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.
Have you ever wondered whether as the Principal Investigator you might not know everything you should about how to oversee, manage, and conduct your study? Using International Conference on Harmonization Good Clinical Practice as the gold standard for the conduct of clinical research, this rigorous training for new and experienced clinical researchers who are interested in a refresher, will focus on providing information on:
- your responsibilities as investigator and/or investigator-sponsor,
- adhering to your 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.
Members of the BU/BMC research community who are new PIs (MDs, RNs, PhDs, etc.) who conduct clinical research, research fellows who plan to become PIs, and experienced PIs interested in a refresher.
2013 Spring Semester Date*
- Wednesday, June 5, 2013 9:00 AM to 12:30 PM
Location: Evans, Room E720
*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. Notification of opening of pre-registration will be sent by e-mail to the BU/BMC community ~2 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.
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 1-2 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.