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
Training: Human Subjects Division
Visit the UW Research Human Subjects Division’s (HSD) website for complete training information, education, and resources for conducting research at UW Medicine.
PRINCIPAL INVESTIGATOR CHECKLISTS
Checklist: All Studies
To successfully execute your clinical research study and ensure proper PI oversight:
- Train research staff on protocol
- Regularly meet with the study team
- Oversee study procedures
- Oversee informed consent process
- Oversee tasks delegated to co-investigators and research staff
- Promptly review and sign required documents, including lab tests and regulatory forms
- Oversee the recruitment process and adherence to inclusion/exclusion criteria
Checklist: Industry Sponsored Studies
Interventional or industry sponsored studies involving investigational drugs or devices may also require additional tasks including:
- Timely resolve data queries
- Review Investigator’s Brochure
- Review source data and case report forms (eCRFs)
- Adherence to Statement of Investigator-FDA Form 1572
Requirements are subject to changes and updates