Course Description

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, 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.

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Learning Objectives

• 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

Who Should Attend

• Site Research Managers and Coordinators
• Investigators
• Clinical Research Monitors
• Project Managers
• Clinical Research Associate Managers
• Clinical Research Directors
• Regulatory Affairs Professionals
• Sponsors/CROs
• Clinical Research Associates
• Clinical Research Coordinators

Instructor

The course will be led by one of the following instructors:

Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.