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Monitoring & Auditing of Clinical Trials

Monitoring & Auditing of Clinical Trials Sponsored by Center for Cancer Research National Cancer Institute Objectives Guidelines suggest that following the good Clinical research practice of Monitoring / Auditing should be done for the reasons previously stated. That is why, whether you participate in FDA regulated research or not, there should be some local policies and procedures in place for the routine evaluation ( , an audit) of a Clinical trial. At the conclusion of this module you will be able to: Describe the purposes and regulations related to Monitoring of Clinical Trials .

•Monitoring and auditing of clinical trials is necessary to assure that the: •rights and safety of patients (i.e., human subjects) are protected •reported trial data are accurate, complete, and verifiable from source documents •conduct of trial is in compliance with protocol, good clinical practice (GCP) and applicable regulatory

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