What is Quality Control and what does it look like for your clinical trial? Those are some of the questions you may have about TMF Quality that are addressed by The Trial Master File Reference Model Quality Group’s (TMF RM QG) latest output documents. They have recently released their expert recommendations for a thorough and complete TMF review. The group, with representation from across the world, released straightforward guidelines to improve your TMF quality.
The review of the TMF is two-part process that consists of quality control of both the individual TMF documents as well as the entire TMF. The group recommends ensuring each document meets the criteria of the mnemonic “R.U.T.O.L.A.” to be considered “TMF Ready.” The RUTOLA criteria will definitely get you out of the rut of the old guessing game when it comes to QC of TMF documents! Each document should be:
- Retrievable – A document that gets filed should be quickly and efficiently accessible utilizing appropriate metadata and an organized filing system, such as the TMF Reference Model.
- Unique – Each required document is present without duplicates.
- Translations – All required translation documentation is present.
- Original – Documents are unaltered.
- Legible – All document information is comprehensible and clean with identifiable stamps and signatures
- Applicable – The document is necessary to support the story of a clinical trial and is required as per the filing system (TMF Reference Model) or the company’s policy.
TMF Quality Tools
Almost every undertaking requires the right tools and ensuring TMF quality is no different. The TMF RM QG also outlines some essential tools to pave your way to TMF quality success. These tools include TMF Reference Model (ideally customised to fit the needs of the specific study), a comprehensive TMF Management Plan, and a Corrective Action Plan.
This is a small extract of the work that the TMF RM QG have published. You can download the full document, as well as a PowerPoint presentation slide deck that was presented to the TMF Reference Model group in November 2016 from our Resources web page.