1. Joint Workgroup on Researcher Training & Education and Community Capacity Building: Collaboration/Engagement & Workforce Development Domain Task Forces
Co-Leads:
Al Richmond, MSW, Executive Director,
Community-Campus Partnerships for Health
Hal Strelnick, MD, Albert Einstein College of Medicine
Hugh Tilson, DrPH, University of North Carolina
Staff:
Leslie R. Boone, MPH, C4
Annual Meeting
Association of Clinical & Translational Science
Washington, DC
April 13-15, 2016

2. Joint Workgroup Co-Leads
Hugh Tilson, MD, MPH, DrPH, University of North Carolina
Al Richmond, MSW, Executive Director,
Community-Campus Partnerships for Health

3. Statement of Purpose From IOM report on The CTSA Program at NIH:
Recommendation 5: Advance Innovation in Education and Training Programs
“the CTSA program should emphasize innovative education and training models and methodologies, which include a focus on team science, leadership, community engagement, and entrepreneurship; disseminate high-quality online offerings for essential core courses ”
Recommendation 6: Ensure Community Engagement in All Phases of Research
“ensure that patients, family members, health care providers, and other community stakeholders, as well as clinical researchers, are involved across the continuum of clinical and translational research”

4. Curricula & Training Programs: Focus of Joint Workgroup
Goal: identify what is being taught to promote collaborative , community-academic, translational research
Curricula & Training Programs:
Focus of Joint Workgroup
Investigators & Researchers
Community Members & Stakeholders T1 T2 T3 T4
Academic Health Sciences Center & University
Community

5. Strategy & Key Objectives
Conduct a pragmatic literature review of curricula and training resources
for researchers in engaging communities & stakeholders in translational research and
for building community capacity to participate in translational research (3 months);
Develop an annotated (and searchable) inventory of existing curricula and training resources (6-9 months);
Conduct a gap analysis of important areas requiring further development (3 months); and
Identify best practices where evidence-based curricula are available, (1-2 months).

6. Key Deliverables
A pragmatic literature review of curricula and training resources that builds academic researchers’ capacity to engage communities & stakeholders and community capacity to collaborate in translational research;
An annotated inventory of existing curricula and training resources;
A gap analysis of important areas for future development;
Dissemination through peer-reviewed publications of the pragmatic literature review findings and the annotated inventory of existing curricular and resources;
Identification of evidence-based best practices and resources currently under development;
Examples of successful programs, including contact information for those with questions; and
Recommendations for dissemination to and adoption by CTSA hubs and NCATS.

7. How You Can Help Identify a Co-Lead from the Workforce Development DTF
Identify additional members from Workforce Development DTF
Complete beta-test of survey instrument for environmental scan of curricula and trainings at the community-academic interface
Thank you!

9. Clinical Research Training for Investigators NCATS Goal: provide more flexible learning modules for all members of the workforce e.g. GCP training platform
WG Leads: Jonelle Wright and Richard Barohn

10. Clinical Research Training for Investigators - Overview
Purpose:
Create on-line practical trainings to build investigators’ operational knowledge and logistical skills in protocol development and implementation
Background:
In addition to learning the scientific method, clinical investigators need to know the “how-tos” of safe and competent research
There is widespread demand for investigator training on the operational aspects of clinical and translational studies

11. Clinical Research Training for Investigators – Approach
Focus
Basic operational aspects of clinical studies
Stages of the study lifecycle
Workgroup
13 members representing 10 institutions, FDA, and professional organizations
Cincinnati
Miami
Penn State Hershey
Stanford
Tufts
FDA
ACRP

12. Clinical Research Training for Investigators – Action Plan
Game Plan
Review ECRPTQ Competency Domains/Statements
Decide fundamental core curriculum
Decide course/module content
NIH Collaboratory

14. GCP Module Development for Social/Behavioral Research Teams
Nancy Calvin-Naylor, PhD
Christy Byks-Jazayeri
University of Michigan
Workforce Development Domain Task Force
April 13, 2016

15. Background
Enhancing Clinical Research Professionals’ Training & Qualifications (ECRPTQ) – Phase 1, GCP
Requested a no-cost extension to develop online training
Launched design work in Summer 2015 with Innovative Learning Group (ILG)
Issued an RFP for module development in Fall 2015
Vendor selected and work began in January 2015

16. Vendor Information Torrance Learning www.torrancelearning.com
Chelsea, MI
Torrance team:
Megan Torrance, CEO
Jen Vetter, Project Manager
Contracted for 9 modules not to exceed 2-3 hours total
Video, photographs, audio, and animation including pre- production (scripting, storyboarding) and post- production (editing) using Articulate Storyline
Deliverable = 9 files ready to upload to a SCORM1.2- compliant learning management system

17. Content Development
Susan Murphy (U-M) led a team with expertise in social/behavioral research who organized content around GCP principles
The team mapped the GCP principles to the ECRPTQ competencies
Iterative process with Torrance to produce scripts/storyboarding based on input from subject matter experts

18. Module Outline Module 1: Introduction, Roles & Responsibilities
Module 2: Research Protocol
Module 3: Informed Consent Process
Module 4: Confidentiality/Privacy
Module 5: Recruitment/Retention
Module 6: Participant Safety/Adverse Event Detection & Reporting
Module 7: Quality Control/Assurance
Module 8: Research Misconduct
Module 9: Conclusion/Summary

19. Approach Interactive – learners do not just read blocks of text
Engaging – material is dynamic
Relevant – content developed by SMEs
Based on learning theory
Focused on helping learners acquire competence through skills tests embedded in modules

20. Access NCATS will host the modules on its servers
CTSA hubs can download the modules
Institution-specific material can be appended to the modules as needed
Modules can then be uploaded on institutional servers and metrics tracked as appropriate (e.g., number of views, scores on assessments, etc.)

