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Study Planning and Design

• Prepare or review sponsor-provided study design
• Conduct feasibility assessment to ensure research group has the relevant expertise, resources and patient base
• Contact a Grants and Contracts Officer at the Office of Sponsored Projects for preparation of a Clinical Trial Agreement (CTA) and budget proposal

Study Set Up

• Set up billing for proper cost allocations according to approved study budget
• Submit a protocol application to the University IRB for review and approval
• For investigator-initiated studies see, “Best Practices in Clinical Research Protocol Writing: Eight tips from an IRB member”
• Request an external IRB review and approval rather than a University IRB review

Special types of studies

• FDA research involving investigational drugs
• FDA expanded access and emergency use applications
• Investigational Device Research and Exempted Device Investigations
• Humanitarian Use Devices