The Trial Master File (TMF) is a collective term for all the essential clinical trial documents required for the evaluation of a clinical trial. Typically for many Start-Up companies, the TMF is held by and managed by the company’s CRO. Most TMFs are now electronic thus facilitating easier access, review and compilation.

In planning for a filing, it is critical that sponsors assess the TMF prior to completion, sign off and hand off from the vendor. It is during this assessment that gaps in document files, errors, missing documents etc. are identified and remediated. The TMF assessment is essentially an assessment of quality in the TMF, the purpose of which is to identify gaps in the TMF and enable gaps to be addressed prior to sign off as once the TMF is finalized and transferred back to the sponsor, it is more difficult to ‘fix’ any issues identified.

DArcy Compliance Consulting has conducted many TMF assessments for clients. We advocate conducting TMF assessments as early as possible so that gaps identified can be addressed, and processes for TMF review can be implemented to reduce errors.