Trial master file (TMF)
What is a trial master file (TMF)?
A trial master file, or TMF, is a collection of documents that show the clinical trial is being conducted according to regulatory requirements, such as Good Clinical Practice.
The TMF must be continually maintained and updated throughout the trial to include any documents prepared before, during, or after the trial’s completion. The TMF can be paper, electronic (eTMF), or a hybrid of both types. No matter which format, it should be available upon request, and each clinical trial must have its own TMF.
The TMF is comprised of an Investigator TMF (held by the investigator/institution) and the Sponsor TMF (in possession of the sponsor company). Each role (e.g., institution, investigator, sponsor) is responsible for collecting specific documents, and if a contract research organization (CRO) is hired to handle outsourced duties, they may be responsible for some of the documents in the TMF.
What is included in a trial master file (TMF)?
Trial master files are collections of all the documents that show a clinical trial meets regulatory requirements and are thus a necessity for all clinical trials.
Some of the documents that may be included in a TMF include:
- A completed investigational medicinal product (IMP)
- Completed forms and reports collected from the trial activities
- Validation documents showing proof of trial-specific software and computer systems (e.g., interactive response technologies (IRT), case report form (eCRF))
- Statistical analysis software program validation
- Sample size estimation
- Documentation from Good Manufacturing Practice (GMP) processes
- A data management and validation plan