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Essential Documentation in Clinical Trials Trailer

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Uploaded by on Jun 23, 2010

Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, Best Practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance.

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