CTD Section 2.7.6 Report
Summary
Section Name:
Synopses of Individual Studies
Section Code:
2.7.6
Module Number:
2
Description:
This section should include 1 synopsis per clinical study, and a table entitled "Listing of Clinical Studies". Line items in the table should appear in the same order as study reports in Module 5 and synopses in this section. The sponsor may add tables and figures when they enhance understanding of the study
Submission Timing
As early as initial IND application (see note), completed by marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources