Updated: August 16, 2023
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FDA Final Guidance on Informed Consent
The FDA has released Final Guidance on Informed Consent for the consent process during clinical investigations involving FDA regulated products. This document details requirements and responsibilities for investigators, sponsors, and IRBs. Additionally, this document provides guidance, examples, and FAQs regarding multiple topics that are relevant to Georgia Tech clinical investigations. It is highly recommended to review this document when preparing your informed consent prior to submitting to the IRB for review and approval if your study is investigating an FDA regulated product.
New Single Sign-On (SSO) Requirement for CITI Training
Effective May 8th, 2023: To access the CITI training website, all users (both GT and non-GT) will need to use the GT Single Sign-On (SSO) process. GT users will need to use this link to access CITI. Non-GT users will have to use an existing GT affiliation in CITI or will have to request a GT guest account so they can obtain CITI access and affiliate with GT. To request a guest account, please go to the Responsible Conduct of Research website and click "Submit Request for Georgia Tech CITI Access."