Modify Leaf Elements in the Working Assembly

Replacing a Leaf

• You can replace a leaf only once per sequence.
• You can replace directly from the assignment page by dragging one or more documents to an old leaf. This will automatically assign these documents to the leaf and change the leaf to an active Replace leaf.
• When you replace a leaf, the replaced leaf is hidden and the replacement leaf is displayed.
• The replacement leaf appears at the same location in the assembly tree as the leaf you replaced and you cannot move it.
• The replacement leaf has an operation of Replace.
• The replacement leaf has the default leaf status.
• When a reference leaf is replaced, it is converted back to a normal leaf. It must be manually converted again into a reference leaf, and it will need to be re-targeted to the new, replaced, version of the referenced document.
• The modified file for the replacement leaf references the replaced leaf. The modified file name is formatted as ../<replaced leaf sequence number>/index.xml#<letter><numeric identifierGUID>. For example, ../0001/index.xml#a9f5078464791677a9934ae330536bffa
• You cannot replace, append, withdraw, or delete the replacement leaf in the current sequence.
• You can revert the replacement leaf to undo the replacement. The leaf status is automatically reverted to the status that was set before the Replace operation.
• The replacement leaf assumes the content that was assigned to the replaced leaf. You can add, reorganize, or delete some or all of this content.
• The only content the replacement leaf has is the content you assign.
• According to the ICH eCTD specification, when you replace a leaf, the leaf in the index.xml is created automatically for each region's regional XML. For the us-regional.xml, eu-regional.xml, and ca-regional.xml, the operation on the leaf element in the index.xml is always New with no value for modified file. This is done per agency recommendation. For the jp-regional-index.xml, the operation on the leaf in the index.xml is New in the first sequence and Replace in subsequent sequences. The modified file automatically refers back to the previous sequence's regional leaf.
• If there are links that target the document assigned under the replaced leaf, they are re-targeted to point to the document assigned under the replacing leaf in the new sequence.  

Appending a Leaf

• The new leaf has an operation of Append.
• The new appendee leaf has default leaf status.
• The new appendee leaf is represented as the last child of the appended leaf.
• The new appendee leaf is created in the same folder as the appended leaf, and it appears as a child of the appended leaf.
• You can append a leaf more than once.
• The modified file for the new appendee leaf references the appended leaf. The modified file name is formatted as ../<appended leaf sequence number>/index.xml#<letter><numeric identifierGUID>. For example, ../0001/index.xml#a9f5078464791677a9934ae330536bffa   
• You cannot replace or delete the appended leaf in the current sequence. Calyx RIM does not allow a NEW leaf to be APPENDED in the same sequence. The appending document instead can be assigned below the first document under the NEW leaf, which will trigger Calyx RIM to perform a Leaf Roll-up of the two documents. This provides greater clarity to the reviewer and limits the use of Appends in the lifecycle.

Duplicating a Folder

When you duplicate a leaf element, an identical leaf is created in the new sequence. The attributes are the same, except for the leaf ID, modified file, and any assigned documents.

Deleting a leaf

When you delete (withdraw) a leaf that was submitted in an earlier sequence, you are indicating that the leaf should be removed from the submitted view when the current sequence assembly is added to lifecycle.

• The deleted leaf is hidden in the working view.
• A new leaf with an operation of Delete is displayed in the assembly tree.
• The new leaf has the default leaf status.
• The new leaf is positioned in the same location as the deleted leaf.
• The leaf and all its components are displayed with a line through them.
• Except for the leaf ID and operation, the new leaf has the same attributes as the deleted leaf.
• You cannot replace, append or delete the new leaf.
• You can revert the new leaf to undo the deletion. The leaf status is automatically reverted to the status that was set before the Delete operation.
• If the deleted leaf had content, the new leaf has the same content in the working view. In the sequence view however, the leaf is displayed with no content.
• The modified file for the new leaf references the deleted leaf. The modified file name is constructed as follows: Modified Leaf shows the leaf that is currently being modified by this leaf in the lifecycle. Modified Sequence shows the sequence that is currently being modified by this leaf in the lifecycle. Modified File Override is available to administrators only to allow an override of the modified leaf/sequence. This should only be used in certain situations because the change is not tracked in the lifecycle.
• Set Modified File is available in a working assembly to administrators, and in a standalone assembly to everyone. This allows the modified file to be manually set.
• Clear Modified File is available to administrators in a working assembly, and everyone in a standalone assembly. This allows the modified file to be manually cleared.
• You cannot change or move the new leaf, nor can you add elements to the new leaf.
• Deleted leaf elements are hidden in the submitted view after the current sequence assembly is added to lifecycle.

Reverting a Leaf Action

If you mistakenly perform a leaf operation, you can undo it by choosing the leaf for which you want to undo the operation, and then right-clicking the leaf and choosing Revert. To revert an appended leaf, choose the appended leaf, not the appendee leaf.