Project:

Investigator Qualification

overview icon Overview

Qualifying Investigators to Conduct Sponsored Clinical Trials

Good clinical practice (GCP) training has become the industry standard for meeting sponsors’ responsibility to ensure qualified investigators. However, little evidence has been collected to determine whether GCP provides the knowledge and skills necessary to support investigators and their delegates in conducting quality clinical trials.

Rather than accepting GCP training as the default solution for qualifying investigators, CTTI is working to gain a broader, evidence-based perspective that can inform the efficient and effective qualification of site investigators and their delegates for the quality conduct of clinical trials. This work builds on a literature review, expert interviews, and a survey to assess current GCP training, culminating in recommendations for streamlining GCP training practices. These recommendations, published in an article in Therapeutic Innovation & Regulatory Science, focus on four components of training: minimum essential elements, training frequency, training format, and evidence of completion. As part of the second phase of work examining GCP training more critically to improve current approaches to investigator qualification, CTTI recently hosted an expert meeting to review new evidence and further discuss efficient and effective methods for investigators and their delegates to become qualified to conduct clinical trials. This meeting set the foundation for forthcoming recommendations and resources that sponsors and investigators can implement to better prepare clinical investigators for the quality conduct of a clinical trial.

 

 

 

“CTTI’s GCP training recommendations provide another real world opportunity to improve efficiency in clinical trials.”

Christine Pierre, President, Society for Clinical Research Sites (SCRS)

in detail icon In Detail

Sponsors must select investigators who are qualified and trained experts to investigate a drug, biologic (21 CFR 312.50 and 312.53), or device (21 CFR 812.40 and 812.43) in a clinical trial. To meet this requirement, sponsors often require all investigators, regardless of their previous experience and training, to take GCP training and training for each individual protocol. This often results in investigators and their staff being required to take GCP training multiple times each year, each taking hours to complete, which uses resources and drives up trial costs. No standards exist for the format, frequency, or assessment of GCP training. In addition, little evidence has been collected to determine whether GCP training actually provides the knowledge and skills to equip investigators to conduct quality clinical trials.

  • GCP Training: Developing an Efficient System for Investigator Training related to Good Clinical Practice Principles (2013 - 2015)
  • Qualifying Investigators to Conduct Sponsored Clinical Trials (2016 - Ongoing)
  • Develop a framework that defines quality conduct of a clinical trial
  • Describe the impact GCP training has on the quality conduct of clinical trials
  • Identify gaps and redundancies in the current training of investigators in preparation for the conduct of clinical trials
  • Identify key learning objectives for training to qualify investigators for the quality conduct of clinical trials
  • Recommend best practices to better prepare clinical investigators for the quality conduct of clinical trials
  • Recommend best practices to facilitate a more efficient approach to GCP training (complete; see Recommendations on GCP Training for Investigators)

Investigators and their delegates will be qualified to conduct trials in an efficient manner without the burden of redundant or ineffective training. Research sponsors will experience increased efficiency in trial conduct by devoting resources only to preparatory activities that contribute to the quality of trial conduct.

 

  • Literature review
  • Expert interviews
  • Review of existing GCP training programs
  • Discussions with  other organizations who also study GCP training
  • Survey
  • Expert Meeting on GCP Training
  • Expert Meeting on Investigator Qualification

Results from the literature search indicate that the following topics are usually included in GCP training:

  • IRB/IEC oversight
  • Investigator responsibilities
  • Staff training and delegation of responsibilities
  • Protocol adherence
  • Data management
  • Informed consent
  • Vulnerable populations
  • SAE and AE reporting
  • Monitoring

The literature did not contain information regarding the optimum frequency for GCP training and demonstration of competency. Most programs did include additional elements such as operational and regulatory compliance with GCP, OHRP regulations, and human-subject research ethics. Variations in the assessment of competency of GCP training were noted: frequency (ranged from 1 to 3 years), certification/testing, and different requirements based on program structure or job function.

