- November 22, 2019
1:00 PM - 2:30 PM 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.
- 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.
- Anyone involved in the collection, preparation or submission of study data to FDA.
Study Data Technical Conformance Guide, Chair
Office of Strategic Programs (OSP) | CDER | FDA
Electronic Submissions Team
Office of Business Informatics (OBI) | CDER | FDA
Nonclinical Representative for Data Standards Development
Office of New Drugs (OND) | CDER | FDA
- Study Data Technical Conformance Guide v4.4
- Study Data Standards Resources Website
- Technical Rejection Criteria for Study Data revised 10/03/2019
- Self-check worksheet for study data preparation
- Instructions to self-check worksheet for study data preparation
- Study Data for Submissions to CDER and CBER
|The FDA Study Data Technical Conformance Guide v4.4 Webinar Slides||pdf (1.16 MB)|