Transcript Enhancing Clinical Research Professionals` Training

ECRPTQ Project Update
RICHARD BAROHN, UNIVERSITY OF KANSAS
THOMAS SHANLEY, NANCY CALVIN-NAYLOR, UNIVERSITY OF MICHIGAN
Project Leadership

Thomas Shanley MICHR (UM)*

Nancy Calvin-Naylor MICHR (UM)

Richard Barohn Frontiers (KU)*

Vic Divecha MICHR (UM)

Todd Wilson NCATS
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Catherine Radovich MICHR (UM)
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Abby Bronson NCATS
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Kay Wilson MICHR (UM)
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Jonelle E. Wright Miami
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Karen Blackwell Frontiers (KU)
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Karl Kieburtz Rochester
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Edward Ellerbeck Frontiers (KU)

Eric Rubinstein Rochester
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Kirsten Erickson Frontiers (KU)
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Harry P. Selker Tufts
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Jamie Caldwell Frontiers (KU)
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Jonathan Davis Tufts
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Jennifer Maddox Frontiers (KU)
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Margaret J. Koziel UMass
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Michelle Wartak Tufts

Katherine Luzuriaga, UMass

Pamela Tenaerts CTTI

Michael Fleming NUCATS
*Co-PIs
“Enhancing Clinical Research Professionals’
Training and Qualification”
Background
Enhancing Clinical Research Professionals’ Training and Qualification

project seeks to improve the efficiency, safety and quality of clinical
research, as well as reduce redundant training requirements.
Aims
1.
Standardize training in Good Clinical Practices (GCP) across the CTSA
network (Phase 1)
2.
Competency-based training for clinical trial professionals: A high-level
framework of competency domains and harmonized competencies.
(Phase 2)
Scope

All 62 CTSA hubs
Phase 1: Standardize GCP training
September 2014 to February 2015
Sept. - Oct. 2014

Leadership team convened, analysis CTSA Hubs engaged in planning
Nov. 2014 – Dec 2014
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Phase 1 meeting in Chicago, All 62 hubs represented
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Recommendations drafted and circulated for consensus by hubs
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Recommendations endorsed by all 62 hubs
Jan. 2015 – Feb 2015
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Recommendations formally presented to NCATS leadership
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Discussed at Steering Committee
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Discussed at CTSA PI Meeting in DC

Metrics working group proposed evaluation framework impact of
competency based programs: Program success, Impact – Streamlining
the process, Process, and Comparative effectiveness
Phase 1 Recommendations

All study personnel engaged in executing a drug, device, biologic
and/or behavioral intervention*--as defined by the NIH--should be
trained in the fundamental principles of Good Clinical Practice
(GCP).


*A separate GCP training module for behavioral interventionists will be developed
The method selected for GCP training should:

Meet the minimum criteria for International Conference on
Harmonization (ICH) Good Clinical Practice training.
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Be accepted as “common currency” by industry sponsors so as to
eliminate redundant training requests.
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Research personnel should take GCP training every three years, c/w
the current clinical research training organizations and industry
expectations.
Phase 1 Recommendations

The recommendations contained in the
accompanying document were reviewed by 84
individuals representing all 62 CTSA hubs and
endorsed unanimously.

Recommended process be implemented by the
end of calendar year 2015.
The recommendations have been endorsed by NCATS and the NCATS CTSA Steering
Committee. The next step is to determine the mechanism by which the Phase 1
recommendations will be implemented.
Phase 1: Impact

Raises the clinical research standards of the CTSA network (at
least to the level of industry)

Aligns with NCATS initiative to partner with industry on site
qualification (IOM)

Positions the CTSA network to better accommodate multi-site
clinical studies

Represents the first national CTSA initiative to include all CTSA
hubs

Identification & addressing of gap: GCP-like training for
social/behavioral interventionists
Phase 2: Competency-based training for clinical
trial professionals
A high-level framework of competency domains and
harmonized competencies
Phase started: December 2014

Dec 2014-Jan 2015

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Feb-March 2015

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Review and Selection of Competency Frameworks
Competency Domain Working groups
April 2015 –

Competencies review & synthesis
Dec 2014 – Jan 2015
Review and Selection of
Competency Framework
Selected: Joint Task Force for Clinical Trial
Competency
9 working groups formed for each
competency domain
I.
SCIENCE & DESIGN
II.
ETHICS & SAFETY
III.
DRUG, DEVICE, INTERVENTIONS DEVELOPMENT
AND REGULATION
IV. CLINICAL TRIAL OPERATIONS (GCP)
V.
STUDY AND SITE MGMT
VI. DATA AND INFORMATICS
VII. LEADERSHIP AND PROFESSIONALISM
VIII. COMMUNICATION
IX.
TEAMWORK
Moving from Compliance to Competency: A Harmonized Core
Competency Framework for the Clinical Research Professional PEER
REVIEWED | Stephen A. Sonstein, PhD | Jonathan Seltzer, MD, MBA,
MA, FACC | Rebecca Li, PhD | Honorio Silva, MD | Carolynn Thomas
Jones, DNP, MSPH, RN | Esther Daemen, BSN, PG, PMP, MBA [DOI:
10.14524/CR-14-00002R1.1]
CLIINCAL RESEARCHER, JUNE 2014 http://www.coapcr.org/wpcontent/uploads/2014/10/Clinical-Research-Competencies.pdf
Phase 2: Competency-based training for clinical trial professionals
Phase started: December 2014
A high-level framework of competency domains and harmonized competencies

Competency Domain Working groups
 Charge:
 Harmonize JTF competencies, identify gaps and edit
competencies necessary to be qualified to execute
clinical trials: PI & CRC
 Identify resources, assessments, training tools,
providers
 Progress:
 Working groups formed in advance of the Dallas
meeting
 Met F2F in Dallas, continued work, and presented to
attendees
 Submitted draft deliverable (March 23) and final
deliverable (April 1)
 NOW: Synthesis of working group deliverables by a
CTSA/JTF review team
 Presentation to JTF meeting at ACRP Global
Working Groups’ Deliverable

A description of what a competent Investigator and Clinical Research
Coordinator (CRC) conducting clinical trials ought to be able to do
(i.e., a set of competency statements for each role)
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A description of training that exists to support the development of
competence for study team personnel conducting clinical trials
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A description of training gaps that might exist for study team
personnel conducting clinical trials
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Recommendations for assessment of competence for study team
personnel conducting clinical trials
Project next steps
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Dallas meeting summary & Phase 2
recommendations
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Attendee endorsement
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Steering committee review
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Recommendations to NCATS
Training for social/behavioral (SB) research
personnel conducting clinical trials
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GCP training for SB

Recommendations for SB interventions training