Calyx RIM 7.0 Publishing

eCTD Template Files

Calyx RIM includes ICH-compliant eCTD 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.

To ensure that you have the most current version of each listed template file on your system, refer to the New/Updated column in the table. This column contains information about the template status for each version in the Calyx RIM7.0 branch:
  • No - template was not updated
  • Yes - template was updated
  • New - template is new with this Calyx RIM version
  • Blank - template did not exist for the release
Template New/Updated
templates\510k Template (Sep 2019).xml Yes
\templates\510k template.xml No
\templates\A4SampleTOCTemplate.docx No
\templates\ASEAN ACTD-NeeS.xml No
\templates\AU eCTD Module 1 v0.90.xml No
\templates\AU eCTD Module 1 v3.0.xml No
\templates\AUS Module 1 CTD v2.1.xml No
\templates\AUS Module 1 CTD-NeeS v2.0 2011.xml No
\templates\AU Module 1 eCTD v3.1.xml No
\templates\AU Module 1 NeeS v2.0.xml No
\templates\Canadian eCTD Module 1 v1.0.xml No
\templates\Canadian eCTD Module 1 v2.2.xml No
\templates\Canadian electronic CTA CTA-A-29-May-2013.xml No
\templates\Canadian electronic CTA.xml No
\templates\CH eCTD Module 1 v1.0.1.xml No
\templates\CH eCTD Module 1 v1.1.xml No
\templates\CH eCTD Module 1 v1.2.xml No
\templates\CH eCTD Module 1 v1.3.xml No
\templates\CH eCTD Module 1 v1.4.xml No
\templates\CH eCTD Module 1 v1.5.xml No
\templates\CN eCTD Module 1 v1.0.xml No
\templates\CN eCTD ICH Module 2-5 v3.2.xml No
\templates\CN Clinical Study Report (VV5-0).xml No
\templates\CN Nonclinical Study Report (SEND Dataset).xml No
\templates\CN Nonclinical Study Report.xml No
\templates\eCTD ICH Module 2-5 v3.2.xml No
\templates\EAEU Template v1.0.xml No
\templates\EU CTA.xml No
\templates\EU eCTD Module 1 v1.0 - CP.xml No
\templates\EU eCTD Module 1 v1.0 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v1.0 - NP.xml No
\templates\EU eCTD Module 1 v1.1 - CP.xml No
\templates\EU eCTD Module 1 v1.1 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v1.1 - NP.xml No
\templates\EU eCTD Module 1 v1.2.1 - CP.xml No
\templates\EU eCTD Module 1 v1.2.1 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v1.2.1 - NP.xml No
\templates\EU eCTD Module 1 v1.3 - CP.xml No
\templates\EU eCTD Module 1 v1.3 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v1.3 - NP.xml No
\templates\EU eCTD Module 1 v1.4 - CP.xml No
\templates\EU eCTD Module 1 v1.4 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v1.4 - NP.xml No
\templates\EU eCTD Module 1 v2.0 - CP.xml No
\templates\EU eCTD Module 1 v2.0 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v2.0 - NP.xml No
\templates\EU eCTD Module 1 v3.0 - CP.xml No
\templates\EU eCTD Module 1 v3.0 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v3.0 - NP.xml No
\templates\EU eCTD Module 1 v3.0.1 - CP.xml No
\templates\EU eCTD Module 1 v3.0.1 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v3.0.1 - NP.xml No
\templates\EU eCTD Module 1 v3.0.3 - CP.xml No
\templates\EU eCTD Module 1 v3.0.3 - MRP-DCP.xml No
\templates\EU eCTD Module 1 v3.0.3 - NP.xml No
\templates\EU IMPD template.xml No
\templates\EU PMF Submission in eCTD.xml No
\templates\EU VNeeS - Immunological.xml No
\templates\EU VNeeS - Pharmaceutical.xml No
\templates\EU VNeeS v2.2 - Immunological.xml No
\templates\EU VNeeS v2.2 - MRL Maximum Residue Limits.xml No
\templates\EU VNeeS v2.2- Pharmaceutical.xml No
\templates\EU VNeeS v2.3 - Immunological.xml No
\templates\EU VNeeS v2.3 - MRL Maximum Residue Limits.xml No
\templates\EU VNeeS v2.3- Pharmaceutical.xml No
\templates\GCC eCTD Module 1 v1.2 - GCC.xml No
\templates\GCC eCTD Module 1 v1.2 - NP.xml No
\templates\GCC eCTD Module 1 v1.5 - GCC.xml No
\templates\GCC eCTD Module 1 v1.5 - NP.xml No
\templates\HR eCTD Module 1 v1.4 - NP.xml No
\templates\ICH E3 Clinical Study Report (VV2-2).xml No
\templates\ICH E3 Clinical Study Report (VV3-0).xml No
\templates\ICH E3 Clinical Study Report (VV5-0).xml No
\templates\JO eCTD Module 1 v1.0.xml No
\templates\JP eCTD Module 1 v1.0.xml No
\templates\JP eCTD Module 2-5 v3.2.xml No
\templates\MD - IMDRF (HC) IVD Template.xml Yes
\templates\MD - IMDRF nIVD Template.xml Yes
\templates\Nonclinical Study Report (SEND Dataset).xml No
\templates\Nonclinical Study Report.xml No
\templates\PMA Template (Feb 2019).xml Yes
\templates\PMA Template.xml No
\templates\ROW CTD Module 1.xml No
\templates\SampleCoverPageTemplate.docx No
\templates\SampleOverlayTemplate.docx No
\templates\SampleTOCTemplate.docx No
\templates\Saudi Arabia CTD Module 1 v1.0.xml No
\templates\TH eCTD Module 1 v0.92.xml No
\templates\TH eCTD Module 1 v1.0.xml No
\templates\UCSampleCoverPageTemplate.docx No
\templates\UCSampleOverlayTemplate.docx No
\templates\UCSampleTOCTemplate.docx No
\templates\US eCTD Module 1 v2.01.xml No
\templates\US eCTD Module 1 v3.3.xml No
\templates\ZA eCTD Module 1 v1.0.xml No
\templates\ZA eCTD Module 1 v2.1.xml No

Sample Templates

Calyx RIM includes additional assembly templates to enable the creation of reports or other electronic submission types. The following templates are 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
  • UCSampleTOCTemplate.docx