Trial master file (TMF)
A TMF is a collection of essential documents used by sponsors, CROs and investigator sites to manage the clinical performance study, as well as by monitors, auditors, and inspectors. The legislation does not distinguish between paper TMFs and electronic TMFs. However, track change of any action in the electronic TMFs (data entry, data edit, system access, decision, and study activity trails) must be guaranteed via audit trails. The eTMF systems must be validated to demonstrate that the functionality is fit for purpose, with formal procedures in place to manage this process.
