Updated August 20, 2025
- FDA's Transition from QSR to QMSR
- ClinicalTrials.gov Modernized Website
- Office Hours
- FDA Final Guidance on Informed Consent
- Single Sign-On (SSO) Requirement for CITI Training
- Recent FDA Guidance
FDA's Transition from QSR to QMSR
The Food and Drug Administration (FDA) is transitioning from the Quality System Regulations (QSR) to Quality Management System Regulations (QMSR) and the changes will be effective on February 2nd, 2026. The regulations will still fall under the same part within the code of regulations (21 CFR 820). The new QMSR will incorporate ISO 13485 and clause 3 of ISO 9000. Additionally, multiple other FDA regulations will be updated to reflect the changes from QSR to QMSR. More information about the proposed changes can be found on the following websites:
- Quality Management System Regulation: Final Rule
- Federal Register: Quality System Regulation Amendments
ClinicalTrials.gov Modernized Website
The ClinicalTrials.gov Protocol Registration and Results System (PRS) site is undergoing a modernization effort, and the modernized site will be the default site when users log in on Wednesday, August 28th.
What is not changing?
- There is no change to the ClinicalTrials.gov regulations or related policies. The same information is required to be submitted within the same time frames according to the regulations, NIH policy, and Georgia Tech's policy.
- Your log-in information will remain the same.
Office Hours
The Office of Regulatory Affairs and Clinical Trials holds virtual office hours on Wednesdays from 1:00 to 2:00. Please use the following link join for a one on one discussion.
Join Office Hours (Wednesdays 1:00 - 2:00)
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.
Single Sign-On (SSO) Requirement for CITI Training
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) continuously 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 Guidance on the FDA's website.