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A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
The ICH guidelines on good clinical practice (GCP) use the term ‘case report form’ (CRF) to refer to these systems. No matter what CRF is utilized, the quality and integrity of the data is of primary importance.
The case report form (CRF) is the data collection tool for the clinical trial and can be paper or electronic. Paper CRFs will be printed, often using No Carbon Required paper, and shipped to the investigative sites conducting the clinical trial for completion after which they are couriered back to Data Management.
The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for clinical data management can be self-contained or part of the functionality of a CTMS.
The purpose of the case report form (CRF) is to collect relevant data in accordance with the protocol and in compliance with regulatory requirements. The CRC collects the data on the CRF and submit to the sponsor either electronically or paper format.
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Many of these providers offer specialized solutions targeting certain customer profiles or study phases. Modern features of EDC now include features like cloud data storage, role-based permissions, and case report form designers, [1] as well as clinical trials analytics, interactive dashboards, and electronic medical record integration.