Study Tagging File Specification and Related Files

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.

This specification was created as an interim solution for study reports in November 2004.

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: 7af15705b92a21ac1a19527cfc504245.

The stylesheet will highlight invalid tag values by utilizing the valid values list. 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: 9b9b4641c0bfc0f0b3bc06a0e0654267.

Download and extract the Zip file to receive the specification, all related files and and sample data.