Are ESOs required to deliver quarterly eTMF Reports to the DAIDS TMF Team under the updated DAIDS TMF processes?
Effective February 1, 2024, ESOs do not need to send quarterly reports. The DAIDS TMF Team will meet with system owners to discuss and review reports generated by system owners biannually.
Deliverables and expectations for this meeting are outlined in the TMF System Oversight Metrics and Summary Analysis Requirements - PDF, posted publicly on the RSC Website under TMF Resources.
How will ESOs know which DAIDS staff require access to their system for a TMF?
Starting with IMPAACT 2040, the DAIDS TMF Team will provide all ESOs with a list of DAIDS staff that require access to DAIDS TMF documents in their systems within 30 days of the TMF initiation.
What is the time period for the completeness reports?
A completeness report is required for the entire life of the TMF. This report can be generated a month before this biannual meeting.
Which studies should be included in the timeliness and quality oversight reports?
The DAIDS TMF Team will indicate which study reports are required prior to the Biannual meeting. Timeliness and access reports must cover all documents for DAIDS studies where you are the electronic system owner.
What is the time period for the timeliness and quality oversight reports?
For information on ESO reporting requirements, refer to the DAIDS TMF System Oversight Metrics and Summary Analysis Requirements – PDF.