Regulatory Knowledge and Support
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
- Consultation on Regulatory Requirements
- Data Safety Monitoring Plan Review and Consultation
- Investigational New Drug and Investigational Device Exemption Consultation
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