Who should I contact if I have any TMF related questions?
Please contact DAIDS TMF Team at NIAIDDAIDSTMF@mail.nih.gov.
Where can I find the fundamental documents for established eTMFs (i.e., TMF Plan, Electronic Systems Mapping Document, TMF Index, etc.)?
You can download a copy of the TMF Fundamental Documents by visiting the DAIDS TMF Resources SharePoint Site - Website on the RSC Website in the Trial Master File Resources page. (Note: access to the SharePoint site requires login).
You can also visit the TMF Fundamental Documents Tracker - Excel on the RSC Website to view high level TMF information (e.g. study status, version and date of TMF fundamental documents, planned TMF archival etc.).
What are the Naming and Filing Guidelines and how am I supposed to use them?
The Naming and Filing Guidelines contain information on how to properly name a document. This guide must be used and followed when filing DAIDS TMF documents. The Naming and Filing Guidelines defines the metadata requirements, naming conventions, and filing classifications for TMF documents that will help ensure consistency in filing and promote easy retrieval of documents during an inspection.
Where do I find the Naming and Filing Guidelines?
You can find the naming and filing guidelines on the RSC Website Trial Master File Resources Page.
What is the DAIDS Electronic Systems Mapping Document (ESM)? What information should I expect from the ESM?
The DAIDS ESM is a document that provides a list of electronic systems used during the course of a study to maintain TMF documents. The ESM document is protocol specific and applies to only those systems used to house TMF related documents generated during the course of a study.
Where can I find guidance on what constitutes relevant communication and email communication (i.e., what needs to be filed in the TMF)?
The DAIDS TMF team has created a PowerPoint presentation entitled, ‘Relevant Communications Presentation’, located on the RSC Website, which provides guidance on this topic.
Are there plans to link the Quality Management system (QMS) with the TMF?
No; at this time DAIDS does not have the ability to link the DAIDS QMS with any electronic system that makes up a DAIDS TMF.
Why can I not create my own username and password, or use my PIV Card for the RSC Veeva Vault or other approved electronic system?
A Single-Sign On (SSO) method to log in with your PIV card is not available for all approved electronic systems that make up DAIDS TMFs. Each electronic system owner has configured access requirements based on their own SOPs which are not linked to the DAIDS SSO method.
Is NIH Box still used for official TMF documents?
TMF Tools and Resources are exclusively available on the RSC website. NIH Box will be phased out by the end of 2024.