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.
Regulatory Affairs, a sub-unit within ORIA, serves as a resource to the Georgia Tech research community by offering regulatory guidance in all aspects of clinical research (GxP) from preclinical (GLP) requirements to first-in-human studies (GCP) and beyond (GMP). Our goal is to provide the Georgia Tech research community with the training and guidance needed to navigate the complex regulatory pathways that accompany FDA regulated research from conception through commercialization. This goal will simplify the challenges and maximize potential of a high quality output to get novel innovative products to market faster by helping to contribute to the promotion and protection of public health.
IMPORTANT NOTICE: 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.