Who should I contact if I have TMF related questions?
Please contact the DAIDS TMF Team at NIAIDDAIDSTMF@mail.nih.gov. This group email address includes all members of the DAIDS TMF Team.
Where can I find the key documentation for established TMFs (i.e., TMF Plan, Vendor Management Plan, TMF Index, etc.)?
Fundamental TMF documents can be found in the RSC Veeva Vault (VV) eTMF system and in the NIH Box under TMF Resources for a particular protocol.
What is the Naming and Filing Guidelines? What information can I expect from the Naming and Filing Guidelines?
The DAIDS TMF Naming and Filing Guidelines defines the metadata requirements, naming conventions, and filing classifications for TMF documents in the DAIDS RSC Veeva Vault (VV) eTMF system.
Where do I find the Naming and Filing Guidelines?
You can find the DAIDS TMF Naming and Filing Guidelines in the RSC Veeva Vault (VV) eTMF system.
Do I need a Submission Form every time I make any submission into Veeva Vault?
Yes, you will need to provide a complete Submission Form each time you submit/upload any document to the RSC Veeva Vault (VV) eTMF system for applicable studies. This helps the RSC TMF Team complete processing (filing and classifying) a document in the system. If a Submission Form is not provided at the time a document is submitted, the RSC TMF Team will generate a Document Request task to request upload of the missing Submission Form.
What is the DAIDS Electronic Systems Mapping Document? What information should I expect from Electronic Systems Mapping Document?
The DAIDS Electronic Systems Mapping (ESM) Document is a document that provides a list of electronic systems used during the course of a specific DAIDS-approved study to maintain TMF documents. The ESM document is protocol specific and confirms the validation status of each system, provides a list of document types stored within each system, confirms if a system has inspector access, and identifies each System’s Owner.
Note: This document applies to only those systems used to house TMF related documents generated during the course of a study.
Where do I find the DAIDS Electronic Systems Mapping Document?
The DAIDS Electronic Systems Mapping document can be found in the RSC Veeva Vault (VV) eTMF system and in the NIH Box under TMF Resources for a particular protocol.
Which e-mail communication should be filed?
The e-mail communications that should be filed are those generated throughout the conduct of a clinical study, particularly e-mail communications that enable:
- evaluation of the conduct of the study
- key decisions made during the study
- the integrity of the study data; and
- compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. All e-mail communications should be assessed for relevance on a case-by-case basis. Those determined to be relevant should be retained in the TMF.
If an e-mail is a sole source or evidence of the confirmation of an agreement or approval for processes or for decisions for a particular course of action (i.e., medical advisor approval of subject eligibility), the e-mail should be filed as an essential document in the TMF. An e-mail is relevant if it contains agreements or significant discussions and key decisions regarding:
- study administration and conduct
- protocol instructions, clarifications, and violations
- safety information and reporting
- awareness of issues arising during the study, especially exceptional or critical circumstances.
- study committees or boards and regulatory authorities; or
- processes or decisions made where there is no SOP or policy to support that process or decision.
It is important that both sent and received e-mails are filed in the TMF and that the filed e-mail includes the entire e-mail thread (where relevant).
What is your recommendation regarding the use of zip files to upload multiple e-mails relevant to the same subject or related correspondence?
Zip files should not be uploaded. Per the Guidance for DAIDS Trial Master Files, each document should be uploaded as a separate artifact.
Should you save each individual e-mail within an e-mail thread? Or should you save the entire thread once the subject matter is closed?
This is up to you. You may save the entire thread once you have determined the subject matter is closed. However,
- knowing which is the “final” e-mail can be difficult; and
- dependent on e-mail branching or changes to the subject matter, it can also be difficult to ensure that ALL the messages in the thread are included in the “final” e-mail.