Trial Master File
The collection of essential documents that demonstrates the conduct of a clinical trial complies with GCP and applicable regulatory requirements.
Definition
The Trial Master File (TMF) is the structured collection of essential documents, protocol, investigator brochure, regulatory approvals, informed consent forms, monitoring reports, IRB/EC correspondence, drug/device accountability, deviation logs, audit reports, that allows an inspector to reconstruct the conduct of the trial and assess GCP compliance. ICH E6(R3) defines the essential-documents list. Most modern trials use an electronic TMF (eTMF) aligned to the DIA TMF Reference Model.What this means in practice
TMF inspection-readiness is a perennial weak spot in BIMO inspections. Regulators expect the TMF to be contemporaneous, complete, and reconstructable in real time, not assembled retroactively before an inspection.- •Treating TMF assembly as a closeout activity rather than a continuous trial-conduct discipline.
- •Relying on an eTMF system without governance, system features alone do not produce inspection readiness.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsData integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
Structured paper or electronic forms used to capture protocol-required data for each enrolled subject.
International standard for the design, conduct, and reporting of clinical trials.
Voluntary, informed agreement to participate in research after disclosure of risks and benefits.
More in Clinical & Trials
· Same categoryTrial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Any untoward medical occurrence in a subject, whether or not related to the device.
An IVD's ability to detect small quantities of an analyte.
Trial design that uses Bayesian statistics, often incorporating prior data from related studies or registries.
Primary references
3 sources- 1
DIA TMF Reference ModelVerifiedDIAtmfrefmodel.com
- 2
ICH E6(R3) GCPVerifiedICHich.org
- 3
ClinicalTrials.govVerifiedNIHclinicaltrials.gov
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