A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Randomized Controlled Trials: Ethics, Consenting, Maintaining the Blind, and Protocol Adherence
Upcoming Courses
Currently, the FDA is making the case for Randomized Controlled Trials (RCTs) in evaluating Ebola therapies (NEJM Dec 18, 2014). The FDA is challenging industry and the medical community in the necessity of conducting scientifically valid trials and understanding the importance of the placebo effect. This web seminar will include an overview by a former FDA medical officer on the importance of learning how to “think like a regulator” especially during the consenting process, maintaining the blind, and protocol adherence. Case studies will be used to demonstrate the power of RCTs to achieve success. Bring your questions as you learn to see through the eyes of a regulator. Upon completion, learners will be able to better prepare investigators and sites for current study design challenges to fulfill both ethical and regulatory requirements.
- Describe the FDA’s latest approach to clinical investigations and additional challenges to auditing and monitoring RCT trials
- Determine how Congressional action might affect your studies
- Become a futurist thinker on the FDA
- Clinical Research Coordinators
- Clinical Research Associates
- Investigators
- Institutional Review Board/Ethic Committee Members
- Project Managers
- Directors
- Quality Assurance Professionals
- Regulatory Affairs Personnel
- Auditors
Jerri Barden Perkins, M.D.
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-15-078-L01-P. Released: 11/15.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
