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

Summary:

The Principal Investigator (PI) holds ultimate responsibility for the design, conduct, and management of a research study which requires up-to-date skills and knowledge.  Using International Conference on Harmonization Good Clinical Practice as the gold standard for the conduct of human research studies, this rigorous training for new and experienced clinical researchers who are interested in a refresher, will focus on providing information on:

  • responsibilities of an investigator and/or investigator-sponsor,
  • adhering to the protocol and safety plan,
  • best practices in consent and screening processes,
  • why and how to best document your study,
  • monitoring, evaluation and reporting of adverse events and unanticipated problems, and
  • navigating the IRB and the INSPIR application.

This training will satisfy upcoming institutional policy requiring GCP training for those involved in the conduct of clinical trials.

Target Audience:

Members of the BUMC/BMC research community who are new PIs (MDs, RNs, PhDs, etc.) who conduct human research studies, faculty, research fellows, residents and students, who are or plan to become PIs. This training is also relevant for experienced PIs interested in a refresher.

2016-2017 Training Dates*

  • August 8, 2016 (Mon.), 8:30 a.m. – 12:30 p.m.
  • November 16, 2016 (Wed.), 8:30 a.m.-12:30 p.m.
  • January 19, 2017 (Thurs.), 8:30 a.m. – 12:30 p.m.
  • June 6, 2017 (Tues.), 8:30 a.m. – 12:30 p.m.

Location: To be announced

*Note that the above dates are subject to change; frequency of offerings will be based on interest.

Registration:

Online pre-registration is required and there is a $60 registration fee for each workshop participant. Notification of opening of pre-registration will be sent by e-mail to the BUMC/BMC community ~3 weeks before each session and be limited to the first 25 enrollees; others will be put on a wait-list to either join the current session if openings become available or for the next available training. Click here to register for the January 19, 2017, PI training.  Each participant’s registration includes:

  • A bound reference training materials,
  • An FDA/ICH Good Clinical Practice Reference Guide,
  • Study documentation tools,
  • A Certificate of Completion,
  • Breakfast and snacks.

Payment can be made by credit card only (Visa, MasterCard and Discover). There are no refunds for cancellations. The registration fee can be transferred to another participant or to a future training (this training is expected to be offered 3 times per year).

Educational Objectives:

At the end of the workshop, participants should be able to:

  • Describe your responsibilities as investigator and/or investigator-sponsor,
  • Discuss your study oversight requirements as PI,
  • Identify strategies to adhere to your protocol and safety plan,
  • Develop best practices in consent and screening processes,
  • Explain why and how to best document your study,
  • Perform monitoring, evaluation and reporting of adverse events and unanticipated problems, and
  • Manage navigating the IRB application and submission processes.