Trial Master File (TMF)

About the DAIDS Trial Master File Team

The DAIDS Trial Master File (TMF) Team is a team within the DAIDS Office for Policy in Clinical Research Operations (OPCRO) Office of the Director (OD) responsible for ensuring the overall health of DAIDS TMFs, establishing protocol specific TMF management documents, and collaborating with DAIDS staff and vendors to ensure DAIDS TMF compliance. 

The DAIDS RSC TMF Team establishes and maintains the RSC Veeva Vault eTMF System for applicable DAIDS TMFs, and processes and tracks TMF documents as required per protocol specific DAIDS TMF Indices. The DAIDS RSC TMF Team works closely with the DAIDS TMF Team to ensure that all documents needed to fulfill the study Sponsor’s regulatory obligations relating to TMF as per the TMF Index are processed within the specified timeline set by the Sponsor. The DAIDS RSC TMF Team manages TMF requests and correspondence from DAIDS and applicable vendors and plans and conducts trainings on TMF procedures and related issues.

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