Development and Progression of a Model: Prospective Research Compliance Monitoring

TitleDevelopment and Progression of a Model: Prospective Research Compliance Monitoring
Publication TypeJournal Article
Year of Publication2008
AuthorsFedor, C, Yaussy, CFerrazzano, Cola, PA
JournalJournal of Research Administration
Volume39
Issue2
Pagination41-50
Date Published2008
Publication Languageeng
ISBN Number15391590
KeywordsCurricula , education , EXPERIENTIAL , information , management , Prospective , research , Responsible , Scientific , University , VIGILANCE
AbstractRecent 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. 
NotesFedor, Carol 1; Email Address: carol.fedor@uhhospitals.org; Yaussy, Cristina Ferrazzano 2; Email Address: cristina.ferrazzanoyaussy@uhhospitals.org; Cola, Philip A. 3; Email Address: philip.cola@uhhospitals.org; Affiliations: 1: Clinical Research Manager, Center for Clinical Research and Technology, University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, Ohio 44106, USA; 2: Research Compliance Specialist, Center for Clinical Research and Technology, University Hospitals Case Medical Center; 3: Vice President for Research and Technology, Center for Clinical Research and Technology, University Hospitals Case Medical Center; Issue Info: 2008, Vol. 39 Issue 2, p41; Thesaurus Term: INFORMATION services; Thesaurus Term: RESEARCH; Thesaurus Term: MANAGEMENT science; Subject Term: SCIENTIFIC knowledge; Subject Term: EXPERIENTIAL research; Subject Term: EDUCATION -- Aims & objectives; Subject Term: CURRICULA (Courses of study); Subject Term: VIGILANCE (Psychology); Subject Term: UNIVERSITY hospitals; Author-Supplied Keyword: prospective monitoring; Author-Supplied Keyword: research administration; Author-Supplied Keyword: research compliance; Author-Supplied Keyword: responsible conduct of research; NAICS/Industry Codes: 519190 All Other Information Services; Number of Pages: 10p; Illustrations: 3 Charts, 1 Graph; Document Type: Article

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