Manage eCTD and eCTD 4.0 Templates

You can use the eCTD and eCTD 4.0 templates provided with Ennov InSight to streamline the process of creating eCTD and eCTD 4.0 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 and eCTD 4.0 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 Ennov InSight 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 and eCTD 4.0 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.

Ennov InSight Administration 7.3 Set Assembly Baselines

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 and ICH eCTD 4.0 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.

Maintain XML Definition Files

Manage all XML definition files (DTDs and schemas) in one central location in the repository to process XML instance documents stored.

Ennov provides you with specification updates as they are released and an analysis of how the changes impact your organization.

This information can include any of the following:

— Whether compliance to the new specification requires simply pointing to the latest XML definition file — Structural changes to assemblies based on the template

— Additional software changes

New XML definition files are provided when they are available. You can import these files into the repository and add them to the list of available definition files using the Assembly DTD/Schema Types function in Data Administration. You can then update assembly templates to use the latest XML definition files. The updated definition files are available for users who create assemblies using the updated templates.

The assembly templates provided do not point to their corresponding XML definition files.

Note: The XML definition files path can be changed in configuration. For any updates, please contact Ennov support.

Configure eCTD Templates

You can configure the eCTD templates provided with Ennov InSight for your product family and applications.

To configure eCTD templates for use, do the following for each template:

Choose a standard repository location for all eCTD, TOC, overlay, and cover page templates.
Choose a temporary repository location for publishing files.
Open the publishing settings for every template and do the following:
1. Specify the temporary publishing location.
2. Specify the template locations for all TOC types, cover pages, and all overlays (TOC, document, cover page) .
3. Click Apply on each settings page after confirming that all the default settings are completed.

Note: If you click away from the publishing settings without applying the settings you choose, the values you enter are not saved.

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.

eCTD Templates

Ennov InSight includes ICH-compliant eCTD and eCTD 4.0 templates with preconfigured folder types to capture the metadata for the specific headings in the eCTD that require additional information: drug substance, drug product, excipient, clinical indication, and regional administrative information.

Ennov InSight also includes a number of other assembly templates to enable the creation of reports or other electronic submission types.

These templates are current with the latest specifications and include the following:

