Calyx RIM 7.0 Publishing

Use the Create Study Report Wizard

The Create Study Reports wizard enables you to add study report structures (folders and leaf elements) to an existing eCTD or CTD. You can run the wizard one or more times as you obtain information about the study reports to include in the assembly.

Note: The Create Study Reports wizard does not support EAEU submissions.
To create a study report:
  1. In the selected eCTD assembly, choose Wizards > Create Study Reports.
    The Create Study Reports wizard appears and the Select Subsections page lists the available report sub-sections.
  2. Select the sub-section options to include in your study report.
    • To use the default values specified in the template, select Default Study Report Values from Template.
    • To copy the TOCs and special sheets from the template, select Copy TOCs and Special Sheets.
    • Select the individual folders and subfolders for the eCTD.
    • To remove a section, select it.
    • For existing standalone, lifecycle or non-lifecycle sequence assemblies, any section folders that already exist in the assembly are not available.
    • Selecting a top-level section automatically includes all the subsections for that folder.
    Note: In the Create Study Reports wizard, if you click Back to return to the Select Sub-Sections page your checkbox selections are not retained.
  3. Click Next.
    The Enter Quantities page appears.
  4. Enter the study report quantities per subsection.
  5. Click Next.
    The Enter Properties page appears.
  6. To add study reports to Indication folders, select the Update the sub-folder structure for 5.3.5 Reports of Efficacy and Safety Studies option specific to the indication folder.
    The study reports are added to the selected Indication folders. If no Indication folders are selected, an error is shown.
  7. Enter the property values for the study report. These values are normally populated automatically based on the template.
    • A Study Name value is initially populated with the name of the section that it is in. You must change the name value to avoid having folders in the section with the same name as the section.
    • If you selected Default Values from Template, any changes you make to the metadata that would reflect a deviation from the metadata values in the template are ignored when you complete the wizard.
  8. Click Next.
    The Confirmation page appears, confirming the information has been saved permanently to the assembly.
  9. Click Next.
    The Summary page appears.
  10. Click Finish.