Project Scope Nonclinical ts.xpt files that are typically created and submitted to the FDA. Problem Statement - No one wants to be responsible for a rejection.
- Existing validation tools provide checks for the TS file against the FDA TRC, but because these tools are not produced in cooperation with the FDA and differ from FDA proprietary systems, there may still be significant concern about rejection at the time of submission. In addition, not all tools provide checks against the Study Tagging File and eCTD section numbers that are also required by the TRC.
- Only sponsor organisations will receive warning messages between now and Q4, AND only if they have a submission between now and then. Additionally, this project can test certain cases that are common in industry that are not present in every submission.
- The FDA has indicated they are willing to receive test submissions, but if we all test independently, this will be a substantial burden on the FDA.
- An organised test will enable a broader SEND community to understand what will pass using the existing public FDA system for test sample submission and will enable PHUSE to be seen as a critical partner in resolving submission questions related to FDA standards.
Problem Impact With this project, PHUSE will enable industry to evaluate the factors leading to acceptance/rejection and to confidently produce TS files that have been shown to avoid rejections once the TRC go into effect, if the project is launched quickly and delivers soon enough. |