Modify Publishing Settings Library Templates

You can access a Publishing Settings Library Template (PLT) from the Ennov InSight Home page and can modify it.

To modify publishing settings library templates

1. On the Ennov InSight Home page, click Publishing Templates.
2. In the Publishing Library Name list, choose a saved PLT.

   After opening the Publishing Settings Library Template, use the following procedures to modify the publishing settings.

3. On the selected Publishing Settings Library page, click the tabs on the Publishing Settings Library page to view, add, or modify the PLT settings.

— Publishing Settings

— Default Values

— Default Study Folder

— PDF Properties

— Volumes

— Cover Pages

— Tabs

— Slip Sheets

— TOCs

— Overlays

— Variables

— Link Profiles

Note: The procedures and attributes for each PLT tab are described in the corresponding topics and can be applied to both the Publishing Settings Library Templates (PLT) and the Assembly Specific Publishing Settings Library (APL).

4. On each tab: click Create or Edit, add or modify the settings, and Save.

Create Publishing Settings

In the selected Publishing Settings Library, you can create or modify the Publishing Settings to adjust printer output settings and XML definitions.

This procedure applies to both the Publishing Settings Library Template (PLT) and Assembly Specific Publishing Settings Library (APL).

1. On the Publishing Settings Library window, select Publishing Settings .
2. Click Create: .
3. On the Create Publishing Settings page, use the drop-down lists to choose the following required settings:

   — Printer

   — Paper Size and Type

   — Tab Paper Size and Type

   — Preview Location (Click Browse to locate and select the location.)

4. Complete the remaining fields as needed:

— XML Definitions

— Default Rendition Identifier

— Missing Rendition Identifier Handling

— TOC Destination Not Found Text

— Cross-Reference Destination Not Found Text

— Expand Bookmarks to Level

— PDF Version for Published Output

— Optimize Fonts in Paper Output

Note: Ennov InSight includes functionality to specify the rendition identifier to allow for a non-default Documentum or

Veeva rendition to be used for publishing jobs. This value can be set in Publishing Settings Library Templates (PLT) and

Assembly Specific Publishing Settings Libraries (APL). On the Publishing Settings tab, the option Default Rendition Identifier lists the values configured using the DMS Integration Rendition Identifier Values in Data Administration. See Maintaining a DMS Integration Value.

5. To save the new Publishing Settings, Save. To discard the changes, Cancel.

XML Definition File Version Updates

If the XML Definitions are set to a different XML definition than was previously used for the assembly, the system will initiate a renaming process when you save the file and the new XML Definition File is applied.

1. After the new XML Definition File is applied, refresh the assembly tree.

   Applying the new XML Definition File updates the assembly according to the new specification:

   — Values in extended attributes

   — Folder names

   — Leaf names. Abbreviated Name, Title, and Output File attributes are updated for leafs within a working assembly.

2. Check the following attributes of the leaf created as a result of any life cycle operation, and update if necessary:

— Abbreviated Name

— Title

— Output File

The Create eCTD Wizard can now be used for the Sequence. After the new XML definition file is applied, the changes within the current assembly cannot be rolled back. If it is necessary to roll back the changes, the working assembly must be deleted and recreated.

Publishing Settings Attributes

The attributes describe the details of the publishing settings used in a Publishing Settings Library Template (PLT). Required information is indicated by an asterisk (*).

XML Definition File Publishing Settings

The XML Definitions settings determine the specification that is used for publishing your eCTD submission.

The XML (eXtensible Mark-up Language) DTD (document type definition) files indicate which specification your eCTD submission should use for publishing. These files are generally associated with a specific assembly template, but submissions based on earlier versions of the specification may be updated to newer specifications by selecting the latest definition file in the Publishing Settings of the active working assembly. These files are placed in a repository that is accessible to Ennov InSight , and new ones may be added to this location as a result of a new agency or ICH (International Conference on Harmonisation) specification.

