- November 22, 2019
1:00 PM - 2:30 PM ET
This webinar is FREE.
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
There is a two-week deadline to obtain the certificate of attendance and complete the event survey. Certificates are available only for those who attend in real-time.
- has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
- is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. Candidate must provide documentation of participation.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- ACRP provides research-specific continuing education for the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
Please contact email@example.com for all technical questions.
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|The FDA Study Data Technical Conformance Guide v4.4 Webinar Slides||pdf (1.16 MB)|