Publishing_to_the_File

To publish a sequence, you must have saved all of your changes.

Choose Publish from the Manage menu or right-click the sequence level node in the Navigation pane.

Select Publish.

Publishing will then proceed in the background without the need for additional input from you. During publishing, the following functions will be performed:

Module 1 (eCTD Only)

• The regional backbone will be created and placed in the sequence number folder/m1/<region abbreviation> folder. It will be named /<region abbreviation>-regional.xml.

• For EU, any DTDs or style sheets referenced within XML documents in M1 will be added to the m1 util folder.

Modules 2-5

• The appropriate DTDs for the ICH backbone, regional backbone and (for US and CA) Study Tagging Files will be placed in the util/dtd folder under the sequence folder.

• The appropriate style sheet for the ICH backbone, regional backbone and (for US and CA) Study Tagging Files and valid-values.xml will be placed in the util/style folder under the sequence folder.

• For US eCTD sequences, a study tagging file will be created for each study in M4 and M5 and placed in the study folder. The same will be done for CA sequences unless studies were explicitly created using node extensions.

• For EU eCTD sequences, a node extension will be created for each study created using repeatable sections. Explicitly created node extensions will be retained.

• The XML backbone will be created and placed in the sequence number folder, named index.xml.

• A checksum file named index.txt for the XML backbone will be created and placed in the sequence number folder.