This project must publish its conclusions in time for industry to be prepared for the implementation of the TRC, which is planned for September 15. If industry needs two months to act, this project plans to complete the following by July 15: - Form a team to decide upon the scenarios to test, perhaps including:
- Supply TS with a valid study start date but without a TSVALNF column (following SEND 3.0 rules).
- Supply “NOT APPLICABLE” for the TSVALNF.
- Supply “NA” in the TSVALNF for the study start date record and a SPREFID with the Study ID that matches the Study Tagging File’s Study ID.
- Supply a year-only date for the study start date with “DERIVED” in the TSVALNF.
- Supply a SEND 3.1-compliant typical TS file without the full SEND package.
- Use the correct dataset name in the ts.xpt file/use an incorrect dataset name within the ts.xpt file.
- Get a volunteer to create the eCTD.
- Get volunteers to create the datasets.
- Get a volunteer to submit the eCTD to the test gateway and share the results with the team.
- Submit to the FDA following the instruction we received from Ethan Chen (Division of Data Management Services & Solutions, Office of Business Informatics, CDER) on May 27, 2021:
- Use the current Sample Data Submission path processing TRC Sample Submission.
- The submission should be in eCTD format.
- Application number: Use the real application number or the TRC Sample Submission from the PHUSE Nonclinical Topics Working Group.
- Test request and application type should be the TRC Sample Submission from the PHUSE Nonclinical Topics Working Group.
- Include the TRC Sample Submission from the PHUSE Nonclinical Topics Working Group in the cover letter.
- Wait for the FDA response.
- The team publishes a summary document, the test submission(s), and the results (e.g. the FDA’s TRC warning notice), enabling industry to compare to their submissions and ascertain a likely outcome.
| A detailed timeline will follow shortly with a target end date of September 2021. |