1. www.postersession.com Methods References Background Utility of Framework CLINICAL RESEARCH CORE COMPETENCIES AND GLOBAL SITE ACCREDITATION: OPPORTUNITIES FOR EDUCATION AND CAPACITY BUILDING IN CLINICAL RESEARCH Carolynn T. Jones, DNP, MSPH; Marjorie V. Neidecker, PhD, MEng; Kimberly J. Arcoleo PhD, MPH; and Cynthia A. Carnes, PharmD, PhD Clinical research has expanded globally requiring evolutions across regulatory bodies and stakeholders to improve the enterprise. The development and adoption of guidelines from the International Conference on Harmonization and the development of online registries such as clinicaltrials.gov have been a key part of the transformation in clinical research. A need for greater transparency in clinical trial data and evolving clinical research methodology have brought about open communication between pharmaceutical sponsors and regulators leading to the formation of harmonization across groups. The development of role delineation studies and core competency statements by different groups has stimulated a need to better define the work of clinical researchers and their associated learning needs. In keeping with these evolutions the Joint Task Force (JTF) for Clinical Trial Competency was formed, comprised of representatives of Academic Medical Center Sites, Contract Research Organizations, pharmaceutical companies and clinical research professional societies. This group has defined a list of eight core competency domains. Educational needs assessments for clinical research professionals and the formation of the Consortium of Academic Programs in Clinical Research (CoAPCR) in 2003 stimulated a multi-stage research-based approach to defining core competencies (CC) for academic curriculum development and plans for future accreditation pathways. 2010-12 CoAPCR CCs harmonized from six sources using a Delphi approach resulting in publication (Jones, et al, 2012) Academy of Pharmaceutical Physicians and Investigators (APPI) International Federation of Associations of Pharmaceutical Physicians (IFAPP) NIH Clinical Research Nurses 2010 Oncology Nursing Society (ONS) United Kingdom National Competency Framework for Clinical Research Nurses National Center for Advancing Translational Sciences (NCATS) & Clinical and Translational Science Awards 2012-13 Formation of Commission on Accreditation for CoAPCR, endorsed by and membership to accrediting body: Commission on Accreditation of Academic Allied Health Educational Programs (CAAHEP.org). 2013 JTF formation expanded the work of CoAPCR Core Competency harmonization to include stakeholders groups, those hiring clinical research professionals to their workforce- resulting in publication (Sonstein, et al,2013). CoAPCR Multiregional Clinical Trial Center (MCTC- Harvard University Regulatory Affairs Professional Society (RAPS) Academy of Physicians in Clinical Research (APCR) Association of Clinical Research Professionals (ACRP) Alliance for Clinical Research Excellence and Safety (ACRES) Clinical & Translational Science Awards (CTSA) Clinical Trials Transformation Initiative (CTTI) Collaborative Institutional Training Initiative (CITI) Deloitte Drug Information Association (DIA) Global Health Network Inter-American Foundation for Clinical Research (IFCR) International Academy for Clinical Research International Federation of Associations of Pharmaceutical Physicians (IFAPP) 2014-15 JTF and CoAPCR as stakeholder contributors to ACRES Site Accreditation and Standards Initiative. Development of a research plan to validate CC: Global Survey of CC *, disseminated to clinical research professionals (a) self-assess relevance of CC to their “work”; (b) educational needs assessment. (in process), disseminated to US and global site personnel. Survey in India: https://www.surveymonkey.com/r/LFWW883 (Jan, 2015)https://www.surveymonkey.com/r/LFWW883 The CC survey has expedited IRB approval from Eastern Michigan University, (Principal Investigator: Stephen Sonstein, PhD) ACRES: http://www.acresglobal.net/http://www.acresglobal.net/ Bhatt A 2007. The challenge of growth in clinical research: Training gap analysis. Pharma Bio World. Carter SC, Jones CT, Jester PM 2007. Issues in clinical research managers education and training. Research Practitioner 8:48-60. CoAPCR: http://www.coapcr.orghttp://www.coapcr.org Executive Office of the President. 2012. PCAST report on Propelling Innovation in drug discovery, development and evaluation. http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-fda-final.pdf http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-fda-final.pdf Gupta, UC 2012 Quantitative evaluations of GCP training needs in clinical research. Asian Journal of Pharmaceutical and Clinical Research 5(3);165-167. International Conference on Harmonisation: http://www.ich.orghttp://www.ich.org Institute of Medicine. 2012. Envisioning a transformed Clinical Trials Enterprise in the United States. Establishing and Agenda for 2020. Workshop Summary. Washington DC: National Academies Press. Jones CT, et al. 2012. Defining Competencies in Clinical Research: Issues in Clinical Research Education and Training Research Practitioner 13(2):99-107. Misik V, Brady RV, Bolecek M, Klech M 2014 Current trends in globalization of Industry sponsored clinical trials. Applied Clinical Research, Clinical Trials and Regulatory Affairs 1(1): 56-66. Sonstein S, Seltzer J, Li R, Silva H, Jones C, Daemen E 2014. Moving from Compliance to Competency: A harmonized Core Competency Framework for the Clinical Research Professional. Clinical Researcher 28(3): 17-23. Speicher, et al. 2012. The critical need for academic health centers to assess the training, support and career development of clinical research coordinators: recommendations from the clinical and translational science award research coordinator taskforce. Clinical and Translational Science 5(6):470-5. Transcelerate: http://www.transceleratebiopharmainc.com/http://www.transceleratebiopharmainc.com/ Clinical research capacity building Curriculum development & training initiatives Investigator certification Site approvals and selection Site accreditation Defining career ladders and levels Job descriptions and evaluations Policy development Quality improvement Academic program accreditation Professional certification Global innovation exchange Improved performance outcomes in the global clinical research enterprise Global Clinical Research System ACRESglobal.net Novice Competent Expert Master of Applied Clinical and Preclinical Research, The Ohio State University, Colleges of Nursing, Pharmacy & Medicine 100% Online Curriculum: Clinical Research Management | Regulatory Affairs | Clinical Pharmacology | Safety Pharmacology macpr.osu.edu The development and validation of the CC for clinical researchers will provide a roadmap for benchmarking clinical research performance. Leveling of CC from novice to expert will inform job titles, progression and appropriate delegation and oversight. The implications of adopted CC to training programs, accreditation of academic educational programs, and site accreditation standards are recognized. Upon analyses of survey data, a future aim will be to gain recognition of the CC by global regulatory bodies for the formation of a guideline similar to ICH GCP E6. The ultimate goal is quality, safety and adherence to GCPs. Conclusion