What’s in Module 2 of the CTD?
(Note: This post is part of a multi-part series on the CTD this fall)
Module 2 of the CTD contains summaries of information presented in detail in modules 3-5. It starts with a one-page introduction that covers the pharmacologic class, mode of action, and proposed clinical use. The remaining sections have a specific order:
- Table of Contents
- Introduction
- Quality Overall Summary
- Nonclinical Overview
- Clinical Overview
- Nonclinical Written and Tabulated Summaries
- Clinical Summaries
The organization of the Quality Summary is described in detail in the M4Q guidance. The Nonclinical Overview and Summaries are described in the M4S guidance. This makes sense if you think about the process of pharmaceutical development, as the bulk of the nonclinical data is focused on safety. It will be no surprise that the Clinical Overview and Summaries are described in the M4E guidance. These guidances are full of interesting facts, and I encourage readers to indulge their interest with a full reading. Look for the upcoming posts to find out how the internal structure of the CTD makes finding and cross-referencing information simpler.
Reach out to me if you want to know more or discuss your medical product development challenges.
https://calendly.com/katrinarogers
Text Copyright © 2019 Katrina Rogers
Follow the links below to read each part of the series.
Electronic Regulatory Submissions Part 1
Electronic Regulatory Submissions Part 2
Electronic Regulatory Submissions Part 3
Electronic Regulatory Submissions Part 4
Electronic Regulatory Submissions Part 5
Electronic Regulatory Submissions Part 6
Electronic Regulatory Submissions Part 7
Electronic Regulatory Submissions Part 9
Electronic Regulatory Submissions Part 10
Electronic Regulatory Submissions Part 11
Electronic Regulatory Submissions Part 12
Electronic Regulatory Submissions Part 13
Electronic Regulatory Submissions Part 14