Proper completion of the Statement of Investigator has been greatly debated. Many stakeholders differ in opinions on what is accurate and adequate in completing this form. For example, who should be listed as subinvestigators, do we need to complete a 1572 for certain projects, and so forth. This web seminar will review the 2010 FDA information sheet and answer many of the questions about how to properly complete the form. The course will also discuss what is still not clear even after the guidance and how to get the answers.
- Review significant final guidance content
- Detail form completion clarifications for key debated sections
- Assess impact on current practices
- Review case studies of documented deficiencies of the form in warning letters and map the guidance to other FDA initiatives
- Site Research Managers and Coordinators
- Investigators
- Clinical Research Monitors
- Project and CRA Managers
- Clinical Research Directors
- Regulatory Affairs Professionals
- Sponsor/CROs
- CRAs
- CRCs
Karen L. Gilbert, B.S., C.C.R.A.
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2 hours; 12:00 - 2:00 p.m. Eastern
November 16, 2011
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.