Trial Master File
This SOP covers the creation, maintenance, and archiving of Trial Master File (TMF) and Investigator Site Files (ISFs).
Trial Master File
The UK Clinical Trials Regulations require that a Trial Master File (TMF) is maintained for every clinical trial and must contain essential documents demonstrating compliance with the protocol, Good Clinical Practice and the UK Clinical Trial Regulations.
Maintaining a well-organised TMF supports the smooth running of the trial and ensures readiness for audit or inspection.
Responsibilities
- Sponsor – has overall responsibility for ensuring a TMF is established and maintained.
- Chief Investigator (CI) / Principal Investigator (PI) – accountable to the sponsor for TMF/ISF compliance and oversight; may delegate tasks but not responsibility.
- Trial staff – may carry out TMF/ISF tasks if delegated and recorded on the delegation log, under CI/PI oversight.
This SOP applies to all clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP) organisations.