Public | Virtual
Event Title
FDA Study Data Technical Rejection Criteria (TRC): What you need to know!
May 21 - 27, 2021
Event Title
FDA Study Data Technical Rejection Criteria (TRC): What you need to know!
- Date:
- May 21 - 27, 2021
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.
TOPICS
- 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
FDA PRESENTERS
- 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
INTENDED AUDIENCE
- Regulatory affairs professionals
- Consultants working on eCTD submissions containing study data
- Statisticians and statistical programmers