CRF
Also written as: CRF — Case Report Form
A standardized document used to collect clinical trial data for each study participant in a systematic and organized manner.
Full Definition
Case Report Forms serve as the primary data collection instrument in cardiovascular clinical trials, capturing all protocol-specified information for regulatory submission and scientific analysis. Modern CRFs are typically electronic (eCRF) systems that include built-in edit checks, query management, and audit trails to ensure data quality and regulatory compliance. CRFs must capture all variables needed for primary and secondary analyses, safety assessments, and regulatory requirements. Design considerations include user-friendliness, logical flow, and minimal redundancy while maintaining comprehensive data capture. Source data verification compares CRF entries against original medical records to ensure accuracy and completeness.
Usage
Usage note: Distinguish from source documents; specify electronic (eCRF) versus paper-based when relevant.
In Context
- "All adverse events were recorded in the electronic CRF within 24 hours of occurrence." — Data management procedures
- "CRF completion rates exceeded 98% across all study visits and assessments." — Data quality report