Regulatory & Documentation
Trial Master File (TMF)
The Trial Master File (TMF) is the collection of essential documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced, maintained by the sponsor and the investigator throughout and after the trial.
ICH E6(R3) and the DIA TMF Reference Model define the standard TMF structure (zones and artifacts). Modern eTMF systems (Veeva Vault, Wingspan, Phlexglobal) replace paper binders with structured, audit-ready electronic repositories.
TMF inspection-readiness requires real-time filing, completeness metrics, and version control; lagging or incomplete TMFs are among the most common Form FDA 483 findings.
Related terms
Good Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
Clinical Trial Monitoring
Clinical trial monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
Request a demo