what is crf in clinical trials

A Case Report Form (CRF) is a specialized document used in clinical research to record the protocol and required information about each participant. It is the main tool that investigators use to collect information from clinical trial participants, and it enables efficient and complete data collection, processing, analysis, and reporting. The sponsor of the clinical trial develops the CRF to collect the specific data they need to test their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time snapshot of a patients physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. An effective CRF allows for components to be reused across the clinical trial, saving time and money. However, a poorly designed CRF is one that is missing requested data or has unnecessary information, meaning that it requires edits and modifications. To ensure the accuracy and completeness of the data entered in CRFs, monitors are usually hired by the sponsor to audit the CRF.