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Title Perceptions of clinical research coordinators about the quality of monitoring and major failings/concerns in the monitoring process
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Publication Date
Degree MS
Discipline/Department Health Sciences
Degree Level masters
University/Publisher Eastern Michigan University
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.
Subjects/Keywords research; clinical trials; monitoring; Medicine and Health Sciences
Contributors Stephen A. Sonstein, PhD, Chair; Ronald F. Maio, D.O., MS; Irwin Martin, PhD
Rights Open Access Thesis
Country of Publication us
Record ID oai:commons.emich.edu:theses-1850
Repository emich
Date Retrieved
Date Indexed 2020-01-02
Created Date 2013-04-01 07:00:00

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…of Responses to Monitoring Practice Questions .......................................... 46 Appendix A: College of Health and Human Services Human Subjects Review Committee Approval Letter…

…conduct research or a survey involving human subjects (Clinical Research Coordinators) to the College of Health and Human Services Human Subjects 9 Review Committee (CHHS-HSRC) at Eastern Michigan University. The CHHS-HSRC approved…

…the study to conduct the survey on November 7, 2012. (Appendix A: College of Health and Human Services Human Subjects Review Committee Approval Letter). All of the potential participants were informed clearly about the purpose of the study…

…Biochemistry, and Biology), (c) Health Science degree (e.g. Clinical Laboratory Science, Physical Therapy), (d) Clinical Research degree, (e) Other (Please Specify). The objective of this question was to…

…evaluate whether a majority of the clinical research coordinators hold a clinical research degree. 13 As shown in Table 2, 28.7% of respondents have a life science degree like pharmacy, biochemistry, and biology, 21.8% of respondents have a health

health, statistics, psychology, and clinical social work. Question 3: Which of the following best describes your current work setting? Survey respondents were asked to select from the following options: (a) Private Practice site, (b)…

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