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!
Final FDA Guidance for Supervisory Responsibilities of Investigators: What Made it Through and How It Affects Sites and Sponsors
Upcoming Courses
This web seminar presents content and impact discussion of the now FINAL FDA Human Subject Protection Guidance Document posted in May 2007 and approved in October 2009. The guidance document addresses definitions of adequate supervision, appropriate oversight and delegations, adequate training, proper credentialing by principal investigators, and reasonable medical care and access to appropriate care for study subjects. How the guidance provides long awaited counseling on activities of the principal investigator regarding working with their study team and how the guidance impacts greatly on the role of the sponsor in qualifying and monitoring the research site will also be discussed.
- Recognize the history of the guidance draft and final releases
- Analyze the two major content areas of the guidance for the clarification of certain investigator responsibilities
- Examine implications on site and sponsor activities
- Explore case scenarios: Recent warning letters and more
- Clinical Research Investigators
- Clinical Research Coordinators
- Clinical Research Associates
- Clinical Research Managers
- Quality Assurance Personnel
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer biographies
$595
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 1-800-856-2556 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 mail ACPE statements within three weeks of program completion. ACPE#: 778-000-09-053-L04-P. Released: 1/10.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
