GlobalSubmit: Clinical Study Reports to STFs

What are STFs, how are STFs used, and why are STFs good?

Study Tagging Files, or STFs, organize study information into meaningful, standardized headings, not provided by the eCTD DTD, which allows reviewers to quickly understand what has been submitted and what has not. STFs provide consistency over the lifecycle of the regulatory application.

An STF should be provided with the submission of any file, or group of files belonging to a study in Modules 4 and 5. STFs are required by the United States, are not required in Europe and Canada, and are not allowed in Japan.

To understand STFs sufficiently you need to understand the index.xml.

For more information click here: GlobalSubmit STF