Full course description
The case report form (CRF) is a paper or electronic document or series of documents designed to record all of the protocol-required information and results for each clinical trial participant. Accurate and timely entry of data into the CRF is important for the sponsor to ensure proper conduct of the trial, and for the assessment of safety and efficacy endpoints. The data collected on the CRF is the groundwork for any trial related reports or publications and therefore study teams must follow International Council on Harmonization (ICH) GCP guidelines for CRF completion. The purpose of this SOP is to establish standards for the accurate and timely entry of data into the CRF for clinical trials. These standards should be followed unless there are more specific requirements detailed in the study contract or clinical trial agreement (CTA).