1. ECRPTQ Project Update RICHARD BAROHN, UNIVERSITY OF KANSAS THOMAS SHANLEY, NANCY CALVIN-NAYLOR, UNIVERSITY OF MICHIGAN

2. Project Leadership  Thomas Shanley MICHR (UM)*  Richard Barohn Frontiers (KU)*  Todd Wilson NCATS  Abby Bronson NCATS  Jonelle E. Wright Miami  Karl Kieburtz Rochester  Eric Rubinstein Rochester  Harry P. Selker Tufts  Jonathan Davis Tufts  Margaret J. Koziel UMass  Katherine Luzuriaga, UMass  Michael Fleming NUCATS  Nancy Calvin-Naylor MICHR (UM)  Vic Divecha MICHR (UM)  Catherine Radovich MICHR (UM)  Kay Wilson MICHR (UM)  Karen Blackwell Frontiers (KU)  Edward Ellerbeck Frontiers (KU)  Kirsten Erickson Frontiers (KU)  Jamie Caldwell Frontiers (KU)  Jennifer Maddox Frontiers (KU)  Michelle Wartak Tufts  Pamela Tenaerts CTTI *Co-PIs

3. “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

4. 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  Phase 1 meeting in Chicago, All 62 hubs represented  Recommendations drafted and circulated for consensus by hubs  Recommendations endorsed by all 62 hubs  Jan. 2015 – Feb 2015  Recommendations formally presented to NCATS leadership  Discussed at Steering Committee  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

5. 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.  Be accepted as “common currency” by industry sponsors so as to eliminate redundant training requests.  Research personnel should take GCP training every three years, c/w the current clinical research training organizations and industry expectations.

6. 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.

7. 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

8. Phase 2: Competency-based training for clinical trial professionals  Dec 2014-Jan 2015  Review and Selection of Competency Frameworks  Feb-March 2015  Competency Domain Working groups  April 2015 –  Competencies review & synthesis A high-level framework of competency domains and harmonized competencies Phase started: December 2014

9. 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/wp- content/uploads/2014/10/Clinical-Research-Competencies.pdf http://www.coapcr.org/wp- content/uploads/2014/10/Clinical-Research-Competencies.pdf 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 Review and Selection of Competency Framework Dec 2014 – Jan 2015

10. Phase 2: Competency-based training for clinical trial professionals  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 A high-level framework of competency domains and harmonized competencies Phase started: December 2014

11. 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)  A description of training that exists to support the development of competence for study team personnel conducting clinical trials  A description of training gaps that might exist for study team personnel conducting clinical trials  Recommendations for assessment of competence for study team personnel conducting clinical trials

12. Project next steps  Dallas meeting summary & Phase 2 recommendations  Attendee endorsement  Steering committee review  Recommendations to NCATS  Training for social/behavioral (SB) research personnel conducting clinical trials  GCP training for SB  Recommendations for SB interventions training