Introduction. Objectives

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1 A Research Personnel Model to Maximize Compliance Carol Fedor, RN, ND, CCRC Director, Human Research Protection Program Center for Clinical Research and Technology University Hospitals Case Medical Center HCCA Research Compliance Annual Conference Austin, Texas June 1, 2013 Introduction Challenges that impact Research Sites: Regulatory burden on investigators Protected time for investigators to conduct research Recruitment and retention of research participants Retention of qualified clinical research personnel Economic pressures AMCs less likely able to support funding gaps between contracts/grants Inadequate clinical research personnel allocation in budget Overall inadequate budget 2 Objectives 1. Identify alternative model for effectively managing clinical research personnel. 2. Analyze benefits of a centralized clinical research personnel pool to the overall operations and management of research personnel in an academic medical center (AMC). 3 1

2 Background Clinical research coordinators (CRC) function in many roles and emerge as the key figure in the clinical research process. Recruitment/enrollment Regulatory documentation Data management Study visit assessments Informed consent Adverse event management Managing the Investigators 4 Background Often, CRCs are hired by a principal investigator under the auspices of an institution based on the availability of grant funding. Research personnel are typically based within the department (decentralized) and report to the PI and/or Administrator. 5 Proposition Centralized oversight and support of research personnel has operational advantages Efficiency Cost savings Continuity of funding Availability of backup personnel Uniform performance of personnel Improve collaborative research environment Uniform operating procedures and training that improve compliance Uniform standards for the qualifications and experience of support personnel 6 2

3 Case Study University Hospitals Case Medical Center (UHCMC) in Cleveland, Ohio established a research support core program to build a clinical research infrastructure within the Center for Clinical Research and Technology (CCRT) to support the research community with qualified Clinical Research Specialists on an as needed fee-for-service basis. 7 Model Centralized across 21 academic and clinical departments in the AMC. Standardized competencies of positions and job descriptions of all clinical research personnel. Established governance by central research administration. 8 Model (continued) A centralized framework providing uniform oversight and ensuring efficiency and cost distribution. Consistent approach to study management. Professionalizes clinical research support personnel. Flexibility and coverage increased. 9 3

4 Institutional Collaboration: Research and Human Resources CRC job descriptions were developed into task specific positions based on the level of responsibilities with Department of Human Resources and representatives from the clinical and academic departments. Goal to streamline job titles and descriptions to promote career development and increase retention. Positions were developed based on a grid matrix: years of clinical research experience, education, research certifications and responsibilities associated with the role. 10 Center for Clinical Research: Support Services TYPE OF ROLE OR POSITION Clinical Research Nurse Specialists Clinical Research Specialists Clinical Research Regulatory Specialists Research Finance Specialists Grant Support Specialists Clinical Research Data Specialists LEVELS/JOB DESCRIPTIONS (Levels I to IV) (Levels I to III) (Levels I to III) (Levels I to III) (Levels I and II) (Levels I to III) 11 Research Regulatory Specialist Career Pathway Matrix Job Level Experience Education Responsibilities Research Regulatory Specialist I Research Regulatory Specialist II Research Regulatory Specialist III 2 years in a health-related or research field Associate s degree preferred; degree can substitute for years experience 3 years of clinical research Bachelor s degree required; years of experience and research certification (i.e., SoCRA or ACRP) can offset degree requirement 3 years of clinical research regulatory OR 5 years of clinical research Required bachelor s degree AND advanced degree or research Certification (SoCRA or ACRP) See General Job Description Includes responsibilities of the RRS-I job description and coordinates multiple or complex studies or/and investigator initiated IND-IDE held studies with minimal supervision. Prepares FDA submissions for IND or IDE held Investigator Initiated Trials. Assists Principal Investigators with protocol and consent writing. Provides mentorship on the clinical trial and regulatory process to less experienced staff members. Includes responsibilities of the RRS- II and assists with workload review of team and provide guidance on task prioritization. Mentors new hires in training on departmental processes and policies. Assists in SOP development. Oversees and implements department wide projects. Projects require research, organization, 12 4

