The SRA Symposium - College of Medicine

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Papers The Development, Implementation and Evaluation of a Prospective Research Monitoring Program Philip A. Cola, MA, Principal Author Center for Clinical Research University Hospitals of Cleveland 11100 Euclid Avenue Cleveland, OH 44106, USA (216) 844-5568 Philip.Cola@uhhs.com Carol Fedor, ND, CCRC, Co-Author Center for Clinical Research University Hospitals of Cleveland 11100 Euclid Avenue Cleveland, OH 44106, USA (216) 844-5568 Carol.Fedor@uhhs.com and Louise Haffke, RN, MPH, Co-Author Center for Clinical Research University Hospitals of Cleveland 11100 Euclid Avenue Cleveland, OH 44106, USA (216) 844-5568 Louise.Haffke@uhhs.com Authors Note: The opinions in this paper are those of the authors and do not reflect the official policy of the Center for Clinical Research, University Hospitals of Cleveland. Mr. Philip Cola is the corresponding author and can be contacted as above. Abstract: Historically, monitoring of clinical research predominantly occurred in industry-funded studies through which Clinical Research Coordinators (CRCs) and Principal Investigators (PIs) were audited by external sponsor-provided “monitors”. The purpose of this paper is to evaluate preliminary results of an internal pilot prospective monitoring program. This program was developed and implemented to proactively enforce responsible conduct of research, to monitor the informed consent process, to serve as a support service to CRCs and PIs, to ensure clinical research data integrity, and to investigate overall research compliance. This program differs from the historical monitoring model in its prospective informed consent monitoring, its internal implementation and relationship to the Institutional Review Board (IRB) for compliance matters, its attempt to proactively improve data integrity, and its potential to monitor clinical research that is not currently audited (i.e., certain Federally or Foundation-sponsored or investigator-initiated trials). 66 2005 Symposium Proceedings Book
Data results will evaluate the impact of internal prospective monitoring on human subject protections and data integrity by virtue of quality improvement activities. Furthermore, internal prospective monitoring will provide an opportunity through which the “compliance monitor” may evaluate non-compliance trends and identify needed areas of continuing research education for CRCs and PIs which promotes the responsible conduct of research. Introduction: Papers The various roles of research administrators have become increasingly broad as this discipline moves toward continued professionalization. Research administrators are responsible for the legal, fiscal, ethical, scientific and compliance reviews of protocols from their inception and that responsibility continues beyond protocol or grant completion. In the past, research administrators were viewed as predominantly grant or IRB administrators. The profession has grown and currently research administrators include grant writers, CRCs, human subject protection and compliance specialists, investigator support personnel and research billing professionals. This development has lead to increased awareness and understanding of the crucial roles that research administrators play in the conduct of both basic science and clinical research. A particular area that has gained considerable momentum recently has been the role of the clinical research compliance monitor or specialist. Similar to other academic or business specialties, the process of conducting clinical research is heavily monitored and historically this monitoring has been performed by external sources (i.e., the sponsor, contract research organization, or Federal agencies). During the past decade it has become evident that relying solely on external monitoring is insufficient to maintain the responsible conduct of research in light of the tremendous growth in clinical research during this period in the United States. Not only has Federal funding for research doubled in the past decade, but from 1997 to 2000, the estimated number of participants in Federally funded research increased from 7 million to 12 million. Non-Federally sponsored research has grown at a similar pace (Slater, 2002). These trends have driven the desire and need to create internal research compliance monitoring functions in an effort to improve research programs and to provide supportive services to investigators that allow them to conduct clinical research effectively. Some institutions have developed these programs in response to specific compliance findings discovered by external monitoring activities (Steinbrook, 2002a). Such shortcomings in Human Subject Protection programs at major institutions should serve as a catalyst for all institutions, researchers and IRBs that are charged with not only promoting clinical advances, but first and foremost, protecting the human subjects involved in the process (Shalala, 2000). Additionally, the continuing education of research administrators and institutional officials make it clear that internal compliance auditing programs that proactively monitor clinical research at the institution are necessary. Research institutions must commit to regular and routine internal auditing of all research activities. Critical self-examination can bring to light weaknesses and other issues before significant errors occur (Icenogle, 2003). It is believed that in order for research compliance programs to be effectively related to other areas of research administration (i.e., the administrative functions of an IRB and grant accounting), the compliance programs should be established in Offices of Sponsored Projects at Universities and Clinical Trial Offices of the Hospital arms of Academic Medical Centers (AMCs). Research compliance monitoring is not merely a routine monitoring function of these types of institutions, but rather a specialized monitoring function that enhances the overall research administration effort. 2005 Symposium Proceedings Book 67
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2005 Symposium Proceedings The SRA
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Dear Colleagues and Friends, Octobe
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Table of Contents Karen M. Wilson.
