Wheel reinventors take note: A compliance tool

May 2010
Clinical Trials Administrator;May2010, Vol. 8 Issue 5, p53
The article focuses on the Good Clinical Practice (GCP) guidelines developed by the University of Pennsylvania School of Medicine to assist investigators in learning about regulations, best practices in protocol development and compliance. Some of the documents that principal investigators need to collect before the start of a study include personnel qualifications, approval documentation and enrollment. A description of the protocol template of the GCP is provided. It relates the items included in the protocol evaluation checklist. INSET: Compliance keys for drug studies.


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