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Case Report Form (CRF)
The CRF is a record of all protocol required information regarding each trial participant that is to be reported to the sponsor. It can be in the form of a printed, optical, or electronic document. The use of electronic case report forms (eCRFs) has shown potential for increased efficiency, improved data quality, and high security.
The CRF allows for standardized data collection to improve efficiency and allow for exchange of data between investigation sites, investigators, and the sponsor. The document may include any demographic information, medical and social history, inclusion/exclusion criteria, physical exams, visit checklists, and adverse effects.
The investigator is responsible for ensuring a legible and accurate CRF that is completed in a timely manner, although data may be recorded by other research staff members such as the Clinical Research Coordinator (CRC).
The data on the CRF that is obtained from source documents must be consistent with those documents, or discrepancies should be explained. If changes are made to the CRF, they must be dated, initialed, and explained without obscuring the original entry.
Source: ICH GCP. (2020, June 10). Essential documents for the conduct of a clinical trial. Good Clinical Practice Network. Retrieved January 7, 2022, from https://ichgcp.net/8-essential-documents-for-the-conduct-of-a-clinical-trial