JANUARY 31, 2014

CTTI Project: Investigator Qualification

Meeting Background:

The goal of this meeting is to seek consensus on the key elements of GCP training and the frequency, format, and competency of training required to conduct clinical studies in the United States.

From left to right: Susan McHale, Bridget Foltz, Sheri Jacobsen, BSN, MA, Terri Hinkley, RN, BScN, MBA, CCRC, Jeffrey Cooper, MD, MMM, Barrett Katz, MD, MBA

Meeting Location:

Marriott North Bethesda, Bethesda, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

• Introduction by Pamela Tenaerts
• Meeting Goals and Opening Remarks by Susan Ellenberg

Session 1: The Current Landscape for GCP Training

• Perspectives on “GCP” and Clinical Research Training of Physicians by Jonathan Seltzer
• The CTTI GCP Training Project and Literature Review Findings by Susan McHale
• GCP Training: Purpose and Expectations by Stephanie Shapley

Session 2: Key Elements of GCP Training Programs

• Working Group Recommendations for the Key Elements of GCP Training by Tina Chuck

Session 3: Trainees and Differential Training by Job Function

• Differential Training by Job Function: ACRP Job Analysis Results by Morgean Hirt
• Site Perspective on Differential GCP Training by Christine Pierre

Session 4: Frequency, Formats, and Demonstration of Competency

• Moderated Panel Discussion Points by Gretchen Wild
• Moderated Panel Discussion Points by Bridget Foltz
• Moderated Panel Discussion Points by Barrett Katz
• Moderated Panel Discussion Points by Sheri Jacobsen

Session 5: Integrating GCP Principles In Clinical Research Conduct

• Integration of GCP Into Clinical Research—A Sponsor’s Perspective by Lorraine Waring
• Integration of GCP Into Clinical Research Training—An Academic Research Organization’s Perspective by Benetta Walker
• Update from the Joint Task Force for Clinical Trial Competency (JTF) by Rebecca Li