I don't know that there is a formal template, but the following is how I have successfully done it:
The annual reporting period for IND xxxxxx is February 5 – February 4. We request that the Annual Reporting period be synchronized with IND yyyyy, with an annual reporting period of February 24 – February 23. The proposed next DSUR for IND xxxxx will be submitted by April 24, 2016 and it will cover the time period from February 5, 2015 – February 23, 2016.
The key point is you need to choose which International Birthday date will be used and that the reporting time period for either IND cannot exceed 1 year.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 01-Nov-2019 09:43
From: Anonymous Member
Subject: DSUR request for Harmonization format
This message was posted by a user wishing to remain anonymous
Does anyone have a template for submitting a request for Harmonization for multiple INDs to be combined into a single DSUR?
We were asked to submit this by the agency.
(We are not combining a PSUR with a DSUR.)
Thanks for your help in advance!