Webcast | Virtual

Event Title

Webinar: The FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019

November 22, 2019

Date:: November 22, 2019
Time:: 1:00 p.m. - 2:30 p.m. ET

This on-demand webinar is FREE. This webinar was recorded on November 22, 2019.

ABOUT THIS WEBINAR

FDA experts provide an overview of recent updates made to FDA’s Study Data Technical Conformance Guide v4.4 – recorded on Friday, November 22, 2019.

The Study Data TGC provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog. The TCG supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data and provides technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs.

TOPICS COVERED

Updates since March 2019 sdTCG
Using the simplified TS.xpt
Section 8.2.2 specifics
- There will be detailed examples of the intricacies of using the simplified TS.xpt with nonclinical submissions.

Intended Audience

Anyone involved in the collection, preparation or submission of study data to FDA.

FDA SPEAKERS

Helena Sviglin
Study Data Technical Conformance Guide, Chair
Office of Strategic Programs (OSP) | CDER | FDA

Heather Crandall
Electronic Submissions Team
Office of Business Informatics (OBI) | CDER | FDA

Stephanie Leuenroth-Quinn
Nonclinical Representative for Data Standards Development
Office of New Drugs (OND) | CDER | FDA

FDA RESOURCES

Event Materials

Title	File Type/Size
The FDA Study Data Technical Conformance Guide v4.4 Webinar Slides	pdf (1.16 MB)