Investigators' Guide to Investigator Site Audits

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The RQA is committed to the conduct of the highest quality clinical research. As part of that commitment, and for compliance with Good Clinical Practice (GCP) requirements, RQA has developed this guide to help investigators prepare and understand the activities and rationale for auditing investigator sites.

Contents

1. Why are Audits Performed?
2. How are Investigator Sites Selected for Audit?
3. What is Good Clinical Practice?
4. What will the Audit Involve?
5. Investigator Site Audit Flowchart
6. Regulatory Inspections
7. Further Information

Authors

RQA GCP Committee 

ISBN

978-1-904610-23-6

Published

February 2013

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