The Principal Investigator Role: What Every New and Seasoned PI Needs to Know about the Conduct and Oversight of Clinical Research
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 institutional policy requiring GCP training for those involved in the conduct of clinical trials for 3 years. 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.
- March 22, 2018 (Thurs), 8:30 a.m. – 12:30 p.m., location E-720
- June 15, 2018 (Fri), 8:30 a.m. – 12:30 p.m., location E-720
*Note that the above dates are subject to change; frequency of offerings will be based on interest.
Online pre-registration is required and there is a $60 registration fee for each workshop participant. Registration will 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 be register for the December 6, 2017, program. Each participant’s registration includes:
- Training slide presentations and materials,
- FDA/ICH Good Clinical Practice Reference Guide,
- Study documentation tools,
- 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).
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.