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Glossary Terms

Case Report Form

1. A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject. 2. A record of clinical study observations and other information that a study protocol designates must be completed for each subject. NOTE: In common usage, CRF can refer to either a CRF page, which denotes a group of one or more data items linked together for collection and display, or a casebook, which includes the entire group of CRF pages on which a set of clinical study observations and other information can be or have been collected, or the information actually collected by completion of such CRF pages for a subject in a clinical study. (CDISC v 9.0)

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