5 Personnel Requirements The Clinical Research Specialists (CRS) have extensive experience in the coordination and management of a clinical trial. Individuals are credentialed in their specialized area of research conduct or administration. CRS receive training (CCRT) to be experts in regulatory requirements and comply with institutional policies. 13 Process: Request for Research Support Investigator meeting to identify protocol specific support Complete Research Specialist Request Form (requires grant account number) Identify Research Specialist level/personnel who best fits the project Request Form reviewed by Director, Human Research Protection Program and Vice President for Research Develop orientation for CRS to department and assignment 14 Research Administration Operations Research Request Form Time Tracking Defining Activities Cross-charging (post award grant accountants) 15 5

6 CRS Request Form SECTION 1 Instructions: Please complete the following form and to carol.fedor@uhhospitals.org Principal Investigator (PI) Date of request (MM/DD/YY) Title/Position Department Division Phone Number/Pager Project Short Title: IRB #: Approval date: Funding Source Federal Funded Industry-sponsored Foundation Department Investigator Initiated Projected start date (MM/DD/YY): Projected end date (MM/DD/YY): % FTE Estimate: Financial contact Account number (PTAEO) Drug Study? Device Study? No Yes No Yes Will the W.T. Dahms Clinical Research Unit (DCRU) be used? No Yes Department Review Completed? Yes No If the DCRU will not be used, please list the location(s) for the study visits: SECTION 2 Brief Study description (Provide Copy of Protocol & Consent Form): Categories of Research Support Site qualification Site Initiation Case Report Form development Regulatory Binder Investigator/team training Coverage analysis Protocol development IND/IDE Applications to FDA Study visit conduct Data collection Informed Consent IRB documentation Adverse event reporting Drug/device accountability FDA/Sponsor audit prep Monitoring 17 10/1/ University Hospitals Case Medical Center Time Tracking Hours Study Start-Up 0.00 ClinicalTrials.gov Registration 0.00 Coverage Analysis and Pre-Qualification Forms Assistance 1.00 Contract/Agreement/financial/coordination setup support IRB New Study Application 5.00 Protocol Development 0.00 Regulatory Binder Creation/Set-Up 2.00 Required Training 5.00 Site Initiation/Protocol Implementation 1.00 Sponsor Correspondence 0.00 Study Document Creation 0.00 Study PI/Sponsor Educational Training 6

7 Time Tracking Hours: Study Maintenance 0 Adverse Event Reporting 0 Case Report Forms Edits/Change 3 Data Management 0 Data Safety Monitoring Report Assistance 0 Investigator/Team Meeting 0 iris Protocol Registration 0 Meeting Minute Documentation 7 Protocol Amendment 18 Protocol Continuing Review 0 Protocol Deviation Report 1 Regulatory Binder Organizational Assistance 1 Required Training 0 Study PI/Sponsor Educational Training 0 Subject Recruitment Strategies Time Tracking Hours IND/IDE Assistance 0 Annual Report Assistance 0 FDA Protocol Amendment Submission 0 Final Report Assistance 0 IDE Application Assistance 0 IND Application Assistance 0 Med Watch Report Submission 0 Monitoring Plan Evaluation 0 Pre-IND Application 0 Pre-IDE Application 0 Protocol Analysis for IND/IDE Determination 0 Study PI/Sponsor Educational Training Institutional Research Support Core Development First Research Specialist hired Hired second Regulatory Specialist Hired 2 additional Regulatory Specialists and 1 Regulatory Nurse Specialist Hired 1 Regulatory Specialist and 1 Research Nurse Specialist Department 11 Protocols Total 3 Departments 20 Protocols Total 6 Departments 46 Protocols Total 9 Departments 111 Protocols Total 14 Departments 208 Protocols 21 7

8 Results To date these five positions included in this pilot have participated in the management or conduct of 203 clinical protocols based across 14 clinical departments and provide support to more than 90 investigators. 22 Research Support Core Growth Total Projects by Department University Hospitals Total Projects 213 Total Projects 18 Departments

