Example
After adding the code lines, the code block will look like the following:
<bean parent="simpleMapping"/>
<property name="source" value="name" />
<property name="target" value="outputFileName" />
<property name="converter">
<bean parent="removeExtensionConverter"/>
</property>
</bean>
- Save and close the propertyMappings.xml file.
- Restart the Ennov InSight service.
Below is the list of Veeva DMS attributes that can be used to configure in the propertyMappings.xml file and to populate the same in Ennov InSight documents or auto-created leafs.
— id
— name__v
— title__v
— major_version_number__v
— minor_version_number__v
— type__v
— subtype__v
— classification__v
— binder__v
— document_number__v
— version_creation_date__v
— document_creation_date__v
— format__v
— filename__v
— status__v
— version_modified_date__v
— size__v
— product__v
— country__v
— description__v
— lifecycle__v
— locked__v
— locked_date__v
— export_filename__v
— md5checksum__v
Modify Leaf Elements
When you modify a leaf element, you need to know the type of leaf element and follow the procedure to modify according to the leaf element type.
There are two distinct types of leaf elements in Ennov InSight Publisher:
— A Standard leaf element is one that, upon eCTD publish or a publish of the electronic files, publishes to a unique PDF file. The published file has unique checksums and metadata.
— A Reference leaf element serves a different purpose. Often, when creating an eCTD, you may wish to submit to the agency an output leaf that is simply a reference or a pointer to either previously-submitted information or information that is present elsewhere in your assembly.
Changes you make to the attributes for an extended element in a previous sequence assembly do not affect the current sequence.
Before you modify leaf attributes, be sure the DMS browse window is closed. Content for one popup window sometimes appears in another popup window. If this occurs, close the pop-up windows and try the operation again.
Modify a Leaf Element
If you need to modify a reference leaf target location, first convert the leaf to a standard leaf, make the required edits, and then change it back to a reference leaf.
Note: You must have the appropriate security privileges to modify a leaf element.
To modify reference leaf attributes:
- On the assembly tree, select a leaf.
- Click Edit .
- On the Edit Leaf page, modify the attributes.
- Save
Leaf Attributes
The attribute descriptions help you to enter the appropriate attribute values while creating a leaf.
The table lists all the attributes that are available to you, while creating a leaf.
| Attribute | Description |
| Abbreviated Name | Short name for the leaf. |
| Actuate | Reserved eCTD attribute. |
| Application Version | The PDF application version for the software (for example, PDF Ver 1.2). |
| Change Modified Leaf | Enables you to select and add attributes based on another leaf. When you select an assembly to use, you can click the Search tab to find the assembly that you want. See Searching for an Assembly. |
| Clear Modified Leaf | Clears leaf attributes. |
| Comments | Text to save with the leaf. |
| Creation Date | The date the leaf was created. |
| Description | Text that describes the leaf. |
| Due Date | The leaf's completion date. |
|
Extension / Leaf Type |
Defines the type of leaf in the Assembly. |
| Font Library | Commercial font or font set used to create the file. |
| Keywords | Words you can use to search for a leaf. |
| Attribute | Description |
| Language | The primary language that will be used for your electronic eCTD; can be a variable or text. |
| Leaf ID | Unique number that identifies the leaf; you cannot change this value. |
| Leaf Status | Leaf status for the specific leaf. The values available for selection are all active leaf statuses from Data Administration, the default status is Planned. |
| Leaf Type | Type of leaf, you cannot change this value. |
| Modified File | Name of changed file. |
| Modified Leaf | Name of changed leaf. |
| Modified Leaf Sequence | Name of changed leaf sequence. |
| Name | Name of the leaf. |
| Number | Number that helps you identify the leaf. |
| Operation | Action used to create this leaf (append, delete, replace, new). |
| Output File |
Relative path and/or the file name of the published output for the leaf. — The value you enter cannot exceed 500 characters. — Avoid extra periods in the file name, such as output.file.doc, as this can result in an invalid file name in a DMS. |
| Note: For a reference leaf, this attribute is presented as a read-only field. | |
| Role | Indicates the regulatory role. |
| Show | Action used to show the leaf (embed, new, none or other). |
| Title | The title for the electronic eCTD. |
| Use Native File |
Determines whether to use source files or renditions for publishing. — To include both the native SPL XML and a PDF rendition, create a second leaf, assign the same document and choose No for Use Native File. — Do not assign a publishing effect (special sheet, TOC) or more than one document to a leaf when Use Native File is set to Yes. During publication, the publishing effect or document will not be added to the leaf, and no error message will be generated to indicate this. |
| Attribute | Description |
| Version | To comply with Appendix 6 of the ICH eCTD Specification, this attribute is used to indicate the internal version number or version identification for the file. However, for leaf elements pointing to STF files, this attribute is used to identify the version of the STF specification against which they are constructed, for example, STF Version 2.2 |
Duplicate a Leaf
You can create a new leaf by duplicating an existing leaf.
