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ERIC Number: EJ888524
Record Type: Journal
Publication Date: 2008
Pages: 10
Abstractor: As Provided
ISSN: ISSN-1539-1590
Development and Progression of a Model: Prospective Research Compliance Monitoring
Fedor, Carol; Ferrazzano Yaussy, Cristina; Cola, Philip A.
Journal of Research Administration, v39 n2 p41-50 Fall 2008
Recent trends in Human Research Protection Programs (HRPPs) have contributed to the rising emphasis on prospective monitoring of clinical research and education programs. Therefore, internal efforts and resources to monitor investigator compliance and site performance have become an important focus in the conduct of clinical research. Once the science and ethics of the research is approved by the Institutional Review Board (IRB), the investigator has the overall responsibility for conducting the research, protecting human subjects, and providing periodic reports and updates related to the research to the IRB. Any potential non-compliance issues that arise during the conduct of the study will be reported to the IRB and potentially prompt decisions about the continuation of the study. Nevertheless, institutions should recognize that IRB review processes, investigations of noncompliance and prospective monitoring are distinct components within an HRPP. The Center for Clinical Research and Technology (CCRT) at University Hospitals Case Medical Center (UHCMC) recently implemented a prospective monitoring and education program and collected data to evaluate the program's development. Trends associated with resource utilization, monitoring procedures and educational activities of the program will be presented, as well as an analysis of the impact of the program. (Contains 3 tables and 1 figure.)
Society of Research Administrators International. 500 North Washington Street Suite 300, Falls Church, VA 22046. Tel: 703-741-0140; Fax: 703-741-0142; e-mail:; Web site:
Publication Type: Journal Articles; Reports - Descriptive
Education Level: Adult Education
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A
Identifiers - Location: Ohio