For eCTD, you typically select a regional DTD, the standard ICH DTD, and the STF (Study Tagging File) DTD. The STF DTD can be activated even if STFs are not being created, as this enables global reuse by allowing you to specify how Study folders should be processed in the XML at the module-level.

Only one DTD file for each output XML file can be assigned in the DTD settings. If more than one is assigned, an error may occur during publishing (fixpoint error). Multiple DTDs are assigned if multiple XML files are generated, for example: ICH index.xml, regional.xml, and possibly stf.xml.

Update eCTD XML Definition File Selections

When XML definition settings are updated, Ennov InSight prompts you to verify that you want to make the change. If you agree to the change, Ennov InSight automatically changes the folder and leaf types throughout the assembly to the proper versions.

In some cases, metadata is removed if it is no longer needed by the new specification XML definition. In most cases, Ennov InSight only adds new attributes or changes the labels or selections of existing attributes. If new sections are required by the new XML definition specification, it may be recommended to add these attributes separately using the Create eCTD wizard.

In every case it is a best practice to run the Create eCTD wizard immediately after updating the XML specifications.

For EU specifications, keep in mind the following:

— When you include the electronic application form in EU module 1, section 1.2, ensure the form-1-1 rules are active in the publication settings to ensure the DTD and stylesheet are copied to the appropriate location during publishing.

— If you are using v1.1 of the EU specifications, and submitting PIM information in section 1.3.1, you also need to ensure the pim-2-1 rules are active to ensure the supportive files are correctly output.

— When you are using the v1.2.1 specification or later, these rules should not be active since the PIM information is provided as a single .zip file.

eCTD Publishing Settings

Specifying the general electronic eCTD publishing settings enables the entire eCTD assembly to inherit leaf element and study folder attributes. These settings contribute to default values for leaf elements in the eCTD XML files, and the default properties for study tagging or other study XML files.

The eCTD publishing settings are applicable to both the Default Values and the Default Study Folder in the Publishing Settings Library Template (PLT) and the Assembly Specific Publishing Settings Library (APL).

Generally, these settings are used to either:

— Set up a global value for an XML attribute that generally will not change, for example: the font library.

— Inherit this information from attributes that are already stored in your document repository. An administrator must have already configured repository variables (in Data Administration) so Ennov InSight can find the metadata, and placed these variables in the attributes on the settings page.

Any attributes defined on a particular leaf use the assigned values. Ennov InSight inherits only values from these settings if the value has been left blank on the element itself.

Modify Default Publishing Values

In the selected Publishing Settings Library, you can modify the default publishing values.

This procedure applies to both the Publishing Settings Library Template (PLT) and Assembly Specific Publishing Settings Library (APL). To modify the default publishing values:

1. On the Publishing Settings Library window, select the Default Values tab.
2. Click the Edit icon.
3. On the Edit the Default Values page, enter your changes to the default values.
4. Click Save.

Default Publishing Values Attributes

Attributes description for default publishing values.

The attributes differ depending on the eCTD version, for the details of eCTD 4.0 attributes, see Publishing > Default Publishing Values Attributes eCTD 4.0 .

Default Study Folder

In the selected Publishing Settings Library, you can modify the Default Study Folder for the Publishing Library Template (PLT). The Default Study Folder tab is available only when an STF DTD definition is selected on the

Publishing Settings tab of the PLT.

This procedure applies to both the Publishing Settings Library Template (PLT) and Assembly Specific Publishing Settings Library (APL).

1. On the Publishing Settings Library window, select Default Study Folder.
2. Click Create .
3. Complete the fields as needed. There are no required fields.

   — Full Report Title

   — Report Number

   — Operation

   — Species

   — Route of Administration

   — Type of Control

   — Duration

   — Subject Matter

4. To save the new Default Study Folder, Save. To discard the changes, Cancel.

Default Study Folder Attributes

The Default Study Folder tab is available only when a study folder XML definition is selected on the Publishing Settings tab of the PLT. Values for Species, Route of Administration, Type of Control, Duration, and Subject Matter are controlled by the XML definition selected.