21. Social/Behavioral GCP Working Group
Faculty Lead: Susan Murphy, MICHR, University of Michigan
Administrative Lead: Christy Byks-Jazayeri, MICHR, University of Michigan
Alecia Fair, Vanderbilt University
Alison Miller, University of Michigan
Angie Lyden, University of Michigan
Blair Holbein, UT Southwestern
Catherine Radovich, University of Michigan
Edward Ellerbeck, University of Kansas
James Giordano, Georgetown University
James Spilsbury, Case Western University
Jen Miner, University of Michigan
Jenna Rouse, ACRP
Kelly Unsworth, University of Rochester
Laura Denton, University of Michigan
Laura Fluharty, University of Pennsylvania
Laurie Lester, Dartmouth College
Lise Anderson, University of Michigan
Mary-Tara Roth, Boston University
Nancy Calvin-Naylor, University of Michigan
Nicole Exe, University of Michigan
Penny Jester, University of Alabama
Rebecca Brouwer, Duke University
Susan Rose, University of Southern California
Teri Hinkley, ACRP
Valerie Kahn, University of Michigan
Vic Divecha, University of Michigan
Additional thanks to all SMEs, Alpha reviewers and Beta testers from across the CTSA consortium.

22. Demo

23. Questions?

24. Harmonizing Competencies
Problem – Relevance and usefulness of the Clinical and Translational Research Core competencies to CTSA hubs could be better defined. The fundamental skills sets and a clear pathway needed by the Translational Science workforce is not clear (IOM report)
Defining Target audiences for translational research core competencies
How are core competencies being used across CTSA hubs?
Other competencies that emanate from CTSA efforts – Regulatory Science, Informatics, how to harmonize and reduce redundancy
Personalized Pathway
Key Deliverable: Refining core competencies to reduce overlap and increase usefulness to CTSA consortia with reorganization BY topics and target audiences

25. CTSA Working Group Competencies
CEnR-Competencies with Learning Objective
CER Competencies
Informatics Competencies
CTSA Special Interest Competencies
CTSA Core Competencies for Masters Degree
Regulatory Science Competencies
nihms other cer
Combined have identified over 70 competencies

26. What are the Workforce Roles?
The following are referenced in CTSA competency publications
K Scholar
T Scholar
MS Research Scholar PI
Research Coordinator
Community Engagement
Pediatric Researcher
T1 Researcher
Academia Industry Drug Development
Biostatisticians
Informaticians
Collaborating Physician
Medical Device and Tech Transfer
Clinical Trial Researcher

27. CTSA Working Group Competencies
CEnR-Competencies with Learning Objective
CER Competencies
CTSA Core Competencies for Masters Degree
CTSA Special Interest Competencies
Informatics Competencies
nihms other cer
Regulatory Science Competencies
K Scholar
T Scholar
MS Research Scholar PI
Research Coordinator
Community Engagement
Pediatric Researcher
T1 Researcher
Academia Industry Drug Development
Biostatisticians
Informaticians
Collaborating Physician
Medical Device and Tech Transfer
Clinical Trial Researcher
This question led to a new proposed framework for harmonizing and mapping competencies and educational pathways…..

28. Harmonizing Competency Framework
Operationalize Definition of CTS Roles
Overlay identified competencies, reducing redundancies
Personalized Educational Pathway

29. Operationalize Definition of CTS Roles
Overlay identified competencies reducing redundancy
Personalized Educational Pathway
Defining Roles
One individual could theoretically need competencies across multiple published competencies.
For example: An MD trainee in an MS degree program with an interest in pediatric medical device research
What competencies might this individual draw from?
CTSA Core Competencies for Master’s Candidates
CTSA Special Interest Competencies (Pediatrics)
CTSA Special Interest Competencies (Medical Devices)
What educational pathways might this individual seek?
K or T Scholar Programs (institution specific)

30. Approach: Personalized Career Trajectory Decision Tree
For sake of space, this is illustrated as a unidimensional hierarchy

31. Questions for Discussion
How are hubs utilizing published competencies?
What would make it easier for you to identify all the competencies that should be developed for your various CTS workforce roles?
Does the Decision Tree approach to role identification work?
Can you plug in examples that do work?
Examples that don’t fit these questions?
If a menu of competencies and education pathways can be produced for the combinations of roles (as identified by Decision Tree), would that help you in developing educational training and programming?