Regulatory Affairs: Important News and Updates

Updated August 16, 2023

Page Contents:

  1. FDA Final Guidance on Informed Consent
  2. New Single Sign-On (SSO) Requirement for CITI Training
  3. Recent FDA Guidance


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."


Recent FDA Guidance

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.