Terri Hinkley, RN, BScN, MBA, CCRC Deputy Executive Director, ACRP

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1 INTEGRATION OF THE CORE COMPETENCY FRAMEWORK INTO THE ACRP CAREER DEVELOPMENT PATHWAY, LINKAGE OF EDUCATION AND TRAINING PROGRAMS WITH COMPETENCIES AND NEXT STEPS Terri Hinkley, RN, BScN, MBA, CCRC Deputy Executive Director, ACRP

2 The Joint Task Force for Clinical Trial Competency Organized Under Sponsorship of MRCT and ACRES at Harvard University Supported by MAGI, DIA and ACRP Included Representatives from Industry, Academia and Nonprofit Organizations Agreed to Work Toward Aligning and Harmonizing the Many More Focused Statements Relating to Core Competencies for Clinical Research Professionals into a Single, High-Level Set of Standards Which Could be Adopted Globally Serve as a Framework for Defining Professional Competence throughout the Clinical Research Enterprise

3 Use of Competencies Competency Profiles Competency-Based Training Job Profiles Linked Person Profiles Level of Competency vs Level of Job Training to Fill Gaps Continuous Process (Competence Not Static, Jobs Change, Gaps Appear); Lifelong Learning Self-Assessment and Competence Competence and Career Development Gap Analysis

4 Competency Domains for the Clinical Research Professional

5 51 Specific Competency Statements

6 THERE MUST BE A CONCERTED EFFORT BY ALL STAKEHOLDERS TO INTEGRATE THE JTF DOMAINS AND COMPETENCIES INTO EXISTING PRODUCTS AND SERVICES, WORKFLOW, JOB DESCRIPTIONS, TRAINING PROGRAMS AND HIRING PRACTICES

7 Competencies as a Foundation As Requirement of Accreditation and to Have Defensible Exam, ACRP Conducts Job Analysis Survey (JAS) Every 5 Years Provides Data Needed to Construct a Reliable, Objective Professional Development Pathway Validates the Knowledge, Skills and Abilities (KSAs) Required of Clinical Research Professionals and Serves to Define Domain Areas for ACRP Certification Exams ACRP Conducted JAS in 2015

8 Purpose of a Job Analysis Job Analysis: Systematic CONTENT AREAS (DOMAINS) TASKS: WHAT YOU DO Process for Identifying What is IMPORTANT KNOWLEDGE: WHAT YOU NEED TO KNOW TO COMPETENTLY PERFORM THE TASKS

9 The Survey Organized into Six Domains Taken from Joint Task Force (JTF) Competency Framework for Clinical Research Professionals 135 Task Statements 88 Knowledge Statements Some Statements Written Broadly to Encompass a Variety of Roles ( Develop or Review ) Some Statements Broken Out Specifically ( Verify. vs. Conduct )

10 The New DCO What s the Difference? EXAMS 2017 EXAMS INVESTIGATIONAL PRODUCT MANAGEMENT PROTOCOL SCIENTIFIC CONCEPTS & RESEARCH DESIGN ETHICAL & PARTICIPANT SURVEY CONSIDERATIONS SAFETY TRIAL MANAGEMENT PRODUCT DEVELOPMENT & REGULATION CLINICAL TRIAL OPERATIONS (GCPS) TRIAL OVERSIGHT STUDY AND SITE MANAGEMENT DATA MANAGEMENT & INFORMATICS

11 Job Analysis Results: Differential Weighting of Content By Job Role = Test Specifications Percentage of Questions on Exam Content Areas CCRA CPI CCRC I. Scientific Concepts and Research Design 12% 17% 8% II. Ethical and Participant Safety Considerations 20% 25% 22% III. Product Development and Regulation 10% 10% 14% IV. Clinical Trial Operations (GCPs) 25% 15% 22% V. Study and Site Management 23% 23% 22% VI. Data Management and Informatics 10% 10% 12% Total 100% 100% 100%

12 Detailed Content Outline

13 Professional Development Pathways ACRP Developed PD Pathways to Assist Clinical Researchers in Determining the Knowledge and Expertise they Should Have Specific to their Experience Level and Role in Clinical Research PD Pathway Foundation: JAS from 2010 PD Pathways Developed for CRCs, CRAs and PIs

14 Professional Development Pathways 5. Clinical Trial Management Management of an individual clinical trial at an individual site. 1. Subject safety management/ adverse event reporting 2. Subject selection, screening and recruitment, recruitment plan/strategies, recruitment skills Basic Intermediate Advanced Basic Intermediate Advanced Basic Intermediate Advanced 3. Informed consent 4. Good documentation practices, case report form, source documentation development, use and monitoring 5. Required Reporting (IRB/IEC, Sponsor, Institution e.g.) CRAs CRCs PIs

15 Next Steps: Full Integration PD Pathways to be Updated Based on Domain Areas of t e JTF and Results of the JAS Work to link ACRPs programs to domain areas underway Collaborative Process with Industry Stakeholders Dissemination and Adoption

16 Courses by Competency

17 Driving Adoption

18 CRA Competency Development: Driving Adoption CRA shortage Arbitrary 2 year experience requirement from sponsor for CRAs to be billable CROs require new hires to have 2 years of monitoring experience How can one get experience when they can t get a job??

19 CRA Workforce Development Task Force: Driving Adoption ACRP-Led Initiative Participation from Sponsors, CROs, Educational Institutions and Academic Medical Centers Mapping CRA Competencies from JTF Domains for EntryLevel, Mid-Level and Experienced CRAs

20 THANK YOU TERRI HINKLEY, ACRP