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!
Financial Disclosure: New FDA Draft Guidance for Clinical Investigator Reporting
Upcoming Courses
The requirements outlined in the federal regulations governing the disclosure of financial interests by Clinical Investigators permit sponsors and the FDA to assess the potential for bias in research by review of specific information. The integrity of data obtained from clinical research studies depends in large part on the ability to ensure that the data is free from bias or conflict of interest. Federal regulations require not only disclosure of this information, but development and implementation of plans to mitigate and manage any perceived or real conflict. This web seminar will focus on clinical research professionals’ responsibilities for disclosing, reporting, and managing potential conflicts that may impact the outcome of the study and the FDA’s review. Discussion will include review of sponsors’ due diligence requirements, regulatory authorities’ refined focus on financial information in clinical research, and the FDA’s actions and recommendations for ensuring requirements are met.
- Discuss the requirements and limitations of the Form FDA 3454
- Review reporting requirements in the “real world”
- Examine acceptable management/mitigation plans
- Define and discuss Significant Payments of Other Sorts (SPOOS)
- Evaluate requirements for clinical research conducted by foreign investigators
- Clinical Research Associates
- Clinical Investigators
- Project Managers
- Clinical Research Professionals involved in site and IRB assessment and/or selection
- Professionals from Academia involved in the oversight, documentation, and conduct of clinical research
- IRB Members, IRB Professionals, and Institutional Officials involved in oversight of clinical research
- Conflict of Interest Officers and Committee Members
- GCP-Focused Regulatory Affairs Professionals
Elizabeth Ronk Nelson, M.P.H.
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 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 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#: 0778-0000-11-062-L01-P. Released: 9/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
