Manage eCTD Templates

You can use the eCTD templates provided with Calyx RIM to streamline the process of creating eCTD assemblies.

Separate templates are provided for each region's module 1. In addition, a common template for modules 2-5 is also provided. These templates are current with the latest ICH eCTD specification.

All the templates include elements and settings for both electronic and paper submissions. The folder types in the templates have been preconfigured to provide the metadata for the specific headings in the eCTD that require additional information: drug substance, drug product, excipients, clinical indication and regional administrative information. For example, the US, Canada and Japan regional module 1 templates include the entire administrative information and prescribing information folder/leaf /document structure required by regulatory authorities in those countries. A user can simply create an assembly from a template, remove the unnecessary folders/leafs and provide specific documents for the submission.

If a reference leaf in M1 is used to point outside of Module 1 to another module in the same sequence, the href-xlink path must be modified using  Calyx RIM Validator in the published output. ..\..\ must be added to the beginning of this path in the reference leaf, and the checksums must be recalculated.

In addition, you can modify the templates to contain default values for DMS attributes. If you have a well-organized Documentum Docbase with eCTD information included in document attributes, you can map these attributes at the publication level in the template. These attributes will be inherited in the assembly elements.

After a user creates an assembly from a template, he or she can easily modify specific folder and leaf attributes that are different from the default values. For attributes that are based on the ICH eCTD specification and for which default values are not configured in a template, users can choose values from preconfigured lists you set up in Data Administration.

Leaf elements are included in the templates at the lowest level, as defined by the ICH granularity document. While the DTDs allow for inclusion of leafs at higher levels in the assembly, the granularity document recommends where in the assembly to include documents. The templates conform with the granularity document. However, users are free to include leafs at higher levels in the assembly as required by your review division.