Calyx RIM 7.0 Publishing

Study Tagging Files

Study Tagging Files (STF) help identify files associated with a study and are required for U.S. submissions. Some of this information is included in the eCTD backbone, however, the STF provides more information on the content of these documents.

The eCTD templates provide two assembly element types to capture STF information:
  • Study report folders capture the overall study information. This information is published as the study-information in the STF XML.
  • Study report leaf elements capture the subject matter to be used as the value for the file-tag name in the study-document portion of the STF XML.

Different folder and leaf types contain special attributes that are incorporated into the STF XML when you publish the submission. Each leaf in the templates has the Subject Matter value populated according to the STF specification. If you use DMS mapping to populate the eCTD, you can map STF-related attributes to repository attributes.

Sample study report structures are included in the ICH eCTD template for Module 4 (section 4.2.1.1) and Module 5 (section 5.3.1.1). These examples are preconfigured with the expected subject matter values. You can duplicate these folders in an assembly and remove any unnecessary components on a study-by-study basis. Alternatively, studies can be added using the Create Study Report Wizard. All sections in Module 4 are mapped to the Nonclinical Study Report. All sections in Module 5 are mapped to the ICH E3 Clinical Study Report template. You can configure the wizard to use different study report templates for each lowest-level section in Modules 4 and 5, if different structures are used for different study types.

Two special element types provided with Calyx RIM are set in the template for CRFs and Datasets to make them easier to use. They are Study Patient Information and Study Data.