How to Submit a DSUR to an eCTD IND

How to Submit a DSUR to an eCTD IND

It’s likely that you’re already preparing a Development Safety Update Report (DSUR) for submission to regulatory authorities outside the US.  If so, you will be relieved to know that FDA adopted the ICH E2F Guideline.  This means that FDA will accept the DSUR to meet an IND application’s Annual Report requirements.

There are 2 ways to submit a DSUR to an eCTD IND. Which method you use depends on which version of the Module 1 specification you’re currently using – the “Old” Module 1 specification or the “New” (v2.3) Module 1 specification.

Using the New (v2.3) Module 1 Specification

Among the changes in this version of the specification is a new section heading, 1.13.15, specifically for the DSUR. This simplifies the submission of the DSUR to an eCTD IND.

  • Place the DSUR as a single document in section 1.13.15 Development Safety Update Report (DSUR).
  • If information (other than the granular annual report information) is expected as a part of the DSUR, but the information has its own designated eCTD location, the information should be placed in its own designated eCTD location.
    • For example, the IB should be placed in section 1.14.4.1 Investigational Brochure. You should provide hyperlinks from the DSUR’s Appendix 1 and TOC rather than including it as an appendix in the DSUR.

Using the Old Module 1 Specification

An inquiry to FDA returned this advice on how to submit a DSUR to an eCTD IND using the old Module 1:

  • Place the DSUR as a single document in section 1.13.3 Summary of Safety Information.
  • State that the DSUR is being submitted in place of the IND Annual Report in the cover letter and provide a link to the document if possible.
  • If information (other than the granular annual report information) is expected as a part of the DSUR, but the information has its own designated eCTD location, the information should be placed in its own designated eCTD location.
    • For example, the IB should be placed in section 1.14.4.1 Investigational Brochure. You should provide hyperlinks from the DSUR’s Appendix 1 and TOC rather than including it as an appendix in the DSUR.

 

Editor's note: This post was originally published on 23 January 2012. I've updated the post to reflect FDA's current Module 1 specification (v2.3).