Date Approved

4-2013

Date Posted

9-19-2013

Degree Type

Open Access Thesis

Degree Name

Master of Science (MS)

Department

Health Sciences

Committee Member

Stephen A. Sonstein, PhD, Chair

Committee Member

Ronald F. Maio, D.O., MS

Committee Member

Irwin Martin, PhD

Abstract

The primary goals of clinical research monitoring are to assure adequate protection of the rights of human subjects, and the safety of all subjects involved in clinical investigations or clinical trials, and the quality and integrity of the data generated from clinical trials. Adequate monitoring of clinical trials can prevent the occurrence of significant problems, which may affect the entire process of bringing a new drug to market. The proper monitoring of clinical trials is a challenge. In spite of well established regulations and guidance, there remain many monitoring related concerns in clinical trials (e.g. protocol deviations and violations, IRB violations, improper adverse event reporting, etc). The survey results indicate that clinical research coordinators believe that there are concerns in the monitoring process, and that the quality of monitoring varies from monitor to monitor. Results also suggest that some monitors are exceptional, where as some monitors are abysmal.

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