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The Case Report Form (CRF) is an essential instrument used in the process of Clinical Trials. The requisite data from all the patients are captured in the form.

A Case Report Form is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.

The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time 'snapshot' of a patient's physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months.

The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs.

Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified by removing the patient's name, medical record number, etc., and giving the patient a unique study number. The supervising Institutional Review Board oversees the release of any personally identifiable data to the sponsor.

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