— 510k Template (Sep 2019).xml

— 510k Template.xml

— ASEAN ACTD-NeeS.xml

— AU eCTD Module 1 v0.90.xml

— AU eCTD Module 1 v3.0.xml

— AU eCTD Module 1 v3.1.xml

— AU eCTD Module 1 v3.2.xml

— AU Module 1 CTD v2.1.xml

— AU Module 1 CTD-NeeS v2.0 2011.xml

— AU Module 1 NeeS v2.0.xml

— Canadian eCTD Module 1 v1.0.xml

— Canadian eCTD Module 1 v2.2.xml

— Canadian electronic CTA CTA-A 29-May-2013.xml — Canadian electronic CTA.xml

— CH eCTD Module 1 v1.0.1.xml

— CH eCTD Module 1 v1.1.xml

— CH eCTD Module 1 v1.2.xml

— CH eCTD Module 1 v1.3.xml

— CH eCTD Module 1 v1.4.xml

— eCTD ICH Module 2-5 v3.2.xml

— CN eCTD Module 1 v1.0.xml

— CN Nonclinical Study Report (SEND Dataset).xml

— CN Nonclinical Study Report.xml

— CN Clinical Study Report (VV5-0).xml

— CN eCTD ICH Module 2-5 v3.2.xml

— EAEU Template v1.0.xml

— EU CTA.xml

— EU eCTD Module 1 v1.0 - CP.xml

— EU eCTD Module 1 v1.0 - MRP-DCP.xml

— EU eCTD Module 1 v1.0 - NP.xml

— EU eCTD Module 1 v1.1 - CP.xml

— EU eCTD Module 1 v1.1 - MRP-DCP.xml

— EU eCTD Module 1 v1.1 - NP.xml

— EU eCTD Module 1 v1.2.1 - CP.xml

— EU eCTD Module 1 v1.2.1 - MRP-DCP.xml

— EU eCTD Module 1 v1.2.1 - NP.xml

— EU eCTD Module 1 v1.3 - CP.xml

— EU eCTD Module 1 v1.3 - MRP-DCP.xml

— EU eCTD Module 1 v1.3 - NP.xml

— EU eCTD Module 1 v1.4 - CP.xml

— EU eCTD Module 1 v1.4 - MRP-DCP.xml

— EU eCTD Module 1 v1.4 - NP.xml

— EU eCTD Module 1 v2.0 - CP.xml

— EU eCTD Module 1 v2.0 - MRP-DCP.xml

— EU eCTD Module 1 v2.0 - NP.xml

— EU eCTD Module 1 v3.0 - CP.xml

— EU eCTD Module 1 v3.0 - MRP-DCP.xml

— EU eCTD Module 1 v3.0 - NP.xml

— EU eCTD Module 1 v3.0.1 - CP.xml

— EU eCTD Module 1 v3.0.1 - MRP-DCP.xml

— EU eCTD Module 1 v3.0.1 - NP.xml

— EU eCTD Module 1 v3.0.3 - CP.xml

— EU eCTD Module 1 v3.0.3 - MRP-DCP.xml — EU eCTD Module 1 v3.0.3 - NP.xml — EU eCTD Module 1 v3.1 - CP.xml.

— EU eCTD Module 1 v3.1 - NP.xml.

— EU eCTD Module 1 v3.1 - MRP-DCP.xml.

— EU IMPD template.xml

— EU PMF Submission in eCTD.xml

— EU VNees - Immunological.xml

— EU VNees - Pharmaceutical.xml

— EU VNeeS v2.2 - Immunological.xml

— EU VNeeS v2.2 - MRL Maximum Residue Limits.xml — EU VNeeS v2.2 - Pharmaceutical.xml

— EU VNeeS v2.3 - Immunological.xml

— EU VNeeS v2.3 - MRL Maximum Residue Limits.xml

— EU VNeeS v2.3 - Pharmaceutical.xml

— GCC eCTD Module 1 v1.2 - GCC.xml

— GCC eCTD Module 1 v1.2 - NP.xml

— GCC eCTD Module 1 v1.5 - GCC.xml

— GCC eCTD Module 1 v1.5 - NP.xml

— HR eCTD Module 1 v1.4 - NP.xml

— ICH E3 Clinical Study Report (VV2-2).xml

— ICH E3 Clinical Study Report (VV3-0).xml

— ICH E3 Clinical Study Report (VV5-0).xml

— ICH eCTD 4.0 Module 2-5 v1.5.xml

— JP eCTD Module 1 v1.0.xml

— JP eCTD Module 2-5 v3.2.xml

— JAP eCTD 4.0 Module 1 v1.5.xml

— JO eCTD Module 1 v1.0.xml

— MD - IMDRF (HC) IVD Template.xml

— MD - IMDRF nIVD Template.xml

— Nonclinical Study Report (SEND Dataset).xml Nonclinical Study Report.xml

— PMA Template (Feb 2019).xml

— PMA Template.xml

— ROW CTD Module 1.xml

— Saudi Arabia CTD Module 1 v1.0.xml

— TH eCTD Module 1 v.0.92.xml

— TH eCTD Module 1 v.1.0.xml

— UA eCTD Module 1 v1.0.xml

— US eCTD Module 1 v2.01.xml

— US eCTD Module 1 v3.3.xml

— US eCTD 4.0 Module 1 v1.5.1.xml

— WHO eCTD Module 1 v1.0.xml

— ZA eCTD Module 1 v1.0.xml

— ZA eCTD Module 1 v2.1.xml

— ZA eCTD Module 1 v3.1.xml

The following files are included with the templates as samples for the publishing finishing options for overlays, Tables of Contents (TOC), and cover pages. Unicode (UC) templates for TOC, cover pages, and overlays are available (for A4 paper size).

— A4SampleTOCTemplate.docx

— SampleCoverPageTemplate.docx

— SampleOverlayTemplate.docx

— SampleTOCTemplate.docx

— UCSampleCoverPageTemplate.docx

— UCSampleOverlayTemplate.docx

— CNSampleTOCTemplate.docx

— JPSampleTOCTemplate.docx