In all US samples, sequences where a study report component is deleted include a element in the STF for that study that references the ID of the leaf being deleted contrary to the language in the STF v2.6.1 specification, page 13: 2. Deleting Files Cited by an Existing STF…”No STF file would be called for since the leaf element for the file would be flagged as deleted and is thus effectively removed from the current view of the leaf elements referenced by the STF in that eCTD element.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.