meet study data requirements, including the Study Data Self-Check Worksheet.

Presenters will demonstrate the use of the fillable Study Data Self-Check Worksheet, and illustrate its ability to identify potential rejectable errors prior to submission to FDA. The learning session will also introduce a web application developed by a PhUSE working group that help sponsors create required Simplified TS Files (ts.xpt).

Learning objectives

At the conclusion of this session, participants should be able to:
  • Recognize FDA requirements for Standardized Study Data Submission
  • Analyze the Study Data Technical rejection criteria validation logic
  • Utilize tools available for preparing the Study Data submission