An Overview of TMF Oversight—Part 2: The Vendor Oversight Checklist
In part 1 of our vendor oversight series we talked about managing trial master file (TMF) vendors. In practice, this is just one of the many variations of risk management across a clinical trial. In that post we discussed the “Why?” This time we want to give you a tool to incorporate the “How?” Whether you want to formally establish your internal process or use this as a guide to mutually set expectations with a vendor, we hope you keep this list (or one like it) close by as you are assembling your external partnerships so you can have some peace of mind.
Vendors are part of separate organizations with their own approaches, expectations, processes, and other unique attributes. They should have their own process to align with sponsors. However, sponsors must have their own “checklist” for controlling risks (and, of course, costs) and ensuring adherence to GCP standards.
The risks fall squarely on the sponsor since they are the ones responding to regulatory scrutiny. Addressing these risks means having a solid and validated process in place. We have assembled a checklist with five primary categories to help sponsors keep some essential considerations in mind when collaborating with TMF vendors (as well as other vendors for assisting in the conduct of a clinical trial):
- Initial Vendor Assessment
- Scope of Work
- Project Plans
- Performance Reviews
- TMF Review
Whether you are new to vendor management or a seasoned pro, we all need a set of fundamentals as a foundation. While this checklist does not nearly cover all considerations, it serves as a healthy “gut check” for your vendor collaboration relationships. We hope you find this foundational guide productive for your current and future collaborations.