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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 (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number.
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.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. 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.
This template is intended for external links. It is not designed for use as a citation template for reliable sources. It should be used in conformance with the external links guideline and with the relevant section of the Manual of Style. Do not use this template to advertise clinical trials to patients.
PHOTO: The seal of the U.S. Justice Department is seen on the podium in the Department's headquarters briefing room before a news conference with the Attorney General in Washington, Jan. 24, 2023.
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