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 caregional.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.