1. Workforce Development Domain Task Force
The WF DTF Lead Team
Rebecca Jackson (Ohio State)
Richard Barohn (Kansas)
Carrie Byington (Utah)
Lee Nadler (Harvard)
Christine Sorkness (Wisconsin)
Joan Nagel (NCATS)
Lynda Lane (C4)

2. Workforce Development Domain Task Force IOM Report - NCATS ACWG
The translational science workforce has the skills and knowledge necessary to advance translation of discoveries.
This goal focuses on:
Building an environment that supports and values translational science as “the place to go” for those who want to pursue high-impact careers in health sciences.
Training, educating and providing all members of the research team with the skills sets and tools needed to advance the field of translational science
Developing a translational science workforce that can meet the needs of today and tomorrow.

3. Specific Goals for WF Development
Incubator for novel training models, core competencies and fundamental skill sets
Be more inclusive, provide more flexible learning modules for all members of the workforce e.g. GCP training platform
Embrace Innovative Curricula and Team-Based Education and Training
entrepreneurship, regulatory science, community engagement
Recruit and support diverse research team members who are underrepresented in translational science research
Provide a plan to facilitate the dissemination of educational resources to promote flexible learning tools and schedules for all members of the workforce

4. Highlights of WF Development Working Groups-Supplements
1. Clinical Research Training for Investigators
2. GCP Module Development for Social-Behavioral Research Teams
3. Harmonizing Competencies to Facilitate Personalized Pathways
4. Towards a Sustainable Career in TS
5. New Opportunities

5. 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

6. 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

7. 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

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

9. Workgroup Leads: Nancy Calvin-Naylor and Christy Byks-Jazayeri
GCP Module Development for Social/Behavioral Research Teams NCATS Goal: provide more flexible learning modules for all members of the workforce e.g. GCP training platform
Workgroup Leads: Nancy Calvin-Naylor and Christy Byks-Jazayeri

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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.)
Demo

16. 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.

17. Polling question Social and Behavioral Research Training Modules
Once available would you offer Social and Behavioral GCP Research Training as an alternative to meet traditional GCP training requirements for social and behavioral scientists?
Yes No
Don’t Know

18. WG Leads: Beth Knutson and Rebecca Jackson
Harmonizing Competencies to Develop Personalized Education and Career Development Pathways NCATS GOAL: incubator for core competencies and fundamental skill sets
WG Leads: Beth Knutson and Rebecca Jackson

19. Harmonizing Competencies
Problem – Relevance and usefulness of the Clinical and Translational Research Core competencies to CTSA hubs could be better defined.
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 practices/335-2/
Other competencies that emanate from CTSA efforts – Regulatory Science, Informatics, how to harmonize and reduce redundancy
Key Deliverable: Refining core competencies to reduce overlap and increase usefulness to CTSA consortia with reorganization BY topics and target audiences

20. 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

21. 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

22. 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…..

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

24. 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)

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

26. Polling question Education and Training of Translational Scientists
Are you utilizing the clinical and translational science research competencies that are on the C4 website?
Yes No
What website?

27. Polling question Education and Training of Translational Scientists
Do you believe competencies are of added value to translational science researchers?
Yes No

28. Polling question Education and Training of Translational Scientists
Are you currently mapping the competencies into your training programs?
Yes No

29. Working group Leads: Carrie Byington and Christine Sorkness
Towards a Sustainable Career in Translational Science NCATS Goal: incubator for novel training models
Working group Leads: Carrie Byington and Christine Sorkness

30. Background
Success of a sustainable and diversified biomedical workforce is dependent on programs that cultivate talented translational researchers, mentoring them to independent long term careers
Need to identify best “K to R” practices from CTSA KL2 programs, and key program elements that contribute to success
Need to disseminate “best practices” across the CTSA consortium

31. Robinson GFWB et al. Academic Medicine 2016 Apr; 91(4):570-82.
Understanding Career Success & Contributing Factors
Personal Factors
Networking
Persistence & resilience
Initiative
Autonomy
Personal & professional balance
Organizational Factors
Mentor(s) & mentorship
Protected Time
Institutional resources & support
Robinson GFWB et al. Academic Medicine 2016 Apr; 91(4):

32. Action Plan
KL2 program survey of current “best practices” in the contemporary CTSA era
Ascertainment of impact of these practices on career success, broadly defined as “continued employment in translational science”
Inclusion of both traditional and non-traditional metrics to reflect roles in team science
Survey to be informed by expertise and publications of CTSA KFC leaders
CTSA Common Metrics to be included

33. 4/13/16 WDDTF Roundtable Discussion: Career Sustainability
Definition of “career sustainability,” inclusive of multiple pathways
Capture of CTSA program support of other academic K and individual K scholars
Extent of formal mentor training in KL2 program and processes aimed to diversify the workforce
Time frame for the survey responses ( )
ID of WG, Chair/Co-Chair, timeframe for construct, administration, and dissemination of survey; ID of support needed
Suggestions on the draft survey framework

34. Polling question Towards a Sustainable Career in CTS
All CTSA KL2 programs should offer formal K to R grant writing sessions.
Yes No
Don’t know

35. Polling question Towards a Sustainable Career in CTS
All CTSA KL2 programs should mandate formal mentor training?
Yes for both the KL2 mentor and the KL2 scholar
Yes for the KL2 mentor (with an option for the KL2 scholar) No

36. Polling question Towards a Sustainable Career in CTS
The number of KL2 positions allowed in the CTSA program?
Not Enough
Enough
Too many

37. New WF Development Collaborative Opportunities
New WF Development Collaborative Opportunities Research Process Improvement for Physician-Scientist MOC Collaboration with FDA on Federated Educational Platform The WF DTF as a Resource for Education and Training Initiatives

38. Research Process Improvement for Physician-Scientist MOC
Maintenance of Certification (MOC) is required by 21/24 ABMS Boards
An option for part IV MOC is to credit QI activity sponsored by institutions
Aligns professional development with organizational quality & safety improvement goals to improve efficiency and reduce physician burden
Surveys suggest that these QI activities do not reflect the needs of physician scientists

39. Proposal: Research QI for MOC
Purpose: Assess feasibility and pilot the application of Research QI project to meet part IV requirement
Define Research QI Portfolio Program standards and guidelines requirements for meaningful participation
Pilot program at 2-4 CTSA programs to determine burden (to institutions and individuals)
Why should CTSA Consortium Collaborate with ABMS?
Aligned with NCATS and CTSA Consortium goals to increase TS research efficiency
Career Development/Sustainability Benefits
Reduce burden to physician scientists
Align MOC activities with career development goals

40. Polling question Research QI for MOC
Should the CTSA Consortium (or WF DTF) collaborate with ABMS on Research QI Pilot as an option for MOC for physician-scientists?
Yes No
Not sure

41. Update on a Federated Education Network
Informatics Development of Federated Network
Federated network quick to deploy, low (shared) costs, flexibility, ability to customize, local control over data
Ontology-based organization of resources allows for more granular identification of resources of interest
Embedded metrics and assessments
Innovation grant submitted and under review for proof-of-concept development and testing
Current Activities Supporting Federated Network
Elucidation of personal pathways in DTF
To be leveraged for development of initial decision support tools
Increase collaboration with other stakeholders
More detailed engagement of FDA and Pharma in development

42. The WF DTF as a Resource for Education and Training Initiatives
“Coming together is a beginning.
Keeping together is progress.
Working together is success.”
Henry Ford

43. Discussion Are we addressing the most critical gaps and issues that will positively impact a sustainable clinical and translational science workforce?