Note: You must have the appropriate security privileges to duplicate a leaf.
To duplicate a leaf:
- Right-click the leaf you want to duplicate and choose
Duplicate.
A new leaf appears below the duplicated leaf and the Edit Leaf page appears.
- Enter attributes for the leaf.
- Save
The leaf status of the duplicated leaf is set to the default Leaf Status value configured in Data Administration. You can change the Leaf Status on the duplicated leaf, as needed.
Convert a Leaf to a Reference Leaf
For submission to an agency, output leafs that are references or pointers to previously-submitted information or to information that is present elsewhere in your assembly must be converted to reference leafs.
To convert a leaf to a reference leaf:
- On the assembly tree, navigate to a leaf.
- Right-click on the leaf and click Convert to Reference Leaf.
A message prompts you to confirm that you want to delete any children that the leaf element has and convert the leaf.
- Click OK.
- On the next page, find the tab that displays the assembly that
has the leaf that you want to reference, and select that assembly.
If you want to search for an assembly, click Search.
- Expand the assembly, and select a leaf.
- Click OK.
Note: A reference leaf that points to an empty leaf will cause Prepare to Publish to fail.
The leaf appears in the assembly tree as a reference leaf with a reference leaf icon.
Note: The Leaf Status attribute is not presented on the attributes page of a reference leaf.
Convert a Reference Leaf to a Standard Leaf
To modify the target location of a reference leaf, you must convert a reference leaf to standard (default) leaf. After the target location has been changed, you can then convert it back to a reference leaf.
To convert a reference leaf to a standard leaf:
- On the assembly tree, right-click the reference leaf you want to convert and select Convert to Default Leaf. The reference leaf changes to a default leaf.
- When selecting the referenced leaf, Ennov InSight displays the current working assembly first, allowing you to choose a current leaf from the active assembly.
The leaf status of the converted leaf is set to the default Leaf Status value configured in Data Administration. You can change the Leaf Status on the converted leaf, as needed.
Deleted Leafs
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 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.
— 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.
Delete a Leaf
You can delete a leaf from an assembly tree if it is not required to be published and submitted to the regulatory agency.
Note:
— You must have the appropriate security privileges to delete leaf elements.
— If a volume break resides on the leaf you are deleting, you should move the volume break to the closest folder. Volume breaks that reside on a deleted leaf will not be published.
To delete a leaf:
- Right-click the leaf you want to delete and choose Delete. A message prompts you to confirm the deletion.
- Click OK.
The leaf and its contents are deleted.
Reorder Leafs
You can create leafs and assign documents to them as the documents become available and later you can reorder leafs in folders alphanumerically.
Reordering leafs can be useful, for example, with an assembly structure for literature references and study reports. Such a structure can contain hundreds of leafs.
You can reorder leafs only if they are in an unlocked assembly and folder or in an assembly and folder locked by using the eCTD lock. You cannot reorder leafs in an assembly or folder locked by using the standard lock.
