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

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

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”

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

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).

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.

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!

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

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

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

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

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

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

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

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

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

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

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.)

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.

Demo http://torrancelearning.com/clients/michr/goldilocksdemo/

Questions?

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 https://ctsacentral.org/consortium/best-practices/335-2/ 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

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 nihms228803 other cer Combined have identified over 70 competencies

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

CTSA Working Group Competencies CEnR-Competencies with Learning Objective CER Competencies CTSA Core Competencies for Masters Degree CTSA Special Interest Competencies Informatics Competencies nihms228803 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…..

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

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)

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

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?