9 Advantages of Model Research Specialists are hired, trained and supervised by the central research office and have access to entire research administration office. IRB administration, pre-award, post-award, research billing, research compliance and education Specialists have extensive experience (4 10 years), certified clinical research professionals, advanced degrees (Master s) and are required to complete the Clinical Research Orientation program. Emphasis on education to advance role FDA and the Office of Human Research Protections (OHRP) conferences Individualized training in IRB submission processes 25 Business Model: Growth and Quality of Site Performance Increased regulatory compliance with ability to effectively submit documents efficiently to the IRB and to the FDA when required. Increased implementation of complex investigator initiated protocols at UHCMC that met enrollment quotas efficiently; without the expertise of the research support core, these types of protocols can be high risk to the institution. Increased research funding due to increased start-up potential of studies in the institution and increased enrollment due to qualified personnel available within the support core. Engage new PIs without resources. 26 Lessons Learned Transitioning existing support personnel under central research administration. Improves job security Reinforces clinical research career paths. Expands training and educational knowledge base (e.g. IND\IDE regulatory filings, research billing related topics, GCP) Increased human subject protections for higher risk protocols. 27 9

10 Conclusions (continued) Impact on industry funded-clinical trial budgets while producing real time results. Institutions often offset the costs of conducting clinical trials because investigators may underestimate the percent effort required by study personnel to complete all required aspects of a trial; research support core model realistically captures the actual cost of those functions. Industry will likely support these actual costs if in return protocols are conducted with increased efficiency, improved human subject protections and with increased data integrity. 28 Future State Grow to meet demands Collaborate in assessing study feasibility Transition existing positions under the central administration hierarchy. Expands educational support available based on knowledge of Specialists Build institutional reputation and minimize non-compliance. 29 References Cola, P., Mihalus, S., and Fedor, C. Prioritizing Clinical Research Resources: Development of a Centralized Research Support Core, Monitor, Lloyd-Damnjanovic, A. & Rome, H. (2011). Research in jeopardy: scientists fear funding loss. The Daily Princetonian. Published: Wednesday, April 6 th, Bloom, F. E. (2003). Science as a way of life: Perplexities of a physician-scientist. Science, 300(5626), Dickler, H.B., Korn, D., & Gabbe, S. G. (2006). Promoting translational and clinical science: The critical role of medical schools and teaching hospitals. PloS Medicine, 3(9), Sung, N. S., Crowley, W. F.,Jr, Genel, M., Salber, P., Sandy, L., Sherwood, L. M., et al. (2003). Central challenges facing the national clinical research enterprise. JAMA : The Journal of the American Medical Association, 289(10), Huang, A. J. (1999). Reinventing the physician-scientist in the new era of health care. JAMA : The Journal of the American Medical Association, 281(1), 94. Kim, S, Ubel, P, De Vries, R. Pruning the regulatory tree. Nature. 2009; 457:

11 References (Continued) Sugarman, J. (2000). The role of institutional support in protecting human research subjects. Academic Medicine, Vol. 75 (7), Fedor, C. & Cola, P.A. (2003). The Coordinators Forum: Preliminary results of the Clinical Researcher Coordinators Survey. Clinical Researcher, 3 (4), Fedor, C.A. (2006). Chapter 1: The evolving role of the clinical research coordinator. Responsible Research: A Guide for Coordinators. Edited by Carol A. Fedor, Philip A. Cola & Christine Pierre. Remedica Publishing, London, UK. Pages Fedor, C.A. & Gabriele, E.F. (2006). Chapter 13: Future trends: the professionalization of the CRC. Responsible Research: A Guide for Coordinators. Edited by Carol A. Fedor, Philip A. Cola & Christine Pierre. Remedica Publishing, London, UK. Pages Acknowledgement and Thank You The presenters wish to acknowledge the support of the other members of the Research Support Core who contributed data: Lisa Archer Jill Bradisse, MA, CCRP Carmen Czich, RN, CCRP Kirk Krogstad Sonya Mihalus, RN, CCRC Jenna Stump, MS, CCRP 32 11