In order to meet granularity requirements for sections such as 3.2.S, 3.2.P, etc., specific submission unit metadata must be added to Publish to build out the structure per combination.
With the section selected in the tree, press the + Add button in the Inventory Pane and select Context Group from the menu. Publish will prompt you to supply the properties for the selected section.
Note: Some fields are limited to values chosen from a list of controlled terms whose values are dictated by a regulatory authority and cannot be added or modified.
If an optional entry is not specified, there will be an “NA” appearing in the context group’s name in the tree.
Checking the Create new folder box will create a new folder in the output (with the name specified in the Output folder field). If unchecked, the results are kept in the context group folder itself.
After supplying all of the required properties for the new context group, click Save and the new group will be added to the tree.
Keyword usage for output folder paths
The Output folder field accepts any keywords (such as product, manufacturer, dosage form, etc.) as [[xxxx]] and the system will automatically populate the keyword values. Some examples include:
Single keyword: [[study id]] or [[Study ID]]
Multiple keywords: [[study id]] [[site id]]
Keywords separated by slash, for creating a folder path: [[study id]]/[[site id]]
Keywords in combination with text values: [[study id]]/test_folder/[[site id]]
Repeated keywords: [[study id]] [[study id]] or [[study id]]/[[study id]]
Examples of incorrect keyword usage, resulting in an “NA” in the folder naming include:
Incorrect keyword title: [[study_id]] or [[study-id]]
Non-existing keyword title: [[test]]
Incorrect keyword combination: [[study id, site id]]
Customizing default output paths for report context groups
When adding context groups to sections 4 and 5, some of the options listed in the Document Type menu have default output folder paths defined that are based on agency guidance, as listed below. To view and/or customize these paths, add the context group, then press Edit, and look for the Output folder field.
Document Type | Default Output Path |
data tabulation dataset legacy | [[sub root]]\[[module]]\datasets\[[Study ID]]\tabulations\legacy |
data tabulation data definition | [[sub root]]\[[module]]\datasets\[[Study ID]]\tabulations |
data listing dataset | [[sub root]]\[[module]]\datasets\[[Study ID]]\misc |
data tabulation dataset sdtm | [[sub root]]\[[module]]\datasets\[[Study ID]]\tabulations\sdtm |
data tabulation dataset send | [[sub root]]\[[module]]\datasets\[[Study ID]]\tabulations\send |
data listing data definition | [[sub root]]\[[module]]\datasets\[[Study ID]]\misc |
analysis dataset legacy | [[sub root]]\[[module]]\datasets\[[Study ID]]\analysis\legacy\datasets |
analysis program | [[sub root]]\[[module]]\datasets\[[Study ID]]\analysis\programs |
analysis data definition | [[sub root]]\[[module]]\datasets\[[Study ID]]\analysis |
analysis dataset adam | [[sub root]]\[[module]]\datasets\[[Study ID]]\analysis\adam\datasets |
subject profiles | [[sub root]]\[[module]]\datasets\[[Study ID]]\profiles |
iss | [[sub root]]\[[module]]\datasets\iss |
ise | [[sub root]]\[[module]]\datasets\ise@ |
Note: When adding a context group, selecting one of the document types listed in the table does not automatically display the corresponding default path in the dialog. You must first add the context group and then use Edit to see and customize the default path.
When editing a context group, changing the document type does not automatically
update the output path.