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Case Report Form (CRF) A printed, optical or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial
Case report forms (CRFs) are critical documents in clinical research that record study data for each participant. Careful design of CRFs is crucial for capturing complete, accurate, reliable data that can withstand scientific and regulatory scrutiny.
1 Οκτ 2014 · Case report forms (CRFs) are used to collect data in clinical research. Case report form development represents a significant part of the clinical trial process and can affect study success.
Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data.
To describe the procedure for development and design of Case Report Forms. 4. Scope This SOP describes the procedure for development and design of Case Report Forms (CRFs) used in clinical trials sponsored by NNUH. ICH GCP E6/SI 2004/1031 DocuSign Envelope ID: 900E6F35-29F7-4979-8CE6-6241173CA302
The purpose of this SOP is to describe the procedure to be followed when designing, using and completing paper Case Report Forms (CRFs) or electronic CRFs (eCRFs) for a research study that is being sponsored or co-sponsored by the Trust. CRF captures all the necessary data for each participant during a research study.
5.1.1 Case Report Forms (CRFs) are the usual data collection tool used in a clinical trial and are essential for quality assurance and control. The CRFs can be either in paper format (pCRF) or an electronic CRF (eCRF). The procedures outlined below apply to both CRF formats.
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