Best Practices for Studying Tagging Files

Study Tagging Files, according to the ICH definition are "an XML instance controlled by the ICH STF Document Type Definition (DTD)..." In order to efficiently process and review applications, information is needed on each document including the document title, subject matter, relationship to other documents, revision information, the location of the document and information on the submission that included the document. The eCTD backbone files do not contain enough information of the subject matter of study reports and their related files. This additional information is provided in the study tagging files (STFs) and is important because it provides information which makes it easier to identify documents and to make the submission easier to navigate through for reviewers.

Study Tagging Files are automatically created by your publishing tool, but of course a knowledgeable person needs to supply the information used to create them. Some best practices related to study tagging files are as follows:

• Each study must have a Study Tagging File, even if it only includes a single document. Don't make the mistake of thinking that the STF is unimportant for a single-document study—the information is still used to organize the document for viewing in the FDA's viewer, GlobalSubmit REVIEW. It's important to assign an accurate study number and meaningful, concise study title to each study, including nonclinical studies.
• Study metadata is also used to organized studies. Metadata depends on the type of study (such as Single-Dose Toxicology) and may include species, route of administration, duration, control type or no metadata at all. QC your metadata carefully, as eCTD contains no methodology for updating incorrect metadata (such as a wrong species) and work-arounds are cumbersome and confusing.

Each document in a study must be assigned a file tag identifying its contents. Make sure that you understand the file tags and their usage. The tag legacy-study-report should be used for all clinical and nonclinical reports for which a single file (or a few files not split by subject matter) is submitted.

For non-U.S. submissions (especially EU) make sure you understand whether your publishing tool will automatically remove the STF, and create guidelines for use of node extensions to organize studies in place of the STF. (Of course, if you publish your EU submissions first, the process occurs in reverse.)