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 sub-investigators, do we need to complete a 1572 for certain projects, etc. This course will review the new 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
- Investigators
- Sponsor/CROs
- CRAs
- CRCs
Sandra SAM Sather, MS, BSN, CCRA, CCRC
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1.5 hours; 2:30 - 4:00 p.m. Eastern
August 5, 2010
$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, 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#: 778-000-08-017-L04-P. Released: 10/08.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.