Fulfilling Compliance Requirements
Need to submit your study to the Institutional Review Board (IRB)? Trying to navigate the world of regulatory requirements?
Conducting research involving human subjects requires review and approval by the Institutional Review Board (IRB) and/or other review committees. Federal regulations and OHSU and Kaiser Permanente policies and procedures govern the compliance and regulatory processes.
Investigators do not have to become regulatory experts to successfully fulfill compliance requirements. OCTRI has consultants and experts available to guide investigators through the correct process.
Study Start-Up Resources
- Compliance Preparation and Submission
Including OHSU IRB, Kaiser Permanente IRB, Biosafety, Radiation, Knight Cancer Institute, and Portland’s VA Medical Center IRB
- ClinicalTrials.gov Registration
- Data Safety Monitoring Plan and Data Safety Monitoring Board Coordination
- FWA Assurance Assistance for Community Partners
- Drug Compliance, Coordination, & Reconciliation
- Investigational New Drug and Investigational Device Exemption Applications and Maintenance
Looking for a different phase of research?