How do I know under which zone, artifact, and sub artifact I should upload a specific document in the TMF?
The DAIDS TMF Index has information on the DAIDS-specific sub-artifacts/document location as well as the definition/purpose for each artifact. If there is a specific document generated for a study that is not listed in the TMF Index, the Authoritative Source and/or DAIDS PCs should note this in their reviews of Network TMF Index Templates and protocol specific TMF Index documents, so that the DAIDS TMF Team can ensure the feedback is incorporated in the Index before finalization.
If I have two versions of document(s) to be uploaded, do I submit them both to a DAIDS TMF?
If you have a new version of a document in addition to the original, yes, both versions must be uploaded independently. Both documents would appear as individual documents in the TMF.
I have one document that belongs to multiple protocols. Do I have to submit this one document multiple times for all protocols?
No, you don’t need to submit that one document multiple times for multiple protocols. However, you will need to specify in the metadata which protocols the document is associated with. Please contact the DAIDS TMF Team (NIAIDDAIDSTMF@mail.nih.gov) if you have a question about associating a specific document to a protocol within an approved electronic system.
How do I file a Note to File (NTF) to explain an issue with a document in a system that I am not an Authoritative Source for?
Please contact the DAIDS TMF Team for assistance. The DAIDS TMF Team will coordinate with the ESO to get the appropriate documentation filed in the TMF in accordance with the DAIDS protocol specific TMF index.
When will I be expected to halt the submission/uploading of study-specific TMF documents.
As documents are generated, the documents applicable to a study should be filed into a TMF. This is an ongoing process over the course of the study. The DAIDS TMF Team will send a notification to all Authoritative Sources and DAIDS PCs 90 days before a TMF is locked to allow people time to upload any final documents to a TMF. At the end of that 90-day timeline, no further documents can be submitted to a TMF. If any additional documents that are generated after the TMF lock date, the Authoritative Source must contact the DAIDS TMF Team to inquire about steps needed to submit a document to a locked TMF.