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
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
Use of Competencies
•
•
•
•
•
•
•
Competency Profiles Competency-Based Training Job Profiles – Linked – Person Profiles
Level of Competency vs Level of Job
Self-Assessment and Competence
Competence and Career Development
Gap Analysis • Training to Fill Gaps
• Continuous Process (Competence Not Static,
Jobs Change, Gaps Appear); Lifelong
Learning
Competency Domains for the Clinical Research Professional
51 Specific
Competency
Statements
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
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
Purpose of a Job Analysis
Job Analysis: Systematic
Process for Identifying What
is IMPORTANT
CONTENT AREAS
(DOMAINS)
TASKS:
WHAT YOU DO
KNOWLEDGE:
WHAT YOU NEED TO KNOW TO
COMPETENTLY PERFORM THE TASKS
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…”)
The New DCO –
What’s the
Difference?
2010 – 2016 EXAMS
INVESTIGATIONAL
PRODUCT
MANAGEMENT
SAFETY
2017 EXAMS
PROTOCOL
SCIENTIFIC
CONCEPTS &
RESEARCH DESIGN
ETHICAL &
PARTICIPANT SURVEY
CONSIDERATIONS
TRIAL MANAGEMENT
PRODUCT
DEVELOPMENT &
REGULATION
CLINICAL TRIAL
OPERATIONS
(GCPS)
STUDY AND SITE
MANAGEMENT
DATA
MANAGEMENT &
INFORMATICS
TRIAL OVERSIGHT
Job Analysis Results: Differential
Weighting of Content By Job Role
= Test Specifications
PercentageofQuestionsonExam
CCRA
CPI
CCRC
I. ScientificConceptsandResearchDesign
12%
17%
8%
II. EthicalandParticipantSafetyConsiderations
20%
25%
22%
III. ProductDevelopmentandRegulation
10%
10%
14%
IV. ClinicalTrialOperations(GCPs)
25%
15%
22%
V. StudyandSiteManagement
23%
23%
22%
10%
10%
12%
100%
100%
100%
ContentAreas
VI. DataManagementandInformatics
Total
Detailed
Content Outline
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
Professional
Development
Pathways
5.ClinicalTrial
Management
CRAs
CRCs
PIs
Managementofanindividualclinicaltrialatanindividualsite.
Basic
1.Subjectsafety
management/
adverseevent
reporting
2.Subjectselection,
screeningand
recruitment,
recruitment
plan/strategies,
recruitmentskills
3.Informedconsent
Intermediate
Comprehension/
Application
Mastery
Comprehension/
Application
Mastery
Comprehension/
Application
Mastery
4.Good
documentation
practices,casereport
form,source
documentation
development,useand Comprehension/
monitoring
Application
Mastery
5.Required
Reporting(IRB/IEC,
Sponsor,Institution
Comprehension/
e.g.)
Application
Mastery
Advanced
Basic
Mastery
Comprehension/
Application
Mastery
Comprehension/
Application
Comprehension/
Application
Mastery
Comprehension/
Application
Mastery
Comprehension/
Application
Mastery
Intermediate
Mastery
Advanced
Basic
Intermediate
Advanced
Mastery
Comprehension/
Application
Mastery
Mastery
Mastery
Mastery
Mastery
Mastery
Mastery
Mastery
Mastery
Mastery
Comprehension/
Application
Comprehension/
Application
Mastery
Comprehension/
Application
Mastery
Mastery
Mastery
Comprehension/
Application
Mastery
Mastery
Mastery
Mastery
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
Courses by
Competency
Driving
Adoption
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??
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
THANK YOU
TERRI HINKLEY, ACRP
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INTEGRATION OF THE CORE COMPETENCY FRAMEWORK