Good Clinical Practice (GCP) Practice Exam

The purpose of a Case Report Form (CRF) is to record protocol-required information for each trial subject. This structured document is essential in clinical trials as it collects data on all relevant variables that the study protocol dictates must be monitored. This includes information on demographics, medical history, treatment administration, adverse events, and outcome measures, which are crucial for analyzing the efficacy and safety of the intervention being tested.

CRFs ensure that data is collected consistently across all participants and sites, enabling researchers to compile and analyze the results systematically. The systematic approach to data collection through the CRF is vital for regulatory compliance and the integrity of the trial's findings, as it serves as an official record of the data collected during the study. This diligent record-keeping is a cornerstone of good clinical practice, ensuring that trials adhere to ethical standards and provide reliable data for scientific evaluation.