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  4. Webinar: The FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019 - 11/22/2019
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Webcast | Virtual

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

November 22, 2019
1:00 PM - 2:30 PM ET

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


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.


  • 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.


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


Event Materials

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