Sponsor TMF Documents for CRO Oversight During an Ongoing SaMD trial

[Jaeyoung Choi]

Hello,

I work for a SaMD company, and we are currently conducting a confirmatory clinical trial through a CRO.

My understanding is that, even when clinical trial activities are delegated to a CRO, the Sponsor retains the ultimate responsibility for the trial.

Our Project Management Plan (PMP) specifies that the complete TMF maintained by the CRO will be transferred to the Sponsor at the end of the study. However, during the ongoing study, I am trying to determine which documents should be maintained in the Sponsor TMF to demonstrate appropriate oversight of the CRO.

Based on the TMF Reference Model, I am currently considering the following artifacts:

01.01.01 – Trial Master File Plan
01.01.02 – Trial Management Plan
01.01.03 – Quality Plan
01.01.07 – Communication Plan
01.01.08 – Monitoring Plan
01.01.12 – Trial Status Report
01.01.14 – Audit Certificate
01.01.16 – Risk Management Plan
01.01.17 – Vendor Management Plan
01.01.18 – Roles and Responsibility Matrix
01.01.20 – Operational Oversight
01.04.01 – Kick-off Meeting Material
01.05.01 – Relevant Communications
01.05.02 – Tracking Information

Third Party / CRO Management

09.01.01 – Qualification and Compliance
09.01.03 – Ongoing Third Party Oversight
09.02.02 – Vendor Selection
09.02.03 – Contractual Agreement
09.03.01 – Relevant Communications
09.03.02 – Tracking Information
09.03.03 – Meeting Material
09.03.04 – Filenote

Functional oversight, where applicable

05.04.03 – Monitoring Visit Report
05.04.05 – Additional Monitoring Activity
10.01.01 – Data Management Plan
10.03.11 – Database Lock and Unlock Approval
11.01.01 – Statistical Analysis Plan

Would this be an appropriate set of documents for the Sponsor to maintain during the study to demonstrate CRO oversight?

Are there any artifacts that you would add or remove, particularly where the complete CRO-maintained TMF will be transferred to the Sponsor at study completion?

Thank you in advance for your advice.

[Author]

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