There was some disagreement among our team about where to place this document in the eCTD structure. The two competing ideas were:
- Since this is a response to an FDA Request for Information, place it in Module 1.11.2 Safety Information Amendment; or
- Since this is related to an open, active protocol, place it in Module 18.104.22.168 with the protocol.
I emailed the CDER eSubs team for the deciding vote. Here’s the response I received:
Submit in module 22.214.171.124 under the specific study and tagged as “legacy-clinical-study-report” or “study-report-body”.
The minutes and related documentation should be submitted in a single PDF document with a table of contents, bookmarks and links, instead of separate PDF documents. Please use clear and concise leaf titles so it indicates the content of the document to help reviewers quickly and easily differentiate from the actual study report body.
So, if you find yourself in a similar situation, place the Data Monitoring Committee charter in the same location as the protocol and tag it as a study report in the Study Tagging File.