Over time, you will need not only to submit new content but also to modify content previously submitted to a regulatory authority. The specifications provide operations for this purpose:
Replace: Used when a newer version of a document is being provided to replace an earlier version already submitted to a regulatory authority.
A document that has been replaced will have a red icon as a visual indication that the document is no longer current.
Append: Used when a document is being provided to add onto or expand upon a document already submitted to a regulatory authority.
• It can also be used to express a relationship between documents submitted in the same sequence.
• The document that is appending a previously submitted document will have a yellow icon as a visual indicator for the append relationship.
Delete: Used when a document is no longer relevant to the current status of an application, for example, a document related to a contract manufacturer who is no longer being used to manufacture the product.
• Both the previously submitted and the placeholder that is submitted for the deletion will show as a dark grey icon for a visual indicator.
• Both the previously submitted and the placeholder that is submitted for the deletion will show as a dark grey icon for a visual indicator.
Lifecycle relationships can be added, removed, or modified any time after a file reference is added. To view or modify lifecycle relationship for a file reference, select the document in the navigation tree and click the Relationships tab, where a user can remove relationships. By default, by adding a document to lifecycle, the leaf title is automatically inherited from the existing document upon addition, allowing for less work in manually modifying leaf titles.
The tab displays two sections showing all file references related to the selected file reference:
File References that I Replace, Append to, Link to, Delete, or Reactivate
File References that Replace, Append to, Link to, Delete, or Reactivate me
Operation | Source File Reference Conditions | Related File Reference Conditions |
|---|---|---|
Delete | Must not be in a Final state. | Not Applicable (no related file reference) |
Replace | Must not be in a Final state. | A single file reference must be selected (eCTD format only). |
Append | Must not be in a Final state. | A single file reference must be selected (eCTD format only). |
See the following sections for more information:
Lifecycling Documents through Multiple Sequences
Adding Relationships
Lifecycle Operators in Studies or Repeat Sections
The Delete Operator