CTD Section 5.3.7 Report
Summary
Section Name:
Case Report Forms and Individual Patient Listings
Section Code:
5.3.7
Module Number:
5
Description:
This section should contain case report forms, which serve as a template document used by researchers to capture all relevant data for an individual subject on a given clinical protocol
Submission Timing
As early as initial IND application, revise as necessary
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources