How do I perform TMF oversight of the RSC Veeva Vault?
Details on how to perform oversight activity can be found in the DAIDS QMS Work Instruction DAIDS-OPC-A15-WI-00002 DAIDS Primary Contact (PC) Oversight of TMF Documents. Additional training related to this topic is covered in the TMF Oversight: DAIDS PC Training and Demonstration; posted to DAIDS Connect.
How do I perform TMF oversight of other approved electronic systems?
Details on how to perform oversight activity can be found in the DAIDS QMS Work Instruction DAIDS-OPC-A15-WI-00002 DAIDS Primary Contact (PC) Oversight of TMF Documents. Additional training related to this topic is covered in the TMF Oversight: DAIDS PC Training and Demonstration; posted to DAIDS Connect.
Do I need to create a DAIDS PC Memo every time I perform oversight activity?
As of February 1, 2024, the DAIDS PC memo is now called the DAIDS Oversight Memo, and it is an optional document. Additional details can be found in the DAIDS QMS Work Instruction DAIDS-OPC-A15-WI-00002 DAIDS Primary Contact (PC) Oversight of TMF Documents.
Do I need to create a DAIDS PC Oversight Checklist every time I perform oversight activity?
Yes, you will need to create the DAIDS PC Oversight Checklist every time you perform TMF oversight. Additional details can be found in the DAIDS QMS Work Instruction DAIDS-OPC-A15-WI-00002 DAIDS Primary Contact (PC) Oversight of TMF Documents. Additional training related to this topic is covered in the TMF Oversight: DAIDS PC Training and Demonstration; posted to DAIDS Connect.
Do I need to create a DAIDS PC Delegation Memo every time I perform oversight activity?
The DAIDS PC Delegation Memo is only required when you need to document transfer of all or certain specific DAIDS PC oversight responsibilities. The memo is created one time, filed to all TMFs, and it should be shared with the DAIDS TMF Team.
Additional details can be found in the DAIDS QMS Work Instruction DAIDS-OPC-A15-WI-00002 DAIDS Primary Contact (PC) Oversight of TMF Documents. Additional training related to this topic is covered in the TMF Oversight: DAIDS PC Training and Demonstration; posted to DAIDS Connect.
Where do I file the DAIDS Oversight Memo, DAIDS PC Oversight Checklist, and DAIDS PC Delegation Memo?
The location to file oversight documentation is based on the protocol-specific Index for the TMF. A summary outlining where to file your PC Memo, Delegation Memo, and Checklist are below.
HPTN 083, HPTN 084, IMPAACT 2017: RSC VV in Zone 09, Third Parties > General > Relevant Communication
MTN-034, MTN-042, MTN-043, IMPAACT 2019, IMPAACT 2032, HPTN 083-01, HPTN 084-01, PHOENIx, A5359, IMPAACT 2023, IMPAACT 2034, A5418, IMPAACT 2036, IMPAACT 2040: RSC VV in Zone 09, Third Parties > Third Party Oversight > Ongoing Third Party Oversight
How will I know that the documents have been uploaded into the DAIDS approved electronic system?
DAIDS PCs should work with ESOs to set up a process notifying the DAIDS PC when documents have been uploaded to an electronic system. Examples include but are not limited to auto notifications that can be activated, which will send you a notification of any upload or any assigned task. If auto notifications are not available, reports can be requested from the vendors on a regular basis which will help DAIDS PCs understand the status of document uploads.
How will I know what new documents have been uploaded since the last DAIDS PC checklist was completed and is there a possibility to ask the vendors for a report of documents uploaded?
This will depend on the electronic system in which you are completing your review. Some electronic systems are configured to allow you to sort / filter by the document date, which can help you limit your review to documents to a specific time frame. Not all electronic systems that make up our Sponsor TMF have this capability.
Do I need to complete PC review for documentation in the Index that has DAIDS staff listed as DAIDS PCs, however, the Source Location is listed as Clinical Research Site (CRS)?
Effective February 1, 2024, DAIDS PC review will not be applicable for documents residing at the CRS. The updated DAIDS-OPC-A15-WI-00002- DAIDS PC Oversight Version 3.0 addresses DAIDS PC review of artifacts where the Source location in the DAIDS TMF Index is the CRS.
Does the DAIDS TMF team monitor gaps in the DAIDS TMF and send follow up questions to DAIDS staff?
Starting on February 1, 2024, the DAIDS TMF Team will be performing spot checks and access checks for all electronic systems.
Why is a DAIDS PC Checklist still required if the PC review is not required when someone is the DAIDS PC and Authoritative Source?
