Investigator Qualification

Qualifying Investigators to Conduct Sponsored Clinical Trials

DECEMBER 13, 2017 TO DECEMBER 14, 2017

CTTI Project: Investigator Qualification

Meeting Objectives:

  • Report evidence gathered on:
    • Critical tasks associated with clinical investigators’ conduct of clinical trials.
    • Gaps and redundancies in training for preparing clinical investigators to conduct clinical trials.
    • Suggested knowledge and skills necessary for the quality conduct of clinical trials.
  • Evaluate proposed framework of characteristics within control of clinical investigator sites that define the quality conduct of a clinical trial.
  • Discuss how preparing clinical investigators for the quality conduct of a clinical trial could be optimized.
  • Identify the recommendations and tools that sponsors and investigators could implement to better prepare clinical investigators for the quality conduct of a clinical trial. Also, pinpoint the barriers—and solutions—to implementing these recommendations.

Meeting Location:

Hyatt Regency Bethesda 1 Bethesda Metro Center, Bethesda, MD 20814

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Welcome and Review of Aligned CTTI Work by Annemarie Forrest
  2. The CTTI Investigator Qualification Project and Meeting Goals by Jennifer Goldsack
  3. A Changing Ecosystem – A Brief Review of ICH GCP Renovations Planned and Currently Under Way by Theresa Mullin
  4. Proposed Framework of Characteristics that Define the Quality Conduct of a Clinical Trial by Janette Panhuis
  5. Evidence Gathering: Our Approach to Data Collection by Teri Swezey
  6. Critical Tasks that our Evidence Suggests Should be Well Executed to Drive the Quality Conduct of a Clinical Trial by David Ciavarella
  7. Perceived Risks to the Quality Conduct of Clinical Trials by Kate Haratonik
  8. Knowledge and Skills our Evidence Suggests may be Needed to Perform Critical Tasks and Mitigate Risks to Quality Trial Conduct by Catherine Dillion
  9. Evaluating Current Approaches to Preparing Investigators and Their Delegates by Patricia Hurley
  10. Building a Learning Ecosystem by Tina Chuck
  11. Case Study of an Investigator Mentoring Program by Emily Lemons
  12. Delivering Effective Training to Investigators and Their Delegates by Tina Chuck
  13. An Investigator's Reflections on Training by Christine Hildebrand
  14. FDA's Perspective on GCP Training by Bridget Foltz

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Expert Meeting on Good Clinical Practice (GCP) Training: Current Practices and Challenges

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:

Session 1: The Current Landscape for GCP Training

Session 2: Key Elements of GCP Training Programs

Session 3: Trainees and Differential Training by Job Function

Session 4: Frequency, Formats, and Demonstration of Competency

Session 5: Integrating GCP Principles In Clinical Research Conduct

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.