Trial master file (TMF)
In Documents & records
The trial master file is the complete collection of essential documents that allows the conduct of a trial and the quality of its data to be evaluated. The sponsor holds the sponsor TMF; the site holds its own equivalent, the investigator site file. Inspectors read the TMF to reconstruct what happened and when.
Why it matters
"If it isn't documented, it didn't happen" is the working rule. An otherwise well-run trial can fail an inspection on an incomplete TMF.
Example
An inspector asks to see the ethics approval that was in force on the day the first participant consented. The TMF has to produce that exact version, with its date.
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