About PDF Properties

You can add PDF Property settings to the Publishing Settings Library Template (PLT) and to the Assembly Specific Publishing Settings Library (APL) to define the PDF properties of the electronic published output.

In addition to the PLT and APL PDF property settings, Ennov InSight enables you to create leaf-specific PDF property settings:

— While the APL and PLT PDF property settings are defined for the whole assembly, leaf PDF property settings are defined for an individual leaf element only.

— When importing or exporting an assembly, only APL PDF property settings are preserved. Any leaf-specific PDF property settings are automatically removed.

— Leaf PDF property settings are preserved in the duplicated leaf or folder.

— Adding or modifying leaf PDF property settings in the working assembly updates both working and publishing views.

— To use a specific property from the source document, set the PDF Property Source attribute to Use Source Document Property.

— If at least one PDF Property is defined, the submit.document.properties=true parameter in the insight.var is ignored.

Note: Due to the additional information that is processed when using PDF Properties, the time needed to complete publishing can be increased.

Leaf PDF properties are not available in:

— Approved, submitted, and sequence views.

— Publishing view of a locked assembly.

Add or Modify PDF Properties

PDF Properties are used to define the PDF properties of the electronic published output document.

In the selected Publishing Settings Library, you can add or modify the PDF Property settings. This procedure applies to both the Publishing Settings Library Template (PLT) and Assembly Specific Publishing Settings Library (APL). You must have sufficient security permissions to be able to create or modify a PDF Property setting.

1. On the Publishing Settings Library window, select PDF Properties.
2. Click the Create icon .

   To edit an existing PDF Property setting, click a named PDF Property in the list on PDF Properties.

3. On the Create PDF Property Settings page, complete the required fields, and the optional fields as needed. Required information is indicated by an asterisk (*).

   — Output PDF Property*

   — Configuration*

   — Value*

   — Separator

   Note: The set of attributes varies, depending on the value selected in the PDF Property Source field.

4. To save the new PDF Property Settings, Save.

Delete a PDF Property

You can delete a PDF Property Setting, as necessary. Use this procedure to delete a PDF Property Setting from the

Publishing Settings Library (PLT), Assembly Specific Publishing Settings Library (APL) or a Leaf element. You must have sufficient security permissions to be able to delete a PDF Property setting.

Note: This procedure is not applicable for deleting a PDF Property setting inherited from the APL for a specific Leaf element. In order to not apply the inherited PDF Property setting for a specific Leaf, you should set the PDF Property Source value to Do Not Populate by modifying the PDF Property setting from this Leaf element.

1. On the PDF Property Settings tab, select the PDF Property you want to delete.
2. On the PDF Property Settings view page, click Delete.
3. On the warning message that appears, click OK.

PDF Property Attributes

The attribute descriptions help you to enter the appropriate attribute values while creating a PDF Property setting for the Publishing Settings Library Template (PLT) or Assembly Specific Publishing Settings Library (APL).

Required information is indicated by an asterisk (*).

Volumize

Volumization is the process by which assembly content is divided into multiple volumes for the purpose of publishing paper volumes. You can define the settings for splitting the assembly into volumes using the volume settings.

Volumization settings include:

— The number of pages that make up the volume.

— The size of the page buffer, which indicates the number of pages under the specified volume pages that would still be considered as a valid volume size. — The total size of each volume.

— The buffer size of each volume, which indicates the number of MB under the specified volume total size that would still be considered as a valid volume size.

— Whether to automatically create volume TOCs for each volume.

— The name and numbering schema for each volume (specified by default as the variable $VOLNAME). — Whether volumes should be counted relative to the assembly or the major division (module).

