Obtaining Regulatory Approval
Conducting research involving human subjects requires review and approval by the Institutional Review Board (IRB) and/or other review committees, including sometimes the Food & Drug Administration (FDA), as mandated by Federal regulations and OHSU policies and procedures. Investigators do not have to become regulatory experts to successfully fulfill compliance requirements necessary to get their study started. OCTRI has resources available to guide investigators through the process.
Study Start-Up Resources
- IRB Application Preparation and Submission
Including OHSU and Portland VA Medical Center IRB submissions
- Data Safety Monitoring Plans and Data Safety Monitoring Board Coordination
- Investigational New Drug and Investigational Device Exemption Applications
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