study tagging file
- Guideline or reference source
- ICHM2EWG The eCTD Backbone File Specification Study Tagging Files
- Definition
- In order to help identify all of the files associated with a study, information is needed on each document including the document title, subject matter (defined by the headings under which the documents are located in the table of contents), relationship to other documents (e.g., all documents for a specific study report are related to one another), revision information (i.e., new, replace, delete, append), the location of the document and information on the sequence that included the document. The eCTD backbone files (e.g., index.xml and us-regional.xml) include many of those information items. However, the eCTD backbone files do not contain enough information on the subject matter of several documents (e.g., study report documents) to support certain regulatory uses. This additional information is provided in the STF. For every submission to FDA that includes one or more files pertaining to a specific study, you should provide an STF.
- Abbreviation for
- STF
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