Volume settings are included in a Publishing Settings Library by default. When creating a new Publishing Library Template (PLT), or when creating a new PLT based on an existing PLT, the Begin at Volume Number setting is set to 1.

You can start a volumization from the start of an assembly, a subset folder, or a section in the assembly. Volumization will end when either a locked volume is encountered or the end of the assembly is reached.

Volumization may take a significant amount of time to accomplish, so the recommended way to volumize is by using the Prepare to Publish process.

Positioning your cursor over a volume indicates the number of current pages, but in certain cases it may be necessary to refresh the volume page count. This can be done with either the volumes refresh option or the Prepare to Publish process.

During volumization, the assembly is not locked. You must wait for volumization to complete before attempting to select any elements.

Ennov InSight provides the ability to create volumes in an assembly based on an estimated output file size.

Because Volumize by Size can be a time-consuming process, Ennov recommends completing all assembly creation steps (including Prepare to Publish) prior to invoking this functionality. An assembly paper output location is required when using the Volumize by Size option. There is a limitation of assembly content size that can be processed at once, so it is recommended to use Volumize by Size option in a reasonable time periods. See Memory Limits for Windows and Windows Server Releases.

For Volumize by Size, using the No option causes Volumize by Page to be enforced when the right-click menu option Volumize is invoked in the assembly. Volumize by Page provides faster performance than Volumize by Size.

When the Volumize by Size option is set to Yes, all volumes will be deleted and recreated, including locked volumes.

Use the Volumes tab in the Publishing Settings Library to set or modify the following options:

— Volumize by Size

— Total Size (in MB)

— Buffer Size (in MB)

Note: 1MB = 1,048,576 bytes

Volumes also enable you to divide an assembly into logical sections that will be published to the paper output channel as separate files, one file for each volume.

If you choose to divide your assembly into paper volumes, you can create volumes in several ways: — Bulk volumization

— Insert manual volumes

— Insert and manipulate existing volumes

Volume settings must be defined in the Publishing Settings Library prior to inserting volumes.

Define or Modify Volume Settings

Use the Modify Publishing Settings command to modify volume attributes for your assembly.

1. In an assembly view, click Edit Publishing Settings Library to open the Publishing Settings.
2. Select Volumes.
3. On the Volumes tab, click Edit to specify the Volume attribute settings.
4. Save.

Volumes

In the selected Publishing Settings Library, you can modify the Volumes settings. This procedure applies to both the Publishing Settings Library Template (PLT) and Assembly Specific Publishing Settings Library (APL).

To modify the Volumes settings:

1. On the Publishing Settings Library window, select Volumes. The default Volumes settings appear.
2. Click Edit .
3. On the Edit Volume Settings page complete the required fields, and the optional fields as needed. Required information is indicated by an asterisk (*).

   — Volume File Naming Format *

   — Begin at Volume Number *

   — Total Sheets/Pages *

   — Total Sheets/Pages Buffer *

   — Volumize by Size

   — Total Size (in MB) *

   — Buffer Size (in MB) *

   — Volume Numbering

   — Automatically Create Volume Tables of Contents

4. Save. To discard the changes, Cancel.

Volume Attributes

You can use the attributes to describe the details of a volume. Required information is indicated by an asterisk (*).

Bulk Volumization

Bulk volumization enables you to divide assembly content into multiple volumes automatically.

Volume publishing settings identify how the assembly is divided into volumes including the default size and other characteristics of the volumes inserted during the bulk volumization process.

Content that has been rendered or has a planned page count, and that is specified for the paper output channel, is volumized. Content that is not intended for the paper channel is not included in volumization calculations.

You can volumize from an assembly root, a folder, or a section in the assembly. Bulk volumization may take a certain amount of time to perform, so the recommended way to volumize is by using Prepare To Publish.

Run a Bulk Volumization

Volumes you insert have a standard naming convention based on the volume publishing settings, which may be variable-based.