As you may know, the Office of Research Integrity Assurance (ORIA) is no longer under the GTRC/GTARC organization, but is now included in the EVPR office. If you are sending email to associates in ORIA, and you are using the GTRI/GTRC mail system, you may find that your messages are not delivered. This is likely due to your mail client cache. If you experience bounced messages when sending to ORIA emails, please clear your auto-complete cache in your local Outlook client (e.g. https://its.unl.edu/emailhome/clear-e-mail-cache). After clearing your cache - resend the message. If you still receive a bounce back or if you do not hear back from ORIA, please contact us via phone or Teams to make sure your message was received.
Updated May 12, 2020
- FDA's Guidance for Clinical Trials During COVID-19 Pandemic
- FDA Emergency Use Authorizations
- Recent FDA Guidance
- New ORIA Office Location
The Food and Drug Administration (FDA) has released guidance on how clinical trials shall be conducted during the COVID-19 pandemic. Please CLICK HERE to read the guidance and see how this may impact your clinical trial.
The FDA can authorize the use of an unapproved medical products or the unapproved use of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives. These Emergency Use Authorizations (EUAs) have to be requested from the FDA and have strict guidelines. More information in regards to how to apply and guidance for EUAs can be found on the FDA’s website. Additionally, a list of current and terminated EUA's can also be found on the FDA's website. If you intend to apply for an EUA or utilize an existing EUA, please contact the Regulatory Affairs Office as soon as possible.
The Food and Drug Administration (FDA) continuosly releases guidance documents to inform the public of the Agency's current thinking on a particular subject. These guidance documents are not binding, but are considered to be best practice. Please see the current list of the Final and Draft Guidances on the FDA's website.
The administrative office for the Regulatory Affairs and Clinical Trials Office has moved from the Research Administration Building to the Dalney Street Building. Our new address is listed below: