Human Studies Life Cycle
- Develop the Study Idea (for PI-initiated clinical studies )
- Activities Preparatory to Research
- Determine Feasibility
- Prepare the IRB Protocol
- Grant Applications
- Recruitment and informed consent documents
- Confidential Disclosure Agreement as needed
- Plan for IRB Review
- Choose the Appropriate IRB Application
- Identify Study Personnel
- Consider Special Study Requirements
The following reviews are frequently associated with the IRB process and should be completed prior to release of IRB review.
- Clinical Trials Registration
- Collaborating Institution or Consultant Agreements
- Confidentiality
- Export Control/Deemed Exports
- Human Stem Cell Research
- Human Studies Education Certification
- Institutional Biosafety Committee
- Intellectual Property
- Material Transfer Agreements
- Radiation Safety Committee
- Research Conflict of Interest
Grants and Contracts
PI-initiated Clinical Studies (Access via One Portal Only)
Industry-sponsored Clinical Studies
- Contract requirements
- Financial requirements
- CTC Contracts Guide
- Contact Clinical Trials Center
Government and Non-Profit
- Grants Guide
- Contracts Guide
- Contact Research Affairs - Financial Management
As PI, you are responsible for the submission process to the IRB, whether or not some aspects are delegated to a co-investigator or research coordinator. The following are typical steps in this process.