Previously, we looked at issues that arise within eCTD. Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in this article. The article looks at Module 1 specification issues and more.
We have outlined some additional guidance on eCTD validation errors that may help you in your journey with eCTD format.
Module 1 specification issues: Specific standards have been defined for the EU Module 1 Specification and when they are not followed validation errors can occur. For example, using an out-of-date module 1 specification will result in the following error codes listed in the EU eCTD validation criteria 7.1:
| 1.3 | ICH DTD | A currently acceptable version of the DTD is used (checksum matches the published value) |
| 4.3 | EU M1 leaf MOD file | The checksum for the eu-leaf.mod file used must match the published checksum for the eu-leaf.mod file associated with the DTD used for the sequence |
| 5.3 | EU M1 envelope MOD file | The checksum for the eu-envelope.mod file used must match the published checksum for the eu-envelope.mod file associated with the DTD used for the sequence |
| 6.3 | EU M1 stylesheet | The checksum for the style sheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence |
Steps To Overcoming eCTD Validation Issues
Validating a sequence using the old specification will cause a validation failure as the checksums will not match the current standard. If you validate your sequence and the following validation errors are listed relating to the checksum in the sequence not matching the standard, then you should follow the following suggestions to locate the issue.
- Go back to the validation software being used to revalidate the eCTD sequence and ensure it is up to date and validating to the current standard (i.e. EU eCTD validation criteria 7.1).
- Next, open the published sequence to confirm what DTD version was used. This information can be found in EU-regional xml file located in the module 1 folder. At the top of this file, a DTD version number can be seen above the EU envelope information. Take this DTD version number and compare it to the DTD version number outlined in the current EU module 1 specification. This document will confirm the current DTD that should be used. Besides, the current specification will outline the checksums for the EU-regional.dtd, eu-envelope.mod, eu-leaf.mod and eu-regional.xsl.
- If an out-of-date specification is being used, then your eCTD software may require an update to be in line with the current specifications.
eCTD Validation Error 1.4: ICH DTD
Explanation of Error Code
If this error occurs, then the eCTD software being used to create the current sequence requires an update to bring the DTD/specification to a level that is equal to or higher than the previous sequence submitted.
Solution
In short, this error code can appear for several reasons. For example, it can occur when dealing with multiple publishers operating using different versions of the eCTD software. Therefore, it is important to ensure when an update to DTD/Specification is planned, that the update is done on all eCTD software in use simultaneously. If this is not possible, then a strategic phased approach should be used to avoid sequences being published that used an older DTD/specification from the previous version published.
Do You Need Help with eCTD Issues?
We have a dedicated eCTD and electronic publishing team. They can assist you with any of the eCTD issues that you might be having. Contact us by using the form on our Contact Us page or by contacting us on 00353 52 61 76 706.
