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.
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
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
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
25
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
26