Project Scope

Nonclinical ts.xpt files that are typically created and submitted to the FDA.

Problem Statement

  1. No one wants to be responsible for a rejection.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

Project LeadsEmail
Michael DeNieumichael.deNieu@covance.com
William Houserwilliam.houser@bms.com

Paula Rowley (PHUSE Project Assistant)

paula@phuse.global 

CURRENT STATUS Q22021

Project concluded, see final deliverables below. 
Project MembersOrganisation
Anthony FataBooz Allen Hamilton
Christopher Elery Pfizer
Christy Kubin CRL
Gen Sato Eisai
Janessa Pierce Merck
Joseph HorvathBMS
Kathryn Brown Sanofi
Kishore PothuriVita Data Sciences
Lalit Verma Janssen Research & Development
Lou Ann Kramer CDISC
Michael Rosentreter Bayer
Project MembersOrganisation
Palani Senthilkumar Xybion
Pushpak BoraInstem
Rick Thompson Janssen Research & Development
Sandra Krogulski BMS
Sonja Geuens Janssen Research & Development
Stefano Gaudio Roche
Wenxian Wang BMS
Objectives & DeliverablesTimelines

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:

  1. Form a team to decide upon the scenarios to test, perhaps including:
    1. Supply TS with a valid study start date but without a TSVALNF column (following SEND 3.0 rules).
    2. Supply “NOT APPLICABLE” for the TSVALNF.
    3. 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.
    4. Supply a year-only date for the study start date with “DERIVED” in the TSVALNF.
    5. Supply a SEND 3.1-compliant typical TS file without the full SEND package.
    6. Use the correct dataset name in the ts.xpt file/use an incorrect dataset name within the ts.xpt file.
  2. Get a volunteer to create the eCTD.
  3. Get volunteers to create the datasets.
  4. Get a volunteer to submit the eCTD to the test gateway and share the results with the team.
  5. 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:
    1. Use the current Sample Data Submission path processing TRC Sample Submission.
    2. The submission should be in eCTD format.
    3. Application number: Use the real application number or the TRC Sample Submission from the PHUSE Nonclinical Topics Working Group.
    4. Test request and application type should be the TRC Sample Submission from the PHUSE Nonclinical Topics Working Group.
    5. Include the TRC Sample Submission from the PHUSE Nonclinical Topics Working Group in the cover letter.
  6. Wait for the FDA response.
  7. 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.
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