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Jun 30 2011

Clinical Study Reports to STFs

GlobalSubmitWhen working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?”  To explain the importance of Study Tagging Files, we’ve asked Jason Rock, the Chief Technology Officer of GlobalSubmit, to author today’s guest post.

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.

Index.xml File Basics

The index.xml points to many files.  Each document is called a leaf.  A leaf will contain the file reference title, a path which points to the actual file in your file structure, and other values such as an append operation.  The leaf will appear in a specific area in the index.xml (e.g. M2-4), and this placement will control which section the file reference will inhabit inside a viewer.

EXAMPLE – (Note: information has been removed from the leaf for readability)

index.xml

In this example, a viewer will show a file reference with the title of “Nonclinical Overview” appearing in the ICH eCTD section “2.4 Nonclinical Overview” and this file will point to “nonclin-overview.pdf”.

Study Tagging Files Basics

With regards to Study Tagging Files XML, or STFs, the leaves in the index.xml are still added in the same way, so if you are working on a study for section “5.3.1.1 Bioavailability (BA) Study Reports” all of your documents will be added to this section in the same manner.  The one difference is that you now need one additional leaf which will be for your stf.xml file.  Now the STF is similar to the index.xml file in that it contains “leaves” which are actually “doc-content” sections.  It is these sections that will reference each document leaf you have added to the study section in your backbone.

EXAMPLE – (Note: the index.xml would contain a leaf in 5.3.1.1 for the stf.xml and one for the document with an ID of “int248”)

 

In this example, a viewer will show a study section for “5.3.1.1 Bioavailability (BA) Study Reports” with the Study ID of “GS 2010-111” the Study Title of “My example Bioavailability Study” and this study would contain a study sub-section “Study Report Body” with the file reference from the index.xml file inside of this subsection.

The following is an example of what a Reviewer would see with STFs.

Module 5

 

 

 

 

 

 

 

 

 

 

The following is what a Reviewer would see without STFs.

Module 5 - No STF

Conclusion

STFs are good because they organize study information into meaningful, standardized headings, which allows reviewers to quickly understand what has been submitted and what has not.  Can you imagine trying to review a study with all of the documents in one folder? It would be more than difficult to find the correct content.