Experts explored the 13 elements to GCP training outlined in the ICH E6 and commented that training components should be meaningful rather than only serving the function of fulfilling regulatory requirements. Attendees also agreed that streamlining GCP training would allow more time to be focused on protocol-specific training for investigators. Results from a job analysis survey conducted among individuals serving three types of clinical research functions (coordinators, monitors, and investigators) suggest tailoring GCP training and evaluating GCP knowledge as it pertains to each clinical function. The value of applied knowledge (i.e., giving trainees what they need to perform their job better) was stressed.

Results from the literature review were detailed on a poster presented at a DIA annual meeting. These results paired with comments and suggestions from the expert meeting informed CTTI’s official GCP Training Recommendations.

As part of the follow-on Investigator Qualification Project, CTTI convened an expert meeting in December 2017 to discuss further action that can be taken to inform the efficient and effective qualification of site investigators and their delegates. Meeting attendees discussed the need to shift the focus from individual investigators to the entire site team, as well as a need for mentorship, just-in-time training, and peer-to-peer networks to support site personnel in their roles. They also explored the possibility of more quality measures for qualification, an accreditation process, more patient-centric training, and better communication between and within sites.

As a next step, CTTI will work with stakeholders to develop recommendations and resources to improve the quality of trial conduct through optimized approaches to qualifying investigators and their delegates.

Project Team Members

Rolesort descending Name Affiliation Project
Executive Committee Champion Dalvir Gill TransCelerate Investigator Qualification
Project Manager Gerrit Hamre Clinical Trials Transformation Initiative GCP Training
Project Manager Jen Goldsack Clinical Trials Transformation Initiative Investigator Qualification
Social Science Lead Teresa Swezey Clinical Trials Transformation Initiative GCP Training & Investigator Qualification
Team Leader Susan Ellenberg University of Pennsylvania GCP Training
Team Leader Bridget Foltz Food and Drug Administration GCP Training
Team Leader Susan McHale AstraZeneca GCP Training
Team Leader Jonathan Seltzer ACI Clinical GCP Training
Team Leader Stephanie Shapley Food and Drug Administration GCP Training
Team Leader Sabrina Comic-Savic The Medicines Company Investigator Qualification
Team Leader Molly Flannery Food and Drug Administration Investigator Qualification
Team Leader Janette Panhuis Population Health Research Institute Investigator Qualification
Team Leader Veronica Todaro Parkinson’s Foundation Investigator Qualification
Team Leader Kristen Miller Food and Drug Administration Investigator Qualification
Team Leader Christine Pierre Society for Clinical Research Sites Investigator Qualification
Team Member Kate Haratonik Genentech - a member of the Roche Group Investigator Qualification
Team Member Patricia Hurley American Society of Clinical Oncology Investigator Qualification
Team Member Emily Lemons PMG Research, Inc Investigator Qualification
Team Member Rob Mentz Duke University Investigator Qualification
Team Member Jean Mulinde Food and Drug Administration Investigator Qualification
Team Member Louise Thurman IPS Research Investigator Qualification
Team Member James Kremidas Association of Clinical Research Professionals
Team Member Christine Hildebrand Amici Clinical Research
Team Member Jamie Arango Collaborative Institutional Training Initiative GCP Training
Team Member Tina Chuck Feinstein Institute for Medical Research GCP Training
Team Member Colleen Gorman Pfizer Inc GCP Training
Team Member Joanne Less Food and Drug Administration GCP Training
Team Member Kristen Miller Food and Drug Administration GCP Training
Team Member Gretchen Wild St Jude Medical GCP Training
Team Member David Ciavarella Becton Dickinson Investigator Qualification
Team Member Tina Chuck Northwell Health Investigator Qualification
Team Member Catherine Dillon Medical University of South Carolina Investigator Qualification
Team Member Bridget Foltz Food and Drug Administration Investigator Qualification
Team Member Kathy Goldstein Alexion Investigator Qualification