Glossary Term
Case Report Form (CRF)
Definition
A Case Report Form (CRF) is a standardized document used in clinical trials to collect and record data for each trial participant. CRFs capture essential information, such as demographics, medical history, adverse events, and treatment outcomes, ensuring consistency and accuracy in data collection for regulatory submission and analysis.
Relevance to the MedTech Industry
CRFs are critical for ensuring the integrity of clinical trial data, which is essential for evaluating the safety and efficacy of medical devices. They provide a structured framework for data collection, enabling compliance with Good Clinical Practice (GCP) guidelines and supporting regulatory submissions to bodies like the FDA or EMA.
Additional Information & Related Terms
Good Clinical Practice (GCP) Governs the ethical and scientific quality of clinical trials, including CRF usage.
Adverse Event Reporting CRFs capture details of adverse events during clinical trials.
Electronic Data Capture (EDC) A system used for managing eCRFs in clinical trials.
Clinical Evaluation Report (CER) Summarizes data collected via CRFs for regulatory submissions.