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Poster Abstracts
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Poster Abstracts Poster Abstract 20
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Page 40 and 41: Papers The principles of respect fo
Page 42 and 43: Papers The narrative approach, on t
Page 44 and 45: Papers References Agre, P., Campbel
Page 46 and 47: Papers Potts, A., Grace, V., Gavey,
Page 48 and 49: Papers Introduction Day by day soci
Page 50 and 51: Papers Brent: Karl has been a great
Page 52 and 53: Papers Karl: During my time at the
Page 54 and 55: Papers Work Hard. Another very impo
Page 56 and 57: Papers External Resource Acquisitio
Page 58 and 59: Papers Generally speaking, fundrais
Page 60 and 61: Papers Organizations and websites t
Page 62 and 63: Papers Public HBCUs and smaller chu
Page 64 and 65: Papers There are key databases avai
Page 66 and 67: Papers 2. Basic Institutional Compo
Page 68 and 69: Papers The Utility of Gender, Race,
Page 70 and 71: Papers As a three hospital health c
Page 72 and 73: Papers References Amdur, R., Banker
Page 74 and 75: Papers • Dramatic Growth in Resea
Page 76 and 77: Papers • Cross Unit Collaboration
Page 80 and 81: Papers Background: IRBs in AMCs hav
Page 82 and 83: Papers Institutional Quality Improv
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Page 86 and 87: Papers References: Burke, G.S. (200
Page 88 and 89: Papers Table 1 Total Number of Prot
Page 90 and 91: Papers Sunday, December 7, 2003. D
Page 92 and 93: Papers Similarly, the OGE audit ind
Page 94 and 95: Papers Changes to 5 C.F.R. §5501.1
Page 96 and 97: Papers * * * However, § 5501.106(c
Page 98 and 99: Papers 4. Conclusion The NIH Februa
Page 100 and 101: Papers Within the context of a mana
Page 102 and 103: Papers As illustrated (Figure 1) th
Page 104 and 105: Papers Figure 3. Recommendation lev
Page 106 and 107: Papers References Australian Vice-C
Page 108 and 109: Papers The Problem and Its Statemen
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Page 112 and 113: Papers Table 1: Survey Respondents
Page 114 and 115: Papers Conclusions With the creatio
Page 116 and 117: Papers APPENDIX 2 I. Research Admin
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Page 120 and 121: Papers Even if prospective subjects
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Page 124 and 125: Papers 4) Heuristics: Since the con
Page 126 and 127: Papers Hochhauser, M. Informed Cons
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Papers How “readable” are conse
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Papers of vowels per word, some on
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Papers followed by 39 side effect b
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Papers References Chall, J.S. & Dal
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Papers Coping involves the effort t
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Papers Conclusion Defense mechanism
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Papers of Pennsylvania in 2000. In
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Papers for board members, reviewing
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Papers Focusing on “Development
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Papers Figure 1: Total UB Internal
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Papers Figure 3: Academic staff vie
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Papers Respondents’ evaluations o
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Papers 140 2005 Symposium Proceedin
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Papers ing proposals, the greater t
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Papers Abstract “Best Practices
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Papers INSTITUTIONAL ERA PLANNING A
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Papers process than an end product;
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Papers realization of the benefits
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Papers State and private institutio
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Papers Institutions of higher educa
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Papers Typically, all interactions
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Papers Figure 2 There are nine pers
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Papers Questions that can be discus
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Papers Using the innovation success
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Papers students in non-science subj
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Papers For example, to address inno
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Papers The second is the Botswana T
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Papers manpower is not trained, and
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Papers European and Federal Funding
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Papers As the majority of US Univer
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Papers Integrated Project Duration
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Papers up to these terms (called
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Papers Collective responsibility -
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Papers • Revised implementation p
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Papers Conclusion SRA is an interna
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Papers Virgin Territory: The Role o
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Papers and in which disciplines. Th
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Papers a historically black univers
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Papers Benefits of Working with Jun
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Papers Human Subjects Research and
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Papers observational and could do v
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Papers ted on patients at l’Hopit
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Papers The pastor of the Bergen hos
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Papers it was at any rate an imposs
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Papers The Environmental Protection
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Papers of the restriction on the he
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Papers Mentoring and Motivating: Br
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Papers more importantly, individual
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Papers with little or no cash outla
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Papers better outcomes for areas th
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Papers attention of the research of
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Papers discussion of each prepropos
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Papers Appendix A Sample Feedback N
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Papers Introduction Certification p
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Papers The list of certified resear
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Papers Research Question 2 What is
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Papers 8. Twenty-nine percent (29%)
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Papers individuals outside their or
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Papers References Bratton, B. & Hil
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Papers Never let your sense of mora
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Papers Lakoff (2002) describes inte
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Papers place blame at the feet of i
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Papers Lower, G. (2005, June 27). W
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Papers Institute of Ecosystem Studi
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Papers • Collaborative research p
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Papers How Administrators Can Help
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Papers How to Develop a Centralized
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Papers The current trend of selecti
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Papers References Kaiser Daily Heal
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Papers Evaluation of Strategies for
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Papers on research activity; manage
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Papers 4. Introduction of encourage
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Papers Table 1 Research Attitudes -
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Papers Constraints When staff were
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Papers Houston, D. & Studman, C.J.,
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Papers to look at the technologies
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Papers areas of responsibilities. T
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Symposium Future Proposals
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Symposium Future Proposals Symposiu
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Symposium Future Proposals Symposiu
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