- May 21, 2021
1:00 PM - 2:30 PM ET
FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding when a submission containing study will be subject to these study data eCTD validations. This webinar will provide an overview of the TRC and walk through resources currently available to help the sponsor/applicant determine if their submission is subject to these eCTD validations, creation of a simplified TS.XPT, and frequently asked questions.
- Technical Rejection Criteria (TRC) Background and What’s New
- Overview of the TRC and Effective Date
- TRC Warning Metrics
- CDER SEND Requirements and TRC
- Preparing a Study Using the Self-Check Worksheet
- Creating a Simplified TS.XPT File
- Frequently Asked Questions
- Jiang Xu, Senior Health Informatics Officer, Office of Business Informatics | CDER
- Lina Cong, Senior Health Informatics Officer, Office of Business Informatics | CDER
ADDITIONAL FDA PANELISTS
- Jonathan Resnick, Project Management Officer, Office of Business Informatics | CDER
- Stephanie Leuenroth-Quinn, Associate Director (Acting), Office of New Drugs | CDER
- Mark Gray, Senior Project Manager, Office of the Director | CBER
- Regulatory affairs professionals
- Consultants working on eCTD submissions containing study data
- Statisticians and statistical programmers
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
- has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation 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.
- has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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