Required Roles: Editor, Viewer
Required Permissions: eCTD Access
When an eCTD archive submission is imported into the Kivo eCTD Viewer, the viewer automatically runs a validation check on the sequence to confirm that all referenced content is present against the embedded XML files. If anything is missing or inconsistent, the viewer flags the submission with a validation error.
This article explains how the validation check works, what the most common error types mean, and the steps to resolve them so affected sequences can be viewed and worked with in Kivo.
Overview
The eCTD Viewer validation check runs every time a submission is imported. It compares the files physically present in the submission against what the embedded XML files declare should be present, and raises an error if those two views of the submission do not match.
Key concepts:
Validation runs on import. Every imported sequence is checked automatically, no manual step is required to trigger validation.
Some errors are non-blocking. In certain cases, users can still open and view the submission by selecting the Open icon even though an error flag is present.
Some errors are blocking. Other errors prevent users from opening and viewing the submission entirely until the underlying issue is corrected.
Errors can be inspected. Clicking the View Errors icon shows the full list of errors associated with each submission so the issue can be diagnosed and routed to the publisher.
Identifying and Viewing Errors
When a submission has been flagged, use the following workflow to identify the specific errors and determine whether the submission can still be opened.
Step 1 – Locate the Flagged Submission
From the eCTD Viewer, identify the imported submission that is displaying an error flag. A flagged submission will show an error indicator alongside the standard submission controls.
Step 2 – Check Whether the Submission Can Be Opened
Some errors are non-blocking. If the Open icon is available, you may open and view the submission while the underlying issue is being resolved. If the Open icon is disabled, the error is blocking and the submission cannot be opened until it is republished.
Step 3 – Review the Errors
Click the View Errors icon to open the list of all errors associated with the submission. Review each error to determine the root cause — typically a missing XML file, a missing content file, or a file located at an incorrect path.
Common Error Types
Most validation errors fall into one of the two categories below. Each has its own root cause and resolution path.
Error Type 1 – One or more XML files are missing. The submission is missing an XML file required for a specific sequence. For example, a missing XML file for sequence 0068 will prevent that sequence from being accessible in the eCTD Viewer.
Error Type 2 – One or more content files are missing. The XML in the submission references a content file by path, but the file cannot be found at that path. This typically occurs for one of three reasons:
The file is genuinely missing from the submission.
The file is present but has a different (incorrect) filename.
The file is present but located in a different folder than the XML path expects.
Notes, Permissions, and Important Behavior
Permissions: Users must be in the eCTD group with Editor permissions to import submissions and view or resolve validation errors.
Validation is authoritative. The viewer trusts what the embedded XML declares. Even if a file is physically present, a mismatched path or filename will still generate an error.
Errors are not edited inside Kivo. Validation errors are caused by issues in the submission itself and must be resolved by the publisher who produced the sequence, they cannot be corrected by editing files inside the viewer.
Non-blocking errors still require follow-up. Even when a submission can be opened despite an error, the underlying issue should still be resolved with the publisher to maintain submission integrity.
Resolving Errors and Reimporting
The resolution path depends on the error type, but the overall process is the same: work with the publisher to produce a corrected sequence, upload it as a new version, and reimport into the viewer.
Error Type 1 resolution: Request that the publisher republish the affected sequence(s) with the missing XML file(s) included.
Error Type 2 resolution: Request that the publisher republish the affected sequence(s) with the missing files added, filenames corrected, file locations updated, or XML files updated — whichever applies based on the specific error.
Upload the corrected sequence: Once the updated submission has been received from the publisher, upload it to the existing sequence as a new version.
Reimport into the eCTD Viewer: Import the new version into the eCTD Viewer. The validation check will run again automatically, and the submission should clear its error flag if the issues have been resolved.
Verify: Confirm the submission opens as expected and that the View Errors list is empty before closing out the issue.
Related Articles and Next Steps
Need help diagnosing an eCTD Viewer error or coordinating a republish with your publisher? Reach out via the messenger icon in the bottom-right of your screen or email [email protected].