|Study Tagging File Specification and Related Files|
|The Specification for Study Tagging Files (STF)|
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, deleted, append), the location of the document and information on the submission 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 business rules. This additional information is provided in the STF.
The STF is governed by an XML DTD. To ensure that the DTD has remained unchanged, use a tool to generate and compare the MD5 checksum of your copy with this MD5 checksum. The MD5 checksum of the STF DTD is: 0972c10a4dadf3df5d2f41b2026a4a5c
A stylesheet is also provided. To ensure that the stylesheet has remained unchanged, use a tool to generate and compare the MD5 checksum of your copy with this MD5 checksum. The MD5 checksum of the STF stylesheet is: 92BFEB4CB358A4AF786317A0DA2309C5.
For proper display of the STF stylesheet, the index.xml file must include the sequence number in the relative file path. See v3.2.2 Q&A document for additional information.
The stylesheet will highlight invalid tag values by utilizing the valid values list version 3.0. To ensure that the valid-values.xml file has remained unchanged, use a tool to generate and compare the MD5 checksum of your copy with this MD5 checksum. The MD5 checksum of the valid-values.xml file is: 301aaeb6b0fac8873a668fb4cbade517.
A new valid-values.xml file is now available as version 5.0. Consult regional regulatory authorities for guidance on implementation. The MD5 checksum of version 5.0 of the valid-values.xml file is: 76c2cdd2c20108d2b3e5d2c104720a83
Download and extract the Zip file to receive the specification, all related files and and sample data.
Last updated: August, 2018