Case Report Form
A structured document used in clinical trials to record data for each participant according to the study protocol, serving as the primary data-collection instrument.
Full Definition
A Case Report Form (CRF) is the official document—paper-based or electronic—through which study investigators record all protocol-required clinical observations, measurements, and participant responses for each enrolled subject. In dental clinical trials, CRFs may capture variables such as pocket depths, radiographic measurements, adverse events, and patient-reported outcomes. Editors working on trial manuscripts should confirm that the CRF design is referenced in the methods section and that collected variables align with the stated outcomes. Electronic CRFs (eCRFs) are increasingly standard in multicentre dental studies. The CRF is a regulatory document and its integrity directly underpins the validity of reported findings, making accuracy in its editorial representation critical.
Usage
Usage note: CRF should be expanded on first use. Distinguish from 'case report', which is a manuscript type, not a data-collection instrument.
In Context
- "All clinical measurements were recorded on a standardised Case Report Form that had been piloted in a feasibility study." — Methods section of a multicentre dental RCT
- "Discrepancies between the Case Report Form and the source data were resolved by the trial monitor prior to database lock." — Data management section of a clinical trial report