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IND/IDE Monitoring Services

Published on · Last Updated 1 year 2 months ago


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The Office of Research Compliance (ORC) will provide monitoring services for CHOP investigational new drug (IND) or investigational device exemption (IDE) sponsors. The ORC will monitor IND/IDE studies using a risk-based approach to monitoring. ORC will assess compliance with the protocol, IND/IDE application, IRB application, and federal regulations. CHOP IND/IDE sponsors and sponsor-investigators will be provided with a written report of any observations, as well as best practice recommendations, following the conclusion of each visit.

For any questions or requests related to IND/IDE monitoring services, please contact Karen Burke.