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Sunday, 12/17/2017 11:20:12 AM

Sunday, December 17, 2017 11:20:12 AM

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Site/Clinical Monitoring - The sponsor or a group under contract to the sponsor generally performs site/clinical monitoring of a clinical trial to assure high quality trial conduct. They perform "on site" monitoring of individual case histories, assess adherence to the protocol, ensure the ongoing implementation of appropriate data entry and quality control procedures, and in general assess adherence to good clinical practices. In blinded studies, these monitors remain blinded to study arm assignment.

https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf

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