Case Report Form (CRF)
The structured form used to capture protocol-required information for each trial subject.
What it means
CRFs (usually eCRFs) collect protocol-specified data per subject. Field labels, prompts, and translated instructional text must match protocol terminology exactly, and any translated free-text collected from patients must be back-mapped to controlled terminology.
Why it matters for LATAM submissions
CRF label drift from protocol terminology creates monitoring queries and eventually data cleaning rework at database lock.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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