In order to document a centralized process for sponsor oversight, a PC checklist must be filed whether this checklist captures a review or confirms that the DAIDS PC was the Authoritative Source. This documentation allows auditors/inspectors to see evidence of oversight that aligns with the risk assessment for TMFs (e.g., Critical risk ranked artifacts require 100% review).
In searching for my document, I see that my document was correctly filed in the data management folder, however I cannot determine the zone number.
Some systems do not include the Zone / artifact number in their navigation tree. The Zone names align with our Indexes and the TMF Reference Model, and the Zone number can be looked up in the Index when needed (e.g., the Data Management Zone is number 10.)
Even if documents are housed in another system, are the requirements for the DAIDS PC memos and checklist still applicable?
Memos and checklists are required for documents across all electronic systems of all DAIDS decentralized TMFs.
All my DAIDS PC oversight responsibilities were delegated and documented in a PC Delegation Memo. Do I need access to the TMF?
If a DAIDS PC has delegated all oversight work and will not be looking at documents within an electronic system, then it is not required for that DAIDS PC to maintain access to the electronic system; only the delegate would need to maintain access.
When multiple DAIDS PCs are listed as responsible for PC oversight, who is responsible for checking each document?
Each DAIDS PC in every Team, Program, and Division has a shared responsibility to complete PC oversight of artifacts where they are listed in the index as a DAIDS PC. A mechanism should be established within your team to ensure that PC Oversight work is accomplished in a way that works for your team.
There has been a change to the DAIDS PC roles within my team. How do the access permissions and the TMF Plan get updated?
Contact the DAIDS TMF Team as soon as you learn of a DAIDS PC role change. The DAIDS TMF Team will ensure that the change in DAIDS PC is reflected in the TMF Plan for a study during the next revision.
How do I perform DAIDS PC oversight in electronic systems that I do not have access to, such as Protocol Deviation Reports Utility, SDMC Veeva Vault, Medidata Rave, and CBAR?
The DAIDS TMF Team will issue guidance to DAIDS PCs once a process for oversight in these systems is established. This is expected by the summer of 2024.
What happens if I have a DAIDS PC Oversight Memo already in the TMF that may not be consistent with the new approach? How do you 'remove' or 'deactivate' a submitted TMF memo?
You do not have to remove or deactivate anything that was already in a TMF. This documentation will allow an inspector or auditor to see that DAIDS was in compliance with the SOPs and work instructions that existed during that time period prior to the new procedures going into effect.
If a current memo references an older memo (the older memo pre-dates the initiation of a particular TMF), do we need to upload both memos, or just the current version that applies to the current TMF?
As a general rule, documents should not be filed in the TMF based on the TMF initiation date but rather the study start date. For example, if a study started in 2019, DAIDS may not have initiated a TMF until 2021/2022. Any memos that were issued in 2019 until today should be filed in the TMF. Also, if Version 1 was issued in 2019, Version 2 in 2021 and Version 3 in 2023 and the study was ongoing during that time (2019- present) all 3 versions of a document should be in the TMF.
If there are 5 artifacts that are risk ranked 'Critical' that require DAIDS PC review, do I only need to pick one document from each of the five artifacts, even if there are multiple sub-artifacts for each 'Critical' artifact?
Only one document from each artifact must reviewed as part of the annual DAIDS PC review. Since the risk assessment is defined at the artifact level and not at the document level, any sub-artifact(s) from the artifact can be reviewed to meet the DAIDS PC requirements. It is up to the DAIDS PC to determine what document you review.
What does the artifact number in the DAIDS PC checklist correspond to in an electronic system?
Depending on the electronic system configuration, the names of the TMF folders will have either an artifact number or an artifact name. Either of these names can be used to identify the document in the checklist.
If there are the same exact documents for two studies (e.g., HPTN 083 & HPTN 084 may have the same Medical Officer CVs). Do they need to be reviewed twice for the PC Checklist per study?
Each protocol/TMF is treated separately, and documentation of oversight is based on protocol/TMF. If the documents are the same, the PC would still need to QC the document(s) in each TMF to ensure they are correctly filed in each TMF and then that Oversight documentation is filed in each TMF. DAIDS PCs could prepare one PC Checklist that lists both protocols, but the DAIDS PC would need to make sure the PC Checklist was associated with both TMFs when submitted to the RSC Veeva Vault.
Is it possible to add a URL in the TMF Index to direct the DAIDS PC to an artifact’s exact system location in the TMF?
The TMF Index cannot have hyperlinks added to send staff to each electronic system. The DAIDS TMF Electronic System Contact Listing - PDF, posted on the RSC Website, contains the direct access links to each approved electronic system.