Document Lifecycle and Status

Document Lifecycle and Status #

In eCTD publishing, document lifecycle management is a fundamental concept. Each document within a submission sequence has a lifecycle operation that describes its relationship to prior submissions — whether it is a new document being submitted for the first time, a replacement of a previously submitted document, an appendix to an existing document, or a deletion of a document from the dossier. DnXT Publisher provides a comprehensive lifecycle management system within the TOC Editor that tracks these operations and ensures eCTD compliance throughout the submission history.

Understanding Lifecycle Operations #

The eCTD specification defines four lifecycle operations that can be applied to documents within a submission sequence. Publisher manages these operations in the TOC Editor and records them in the eCTD backbone XML.

New #

The New lifecycle operation indicates that a document is being submitted for the first time at a particular TOC node. This is the default operation when you place a document in the initial submission (sequence 0000) or at a TOC node that has not had a document placed before in any prior sequence.

• When to use: First-time document placement at a TOC node in any submission.
• Effect: The document is added to the dossier at the specified node. There is no prior version to reference.
• eCTD XML: The leaf element has operation="new".

Append #

The Append lifecycle operation adds a new document alongside an existing document at the same TOC node. Unlike Replace, Append does not supersede the previous document — both the original and the appended document remain active. This is commonly used when supplementary information needs to be added to a section without removing the original content.

• When to use: Adding supplementary documents to a section that already has one or more documents, without removing the existing ones.
• Effect: The new document is added alongside the existing document(s). Health authority reviewers will see both.
• eCTD XML: The leaf element has operation="append".

Replace #

The Replace lifecycle operation supersedes a previously submitted document with a new version. The old document is marked as replaced in the cumulative view, and the new document takes its place. Replace is the most common lifecycle operation in amendment and supplement submissions.

• When to use: Submitting an updated version of a document that was previously filed. For example, updating a drug product specification after a manufacturing process change.
• Effect: The old document is marked as replaced. The new document becomes the current version at that TOC node.
• eCTD XML: The leaf element has operation="replace" with a reference to the replaced document.

Delete #

The Delete lifecycle operation removes a previously submitted document from the active dossier. The document is not physically removed from the submission history (it remains in the original sequence), but it is marked as deleted in the cumulative view, indicating that it should no longer be considered part of the dossier.

• When to use: Withdrawing a document from the dossier. For example, removing an outdated study report that has been superseded by a new study.
• Effect: The document is marked as deleted in the cumulative view. It remains visible in the submission history for audit trail purposes.
• eCTD XML: The leaf element has operation="delete" with a reference to the deleted document.

Setting Lifecycle Operations in the TOC Editor #

When you place a document at a TOC node in the TOC Editor, Publisher automatically determines the appropriate lifecycle operation based on context:

• If the node has never had a document placed in any previous submission, the operation defaults to New.
• If the node already has an active document from a prior submission, Publisher prompts you to select Append or Replace.

You can also manually set or change the lifecycle operation:

1. Select the TOC node in the left panel.
2. In the right panel Node Details view, locate the Lifecycle Operation field.
3. Click the dropdown and select the desired operation (New, Append, Replace, or Delete).
4. If you select Replace or Delete, you will be prompted to identify the specific prior document being replaced or deleted.
5. Complete the operation by filling in the required fields (title, filename, path for New/Append/Replace) and confirm.

Lifecycle Panel Details #

When you select a TOC node with a placed document, the right panel shows a Lifecycle Panel with the following fields:

Workflow Status #

Beyond lifecycle operations (which describe the eCTD document relationship), Publisher also tracks the Workflow Status of each submission. The workflow status represents where the submission is in your organization’s publishing pipeline:

You can change the workflow status using the Workflow Status Dropdown in the TOC Editor top menu bar. Status transitions may be restricted based on your role and your organization’s workflow rules.

Viewing Document History #

Publisher maintains a complete history of lifecycle operations for each TOC node. To view the history:

1. Select a TOC node in the TOC tree.
2. Switch to Cumulative view using the View radio buttons in the top menu bar.
3. The Node Details panel will show the complete history of documents placed at that node across all submissions, including the lifecycle operation for each entry.

This history is invaluable for understanding how a document has evolved across submissions and for auditing the dossier’s lifecycle trail.

Color-Coded TOC Icons #

As described in the TOC Editor guide, the TOC tree uses color-coded icons to indicate lifecycle status at a glance:

• Green — New document in the current submission.
• Orange — Document modified (replaced or appended) in the current submission.
• Red — Document marked for deletion in the current submission.
• Blue — Document carried forward from a prior submission (unchanged).
• Grey — Empty section with no document placed.

These visual indicators make it easy to scan the TOC tree and quickly identify which sections have been changed in the current submission.

Best Practices for Lifecycle Management #

• Always verify the lifecycle operation — After placing a document, confirm that the lifecycle operation is correct (New, Append, Replace, or Delete). An incorrect operation can cause validation errors or health authority rejection.
• Use Cumulative view for verification — Switch to Cumulative view regularly to verify that the overall dossier state looks correct.
• Be careful with Delete operations — Deleting a document from the dossier is a significant action. Make sure it is intentional and documented.
• Maintain consistent titles — When replacing a document, keep the title consistent with the original unless there is a specific reason to change it.
• Check cross-references — After replacing or deleting a document, check that hyperlinks from other documents still point to valid targets.

Frequently Asked Questions #

Can I change a lifecycle operation after placing a document? #

Yes, you can change the lifecycle operation in the Node Details panel as long as the submission has not been published. Simply select the new operation from the dropdown and update the necessary fields.

What happens to hyperlinks when I delete a document? #

Hyperlinks from other documents pointing to a deleted document will become broken. Publisher’s validation will flag these as errors, and you will need to update or remove the affected hyperlinks.

Can I replace a document that was appended? #

Yes. The Replace operation can target any active document at a TOC node, whether it was originally placed as New or Append.

Is there a limit to how many times I can replace a document? #

No. A document can be replaced in as many subsequent submissions as needed. Each replacement adds to the lifecycle history.

Related Articles #

• Submission Authoring with the TOC Editor — The workspace where lifecycle operations are performed.
• Adding and Managing Documents — Place documents before managing their lifecycle.
• Creating and Managing Hyperlinks — Manage links affected by lifecycle changes.
• Validating and Publishing — Validate lifecycle operations before publishing.