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

The Principal Investigator Role training is designed for those serving as Principal Investigators and will specifically address a PI’s oversight responsibilities for the conduct and management of research. 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.

Register for the PI Training

    Who Should Take This Training

    • BU Medical Campus, BMC, BMC Brighton, BMC South and Boston HealthNet Community Health Center 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

    What You Need to Know

    • The course is offered 2-3 times per year
    • Training is one 3.5 hour session
    • Registration closes 48 hours prior to training start
    • Successful completion towards GCP Certification is fulfilled by the following requirements. 
      • Attendance of 80% of the session
      • Post-training quiz score of at least 70%
    • Includes Pre and Post Training Quizzes to assess learning and provide appropriate Good Clinical Practice certification.
    • Successful completion of this training fulfills the BMC/BU Medical Campus HRPP GCP training requirement for 3 years.
    • 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
    Educational Objectives
    • Describe the responsibilities and oversight requirements of a Principal Investigator and Investigator-Sponsors
    • Describe regulations and Good Clinical Practice that govern research
    • Explain the purpose of IRB and criteria for IRB review
    • Identify strategies to ensure protocol and safety plan adherence
    • Identify best practices in consent and screening processes
    • Identify study documentation best practices that fulfill regulatory requirements and support high quality research
    • Describe the purpose of monitoring, evaluation and reporting of adverse events and unanticipated problems, and identify strategies to adhere to these requirements

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