What is a Case Report Form (CRF) used for in clinical trials?

A Case Report Form (CRF) is an essential document used in clinical trials primarily for collecting patient clinical trial data. It serves as the data collection tool that captures all relevant information about each participant during the study, including demographics, medical history, clinical assessments, treatment administration, and outcomes.

The design of the CRF is critical as it determines how information will be recorded, ensuring that data is collected in a standardized and consistent manner across all participants and sites involved in the trial. This data is then used for further analysis to evaluate the efficacy and safety of the treatment being tested.

While other options may pertain to different aspects of clinical trials, such as study protocol approval, statistical analysis, or treatment ratios, they do not accurately describe the primary function of the CRF. The CRF focuses specifically on the systematic collection of participant data, which is foundational for the integrity and success of the clinical trial.