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