Study Data Folder

Use the Study Data folder type to organize datasets, which enables you to reset the output location for the folder's child leaf elements according to the FDA Study Data specification.

Datasets are organized in the <module>/datasets folder in the output rather than with the other components of the study report, so that you can manage them with the study report in the assembly.

The Dataset Type attribute controls the placement of the datasets in the <module>/datasets folder. Each child leaf element for this type of folder inherits the Subject Matter attribute.

For files that are not datasets, but other supportive files such as the Data Definition tables, the leaf elements included are set as Study Report Leaf elements. Their Subject Matter is populated to override the inheritance from the parent folder.

Ennov InSight 7.2 Publishing Study Data Folder