The Principal Investigator Role: What Every New and Seasoned PI Needs to Know about the Conduct and Oversight of Clinical Research

Offered quarterly, this training is designed for those serving as Principal Investigators and will specifically address a PI’s oversight responsibilities for the conduct and management of a research study. The training utilizes International Conference for Harmonisation standards on Good Clinical Practice (ICH-GCP) and the Joint Task Force for Clinical Trial Competency as the structure for topics discussed.

Quarterly Offerings – All sessions are scheduled for 8-11:30am

  • Generally the course is offered in March, June, September, and November
  • Training is one 3.5 hour session
  • Registration closes 48 hours prior to training start
  • Includes Pre and Post Training Quizzes to assess learning and provide appropriate Good Clinical Practice certification
  • This training is currently offered over Zoom and intended to provide direct interaction and learning. Video recordings will not be made available for those who cannot attend. No exceptions will be made.

REGISTER – May 17th, 2024 *Registration is closed*

Good Clinical Practice Certification Overview

  • Successful completion of this training fulfills the BMC/BU Medical Campus HRPP GCP training requirement for 3 years.
  • Successful completion towards GCP Certification is fulfilled by the following requirements. No exceptions will be made to these requirements.
    • Attendance of 80% of the session
    • Post-training quiz score of at least 70%

Target Audience

  • BU Medical Campus and BMC investigators only. Individuals from external organizations or institutions are unable to attend.
  • Current Principal Investigators
    • New to research
    • New to BMC or BU Medical Campus
    • Experienced investigators interested in a refresher
  • Those who are interested in becoming a Principal Investigator in the future including fellows
  • All are welcome from various educational and professional backgrounds including medical, dental, nursing, and public health
Educational Objectives
  • Describe the responsibilities and oversight requirements of a Principal Investigator and Investigator-Sponsors
  • Explain the purpose of IRB and criteria for IRB review
  • Identify strategies to ensure protocol and safety plan adherence
  • Develop best practices in consent and screening processes
  • Identify study documentation best practices that fulfill regulatory requirements and support high quality research
  • Perform monitoring, evaluation and reporting of adverse events and unanticipated problems

Questions about which training to take? Review a comparison between Fundamentals and PI Training.
Questions about any of the above information? Contact us!