October 13 or October 15, 2015
10:00 AM Pacific time (1:00 PM Eastern time)
Phase 1 clinical trial design differs significantly from later phases. With readily distinguishable objectives and research involving healthy participants, unique ethical concerns arise. This webinar will explain some of the regulatory requirements that an IRB considers when reviewing Phase 1 research in healthy volunteers and will explore trial designs that optimize participant protection and study flexibility.
This webinar qualifies for 1 hour of CIP CE or 1 hour toward maintenance applications for ACRP certification.
The webinar will cover:
- Typical Phase I Healthy trial designs
- Risks and benefits to participants in Phase I Healthy trials
- Advertising/recruitment, informed consent, and compensation/reimbursement considerations in Phase I Healthy trials
- Methods to minimize risks to participants in Phase I Healthy trials
- Trends and case studies
David C. Babaian, JD, LLM, is a Regulatory Attorney for Quorum Review, where he provides legal counsel on regulatory issues and FDA requirements associated with research and development of investigational products. He earned a degree in health law, focusing in orphan product development, and is a member of the Health Law section of the Washington State Bar Association.
Continuing Education Credit:
Attendance at the Study Design and IRB Review of Phase I Healthy Clinical Trials webinar has been pre‐approved for 1.0 hour (or 1 point) of non-accredited CIP CE credit.
Attendance at the Study Design and IRB Review of Phase I Healthy Clinical Trials webinar has been pre‐approved for 1.0 contact hour of clinical research education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certification designations.
Both sessions (Tuesday and Thursday) cover the same material, so only 1 hour will be credited to you regardless of whether you attend both sessions. Certificates of Attendance will only be dispatched to the email addresses that are used to sign up for and attend the webinar. We are unable to provide certificates to anyone whose email address is not on the sign-up list or who does not attend during the announced times.