Project:

Investigator Qualification

overview icon Overview

Improving the Qualification of Investigators and their Delegates

Is Good Clinical Practice (GCP) training by itself the right approach for investigator qualification? Redundant training too often creates an unnecessary burden for site teams and limits the opportunity for more valuable, protocol-specific learning, and preparation. 

CTTI thinks there is a better approach. Building on many years of work on GCP and other investigator training, CTTI's most recent recommendations and resources recognize previous training and experience, identify gaps in knowledge and skills, and improve understanding of how to apply GCP principles to the conduct of clinical trials. 

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Discover Additional Deliverables Generated From This Project

Expert Meeting Materials

Summary of the Expert Meeting on Qualifying Investigators and their Delegates to Conduct Sponsored Clinical Trials

Recommendations

Good Clinical Practice (GCP) Training for Investigators

Publication

Good clinical practice training identifying key elements and strategies for increasing training efficiency. Therapeutic Innovation & Regulatory Science.

Expert Meeting Materials

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

Literature Review

Click here to view the literature review report on Good Clinical Practice (GCP) training for the conduct of clinical trials. This literature review of current practices in the implementation of GCP training was commissioned by the GCP Training Project Team in order to inform the project.

Press Release

Investigator Training Efficiencies Highlighted in New CTTI GCP Recommendations

Poster

Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

“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 - 2018)
  • 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.

CTTI then worked with experts and leaders across the clinical trials enterprise to develop recommendations and resources to improve the quality of trial conduct through optimized approaches to qualifying investigators and their delegates. These recommendations were released in November 2018.

Project Team Members

Rolesort descending Name Affiliation Project
Executive Committee Champion Dalvir Gill TransCelerate Investigator Qualification
Project Manager Annemarie Forrest 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 Molly Flannery Food and Drug Administration Investigator Qualification
Team Leader Christine Pierre Society for Clinical Research Sites Investigator Qualification
Team Leader Sabrina Comic-Savic The Medicines Company Investigator Qualification
Team Leader Suzanne Pattee 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 Jimmy Betchel Society for Clinical Research Sites 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 Natasha Phrsai Northwell Health
Team Member Christina Brennan Northwell Health
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 Regeneron Pharmaceuticals Investigator Qualification
Team Member Kate Haratonik Genentech - a member of the Roche Group Investigator Qualification