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A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting.
The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.
Case reports should encompass the following five sections: an abstract, an introduction with a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, and a brief summary of the case and a conclusion.
Important part of the CRF is an informative header and footer, which can be customized. [7] In general, the header includes protocol ID, site code, subject ID, and patient initials. Whereas, the footer includes investigators signature, date of signature, version number, and page number.
A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant.
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2 CRFs. In Oracle Clinical and RDC Classic, the term CRF, which is an acronym for Case Report Form, refers to the form that is used by investigators to collect information and data about a patient in the clinical trial. This form can be either paper or electronic.
A case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports usually describe an unusual or novel occurrence and as such, remain one of the cornerstones of medical progress and provide many new ideas in medicine.
ing to ICH GCP EC 1.11, a case report form is a printed, optical, or electronic document designed to record all of the protocol required information to be reported on each trial subject. CRFs are designed by the sponsor or sponsor-investigator and maintained at the investigative site.

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