Leaf Elements

A leaf element is a collection of individual, published files submitted to a regulatory agency per the eCTD guidance. A leaf node is included under a folder in an assembly tree. A folder can contain other folders and leaf elements.

A leaf node appears in an assembly tree as a green leaf icon.

The following tabs are present on the Leaf Attributes page:

— PDF Properties

— Activities (displayed for the user with permissions on activities within the Entity Security section of Security Administration)

— Workflows (displayed for the user with permissions on activities within the Entity Security section of Security

Administration)

Add a Leaf

You can add a leaf element to an assembly under a folder.

Note: You must have the appropriate security privileges to add leaf elements to an assembly.

To add a leaf element to an assembly:

1. Right-click the assembly root or the element in the assembly where you want to add a leaf, and click Add Leaf. The leaf is added to the assembly tree with the name New Leaf.
2. On the Edit Leaf page, rename and enter attributes for the new leaf.
3. Save.
4. To undo modifications to the attributes, click Cancel. (The added leaf will remain, with the default attributes.)

Leaf Auto-Creation

When a document is assigned to an assembly, Ennov InSight automatically creates a leaf under an assembly section. For a leaf to be auto-created when assigning a document from a Document Management System (DMS) repository or a secure file system, the value of the assembly attribute Create Leaf Elements must be set to Yes. By default, the value of Create Leaf Elements is set to Yes. Some attributes of the auto-created leaf are populated with the source document attributes.

For more information, see Attribute Values for Auto-Created Leafs.

Attribute Values for Auto-Created Leafs

When a leaf is auto-created, the value of the leaf attributes such as the Name, Abbreviated Name, and Output File are taken from the attributes of a source document that is assigned.

A leaf gets the values of the Name, Abbreviated Name, and the Output File attributes from an assembly document.

Note: For a Veeva document, it is possible to use a file name with and without an extension using the nameWithExtension and name__v attributes respectively. The attribute owner_v cannot be used for customization. This is disabled to avoid extra API calls to Veeva Vault.

The following table lists the names of the attributes of a source document and their corresponding default names in different Document Management Systems (DMS) and the secure file system.

Define Document Attributes in the propertyMappings.xml File

Ennov InSight provides the ability to define auto-created leaf attributes as well as assembly document attributes that are taken from a source document in the propertyMappings.xml file.

By defining the Output File value, irrespective of whether a file with or without an extension is assigned, the extension for the native file remains unchanged. The extension of an Output File can be removed if the value of the attribute Use Native File is set to No. The same applies when a file is dragged within an assembly or imported from another assembly that results in leaf creation. Configuration can be made in the propertyMappings.xml file to enable removing of an extension from any leaf field. If such a configuration is applied and a leaf is updated, it is necessary to ensure the intended attribute value is taken. If the leaf attributes defined in the

propertyMappings.xml file fail to retrieve due to configuration discrepancies, the corresponding auto-created leaf attributes fields show blank values.

To define leaf attributes for an auto-created leaf:

1. Go to the <installation drive>:\InsightManager\server\all\conf\insight folder and open the propertyMappings.xml file in Notepad.
2. Locate the code section for the Document Management System or the secure file system that you use as repository for documents. Example of the code section for the secure file system: