DAIDS electronic Trial Master File (eTMF) Resources

DAIDS TMF Resources SharePoint

DAIDS TMF Resources SharePoint Site
Note access to the SharePoint site requires login.

TMF Fundamental Documents

TMF Fundamental Documents Tracker
Version 2.0 - February 2024

NIAID Policy Related Documents

DAIDS TMF Index Guiding Principles
Version 1.0 - July 2022

Guidance for DAIDS eTMFs
Version 6.0 - May 2023

DAIDS TMF System Oversight Metrics and Summary Analysis Requirements
Version 1.0 - November 2023

Primary Contact (PC) Review Checklist

Job Aid: Filling Out a PC Checklist
Version 1.0 - March 2023

TMF Oversight - DAIDS PC Checklist
Version 1.0 - December 2023
For an accessible version of the checklist please click the following TMF Oversight-DAIDS PC Checklist_Accessible.

RSC Veeva Vault (VV)

Guidance for DAIDS eTMFs for HPTN 083 & HPTN 084
Version 4.0 – July 2022

DAIDS RSC VV eTMF System User Guide
Version 1.0 – August 2020

DAIDS RSC VV eTMF System Quick Reference Card
Version 1.0 – August 2020

Note: If you are not already logged in to the DAIDS RSC Veeva Vault eTMF system, these links will take you to the Veeva Vault log in screen. Once you log in with your RSC Veeva Vault user name and password, you will be routed to the document.

Plans and Forms

RSC VV eTMF Submission Form
Version 3.1 - June 2022

Relevant Communications and Vendor Oversight Communication
Version 1.0 - December 2021

Name File Guide
Version 4.0 - February 2024

Job Aid: Filling Out a DAIDS TMF Submission form
Version 1.0 - March 2023

DAIDS TMF PC Oversight Delegation Memo Template
November 2023

DAIDS TMF Electronic System Contact Listing
Version 1.0 - December 2023

Training Resources

DAIDS TMF Index Recording 
May 2023

Remote video URL

 

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