The Principal Investigator Role: What Every New and Seasoned PI Needs to Know about the Conduct and Oversight of Clinical Research
Format and Registration
PI Training is a 3.5 hour training, from 8:00am to 11:30am. For now, and to limit COVID risk, the training will take place via Zoom-only.
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:
- which regulations and guidance pertain to and guide your research
- purpose of IRB and criteria for IRB review,
- responsibilities of an investigator and/or investigator-sponsor,
- adherence 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
This training will satisfy institutional policy requiring GCP training for those involved in the conduct of clinical trials for 3 years. Successful completion means attendance of the full training session and score of 75% or more on the post-quiz.
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Members of the BMC and BU Medical Campus 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.
Friday, December 10, 2021 (via Zoom)
Time: 8:00 a.m. – 11:30am
REGISTER for the December 10, 2021, PI training.
Except for special circumstances, we typically do not accept registrations from individuals from institutions other than BU and BMC. One of the reasons is that some of the content is specific to policies and procedures of BUMC and BMC. If you are from an outside institution and have interest please contact Mary-Tara Roth (firstname.lastname@example.org) to discuss before registering.
*PI Trainings can be delivered to individual departments upon request. Contact Mary-Tara Roth for more information about scheduling a departmental PI Training (email@example.com).
Online pre-registration is required. Registration will be limited to the first 25 enrollees and training sessions fill up quickly so register early. Click here to register.
At the end of the workshop, participants should be able to:
- Describe your responsibilities as investigator and/or investigator-sponsor,
- Explain the purpose of IRB and criteria for IRB review,
- 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