Effective April 1, 2024, per DAIDS’ decision, a TMF Submission Form will not be required for TMF documents uploaded to the DAIDS RSC Veeva Vault (VV) eTMF system for any study.
Please note that a TMF Submission Form will be required for TMF documents uploaded to the DAIDS RSC VV eTMF system through March 31, 2024, for studies: IMPAACT 2017, IMPAACT 2019, IMPAACT 2032, IMPAACT 2023, IMPAACT 2034, HPTN 083, HPTN 084, HPTN 083-01, HPTN 084-01, MTN-034, MTN-042, MTN-043, A5300B, and A5359. DAIDS RSC VV eTMF system tasks related to Submission Forms received through March 31, 2024, should be addressed by task owners. The DAIDS RSC will notify task owners and the DAIDS TMF Team by April 15, 2024, of any open tasks related to TMF Submission Forms.
Any TMF Submission Form uploaded to the DAIDS RSC VV eTMF system on or after April 1, 2024, will be immediately withdrawn (except in response to an open task, as noted above). No document review will be completed, including review or updates to document classification, naming convention, study/country/site affiliation, metadata information, or document quality.
The DAIDS RSC is coordinating with the DAIDS TMF Team to update TMF documentation and resources to reflect DAIDS’ decision.