CTD Section 1.12.7 Report
Summary
Section Name:
Public disclosure statement for exception from informed consent for emergency research
Section Code:
1.12.7
Module Number:
1
Description:
Federal law requires that studies with an exception from informed consent make a public disclosure statement
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources