eCTD Module 5

eCTD Module 5

Module 5 Clinical Study Reports

The name of the folder for module 5 should be m5.

In cases where the application includes multiple therapeutic indications, the reports should be organized in a separate Section m535 for each indication. In such cases, if a clinical efficacy study is relevant to only one of the indications included in the application, it should be included in the appropriate section in m5 (eg m5\53-clin-stud-rep\535-rep-effic-safety-stud\anxiety\5351-stud-rep-contr). If a clinical efficacy study is relevant to multiple indications, the study report should be included in the most appropriate subsection of m535 and referenced as necessary in the equivalent section under the different indication.

In Module 2, a separate “Summary of Clinical Efficacy” module should be submitted for each indication, although closely related indications can be within a single document.
22. März 2012Permalink