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UUSOP - 6 (STUDY RECORDS MANAGEMENT) is a Course

UUSOP - 6 (STUDY RECORDS MANAGEMENT)

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The purpose of this SOP is to describe the methods for the collection and maintenance of study records in the conduct of clinical research at the University of Utah and applicable covered entities.FDA regulations and GCP guidelines require the investigator and institution to maintain all information in original records of clinical findings, observations or other activities in clinical research necessary for the reconstruction and evaluation of the study. Subject-specific records (study participant charts) are compiled for each study subjectand contain source documentation of research records such as the signed informed consent form, medical history, medication logs, treatment records, protocol assessment results, and adverse events. General study records such as current and past versions of the study protocol and informed consent form, IRB approvals, investigator’s brochure, training records, delegation of authority log, and monitoring reports are maintained in the regulatory binder.Not all documents will be consistently utilized for every type of study but in general, the principles of this procedure will be the same across all types of clinical research.

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