PrincipaI Investigator Oversight

The Principal Investigator (PI) is the individual responsible and accountable for conducting the clinical trial. The PI assumes full responsibility for the treatment and evaluation of human subjects, and for the integrity of the research data and results.

To ensure the highest quality of clinical research, the UW CTO staff is committed to helping investigators obtain a thorough understanding of investigator responsibilities, such as proper informed consent procedures, eligibility criteria requirements, adverse event reporting, etc.

PIs and Research Coordinators need complete understanding of FDA regulations and guidelines for conduct and implementation of the study protocol, other Federal, State, and local regulations and policies, as well as certification requirements including IRB, Conflict of Interest Disclosure, Human Subject Protection and Good Clinical Practice certifications.

As Principal Investigator, you are committing to:

• Protecting the safety, rights, and well-being of human subjects
• Conducting the study in accordance with current protocol
• Personally conducting or supervising the investigation
• Reporting the adverse events in accordance with federal regulations
• Following federal regulations and requirements for obtaining informed consent
• Ensuring that the Federal IRB requirements are met
• Maintaining adequate and accurate records and making them available for audit
• Promptly reporting to the IRB any changes or risks to human subjects
• Complying with all other requirements and investigator obligations specified in the federal regulations