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Hello Regulatory Open Forum!
We have a clinical study report with data listings beyond the eight standard E3 categories (16.2.1 - 16.2.8), and eCTD only has eight tags for listings.
We don't know how to tag these additional appendices included with the report (16.2.9 - 16.2.14) which range from "Physical Examination" to "Comments". There is also an appendices for 16.4 "Individual Subject Data Listings" which is not applicable, but still included as a separate appendices and therefore requires a tag.
Any insight or links to resources would be greatly appreciated.
Thank you!