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

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 PM - 2:30 PM ET

 

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Watch Recording Now  View Slides

 

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.

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

  1. Study Data Technical Conformance Guide v4.4
  2. Study Data Standards Resources Website
  3. Technical Rejection Criteria for Study Data revised 10/03/2019
  4. Self-check worksheet for study data preparation
  5. Instructions to self-check worksheet for study data preparation 
  6. Study Data for Submissions to CDER and CBER

CONTINUING EDUCATION

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.

This course:

  • 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.

QUESTIONS

Please contact info@sbiaevents.com for all technical questions.

TECHNICAL INFORMATION

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit: Adobe Connect Diagnostic Test


Event Materials