What is a "case report form" (CRF)?

A case report form (CRF) is a critical tool used in clinical trials to systematically collect data from each participant. It serves as a standardized document that captures all necessary information related to the trial, including demographic data, clinical history, and specific outcomes relevant to the study's objectives. The use of a CRF ensures consistency and accuracy in the data collection process, which is essential for the integrity of the research.

The CRF is designed to align with the protocol of the study, ensuring that all relevant information is gathered uniformly across all participants. This systematic approach is vital for data analysis and regulatory compliance, as it helps maintain the quality and reliability of the clinical trial results. By focusing on directly collecting individual subject data, the CRF plays a crucial role in the overall data management plan of a clinical research study.