Liz Wool was an invited expert speaker at this meeting in Chicago, IL, USA, Novemeber 2014. Attendees of this first meeting included representatives from each of the current 62 CTSA institutions; Todd Wilson, DO, the National Center for Advancing Translational Sciences’ (NCATS) program director; and key stakeholders, including representatives from the pharmaceuticals industry and the Federal Drug Administration (FDA). The meeting was led by co-PIs Tom Shanley, MD, from MICHR, and Richard Barohn, MD, from Frontiers, the Kansas University Medical Center’s CTSA hub. For more information, go to http://www.ctsa-gcp.org/1st-meeting-chicago.html.

1. Beyond Basic GCP Training
Liz Wool, BSN, CCRA, CMT
President & CEO
Franklin, TN
NIH CTSA Meeting: Invited Expert Presentation
November 3, 2014
Chicago, IL USA
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©Copyright 2014 QD-Quality and Training Solutions, Inc. All Rights Reserved
DUNS: 045313628 CAGE Code: 726J8

2. Invited
Speaker -
Faculty
ConferencesFaculty
Federal
Conferences
Invited
Speaker
OHRP
Regional
Educational
Conferences
ORI
Quest for
Excellence
Conference
GCP Faculty
UC Berkeley
San
Francisco
State
University
ACRP
DIA
Barnett
Invited
Speaker
HCCA
SRA
SoCRA
ACRP
DIA
• California
Pacific Medical
Center
• Cincinatti
Children’s
• Columbia P NY
• Dartmouth-
Hitchcock
• Stanford
• University
Hospitals
Cleveland
• UCSF
• Univ Colorado
• Univ
Rochester
Experience
35 years
healthcare
24 years CR
• JHH
Research
Nurse
• Sponsor
• CRO
• Military
Medicine
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3. Liz Wool
3
Regulatory Affairs Committee
Past Member, Board of Trustees
Leader
GCP Quality Metrics Work Group

4. QD-QTS
• Founded: 2007
• Clients: AHCs, NIH, National Healthcare Organization
• GCP Training: SME, development, delivery
– Role-based: Institution, Organization
• Training Plans, On-the-job training
• Curricula: Targeted, relevant topics
• Focus: Performance
• Focus: Competencies
• GCP Quality, Compliance, Risk Management
• Team of consultants
4

5. Platform Capabilities
5

6. Platform Capabilities
• Current client
– National Healthcare Organization
– Customized GCP e-modules
• Adobe® Captivate
• Upload into CITI system to deploy for their
organization
– Check with platform providers for similar
capability
6

7. 7
Innovation & Advancements
Humankind

8. Performance
Management
“Equip our Research Teams”
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9. Educate: Knowledge
Train: Skill
Demonstrate: Behavior - Ability
Competent = Qualified
Perform Independently
Performance Management
9

10. 10
‘COMPETENT’
DEEMED QUALIFIED
10

11. Joint Task Force for
Clinical Trial Competency
Cognitive
Domains
“Granular
Performance
Aspects Defined
by” the
Organization
11
Sonstein,S., et.al, Moving from Compliance to Competence:
A Harmonized Core Competency Framework for the Clinical Research Professional,
Clinical Researcher, 2014

12. SMART REPRODUCIBLE
SIMPLE
ACHIEVABLE
LOW TECH GLOBAL
QUALITY
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13. Job
Description
Scope of
Practice
Job Function
Trg Plans
Scope of
Employment
How do we do this?
Role Based: Licensed, Unlicensed Personnel13

14. 14
Role Based
Training Plans
ACRP, The Monitor, June 2008
Customization:
Procedures, JD,
SOP, SOE
(i.e., IATA/DOT, Privacy Laws trg)

15. 15
Wool, ACRP, The Monitor, Feb 2008

16. This approach is verified by
a UK Regulatory Authority -
MHRA
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17. 17
Martin, J., What the MHRA is looking for with competence verification
26 September 2013

18. 18
Martin, J., What the MHRA is looking for with competence verification
26 September 2013

19. Gold Award, Scholarly/Technical/Scientific Journal category in Association TRENDS’
2011 All-Media Contest19

20. Performance
Management
“Equip our Research Teams”
20
“Competent”
“Qualified”
As we venture forward….

21. SMART REPRODUCIBLE
SIMPLE
ACHIEVABLE
LOW TECH GLOBAL
QUALITY
21

22. 22

23. Thank You!
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24. For additional information
Liz Wool
lizwool@qd-qts.com
615-732-6035
www.qd-qts.com
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25. References
• Sonstein, S. et. al., Moving from Compliance to
Competence: A Harmonized Core Competency
Framework for the Clinical Research Professional,
Clinical Researcher, June, 2014
• Speicher, L., et. al, The Critical Need for Academic
Health Centers to Assess the Training, Support, and
Career Development Requirements of Clinical Research
Coordinators: Recommendations from the Clinical and
Translational Science Award Research Coordinator
Taskforce, CTS Journal, 2012, Vol 5, Issue 6
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26. References
• Martin, J., What the MHRA is looking for with
competence verification, 26 September 2013
• MHRA Good Clinical Practice Guide, TSO Press, 2012
• Wool L., Good Training Practice 101: A Primer for
Employee Training Plans, The Monitor, June 2008
• Wool, L., Let’s Focus on the Learner, Education and
Training in the 21st Century, Pardigm Shift to
Performance, The Monitor, February, 2011
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