Calyx RIM Administration

Module 2-5 Template - Recommended Configurations

It is best practice to configure the templates for Modules 2-5 to prevent errors.

Add relevant XML definition files in the publishing settings for the template. If your organization always creates STFs (Study Tagging Files) regardless of region, include the ICH (ich3-2) and the STF (stf2-2) files. If you create STFs for US submissions only, you can add the STF files to the full Module 2-5 template later.

Set default leaf and study report DMS mappings and values in the publication settings for the template. Setting study report values in the Module 2-5 template while also using the STF XML definition file triggers the creation of STFs during publishing. If you create STFs only for US submissions, setting default values in the Module 2-5 template does not create STFs automatically for other regions as long you do not specify the STF XML definition file for those regions.

Set the assembly output location with the appropriate DMS location and cabinet in the template. When a user creates an assembly using the template, the user does not have to navigate through the entire repository to get to the specific product.

For product-specific information that maps to DMS attributes, set default values in the template. These include the following:

  • 2.3.S Drug Substance (substance and manufacturer)
  • 2.3.P Drug Product (product name, manufacturer, dosage form)
  • 2.7.3 Summary of Clinical Efficacy (indication)
  • 3.2.S Drug Substance (substance and manufacturer)
  • 3.2.P Drug Product (product name, manufacturer, dosage form)
  • 3.2.P.4 Excipients (excipient name)
  • 3.2.A.1 Facilities and Equipment (manufacturer, substance, dosage form, and product name)
  • 3.2.A.2 Adventitious Agents (manufacturer, substance, dosage form, and product name)
  • 5.3.5 Reports of Efficacy and Safety Studies (indication)

For detailed information about creating and modifying templates, see the topics Assembly templates and Assemblies.