Monitoring the Monitors - Applied Clinical Trials

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Monitoring the Monitors
Guidelines and a checklist ensure those responsible for subject safety and data validity are doing their jobs.
Sep 1, 2007
By: Sarah White, Delia Wolf, Lucy Feild
Applied Clinical Trials

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12. Code of Federal Regulations, Title 45 CFR Section 164.514 (U.S. Government Printing Office, Washington, DC).

13. Health and Human Services, OCR Privacy Brief, Summary of the HIPAA Privacy Rule, http:// http://www.hhs.gov/ocr/privacysummary.rtf (Accessed May 2007).

14. D. Wolf and P. O'Rourke, "Ensuring Investigator Compliance and Improving Study Site Performance: Implementing a Quality Assurance and Quality Improvement Program in Academic Health Centers," Clinical Researcher, 2 (5) 2–14 (2002).

Sarah White* is a senior quality improvement/assurance specialist, QI Program, Partners Healthcare Systems, 116 Huntington Ave, 10th Floor, Boston, MA 02116, email: swhite12@partners.org
. Lucy Feild, PhD, RN, is a senior quality improvement/assurance specialist and Delia Wolf, MD, JD, is director of the QI Program at Partners Healthcare Systems.

*To whom all correspondence should be addressed.

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Source: Applied Clinical Trials, 9/1/2007
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