Nonclinical ts.xpt files that are typically created and submitted to the FDA.
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.
Paula Rowley (PHUSE Project Assistant)
CURRENT STATUS Q22021
|Project concluded, see final deliverables below.|
|Anthony Fata||Booz Allen Hamilton|
|Kishore Pothuri||Vita Data Sciences|
|Lalit Verma||Janssen Research & Development|
|Lou Ann Kramer||CDISC|
|Rick Thompson||Janssen Research & Development|
|Sonja Geuens||Janssen Research & Development|
|Objectives & Deliverables||Timelines|
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:
|A detailed timeline will follow shortly with a target end date of September 2021.|