Leaf Statuses

You can select the leaf elements to be published. When the Publish Request page is initiated, in the Include Leafs with Status box select the leaf statuses of leafs you want to be published. The leafs with selected statuses are included in the electronic publish to generate output leaf files.

— This option does not affect the XML generation. For XML, all leafs are included, independent from the status assigned.

— After publishing is completed, the leaf statuses of leafs that have publishable elements are changed automatically to Published.

— For the Publish to a Single File option, all leafs are published to a single file, independent from the selected statuses.

— For the All Leaf Elements or Selected Leaf Elements options, only leafs with the selected leaf statuses are published.

— For the All Leaf Elements and XML and Selected Leaf Elements and XML, the backbone files and only leafs with the selected leaf statuses are published. When you do not specify the leaf statuses in the Publish Request, then only the backbone files are published.

— For the Paper Publish only, all leafs under volumes are published, independent from the selected statuses.

The publishing job fails, if:

— All leafs have no publishable elements.

— There are no leafs in the assembly with the selected leaf statuses.

After Submitting a Publishing Request

When you create a publish request, a confirmation message indicates whether the request was successful and an audit trail is created.

The publish request is sent to and processed by the server as follows:

— If you chose to prepare for publishing automatically, Ennov InSight checks the rendition status of each source document before trying to publish the submission.

— Any renditions that are missing or out-dated are queued for processing.

— Ennov InSight holds the publishing request until all renditions are created for source files in the submission.

— If a rendition fails, a message is saved in the publish log and the leaf including that document is not published

— If a rendition fails for one or more source files, a message is saved in the publish log and the submission is not processed.

— If all renditions are created successfully, they are written to the DMS as renditions of their respective documents and the system continues to process the submission.

— You are notified when the job is completed and whether it was successful.

Note: When a job has left the queue to be processed, it cannot be cancelled from the InSight job requests window. Jobs must be cancelled immediately if they are to be stopped, in the Web interface.

Viewing a Publishing Request

You can generate a Publishing Request query to view all or specific publishing requests.

To view a publishing requests:

1. Choose Go To > Job Requests. The Job Requests page opens.
2. Do any of the following:

   Option	Action
   To view the job request:	Click the User Name arrow and choose the user who submitted the job requests.
   To choose the date range during which the requests were submitted:	Click the date arrows.
   To view the specific publishing request: Enter the name of the specific publishing request you want to view:	In the Job Name box, enter the name of the specific publishing request.
   To view the publishing request:	In the Job Status box, choose the statuses of the publishing request.
   If you do not want to include in the query:	Under Selected Columns, choose any data and click <-- to move it to the Available Columns box.
   To change the order in which columns appear in the query results:	Choose Selected Columns and click up or down.
   To sort the job requests:	Under Available Sort Orders, choose the columns and click <-- to move it to the Available Columns box.
   To change the order in which columns appear in the query results:	Choose selected sort orders and click up or down.

3. Do one of the following:

   Option	Action
   To generate the query:	Click Search.
   To clear your choices and start again:	Click Reset.
   Option	Action
   To save your choices as a query you can use again:	Click .

4. Do any of the following:

Publishing Request Results

Each publishing request that fits the criteria you specify on the Job Requests page appears on a row in the resulting report. If an error has occurred during publishing, an error message is returned. The message that appears in the Job Message column is a link you can click to view the details of the message.

When publishing, if Prepare To Publish has been selected, the process is initiated before the publish function. The Job Requests page shows the prepare to publish running prior to showing the publish execution.

Suspended processes (either purposefully or through an error) may cause Ennov InSight to incorrectly report jobs as completed in the job requests report. For all jobs that require to be involved, the following Job Statuses exist to identify the job progress:

— Scheduled

— Started

— Waiting for Ennov InSight

— Waiting for

— Processing Results

— Completed

— Failed

— Canceled

The following table describes the different statuses of the publishing job results.

View a Job Message

You can track the progress of your publishing job on the Job Message page.

To view a job message:

1. Click a link in the Job Message column in the Job Requests query results.
2. On the Job Message page, do any of the following:

Note: Suspended processes may cause Ennov InSight to incorrectly show jobs as completed in the Job Request query results.

Cancel Publishing Requests

Only an administrator can delete a publishing request submitted by another user.

You can cancel your own publishing requests under certain conditions.

— You have the appropriate security privileges. — The job has not already been completed.

You can only cancel in-progress jobs that have reached the server, which is indicated by the Job Details. When doing so, the currently processing sub-task is completed and then the parent job is canceled.

Warning: If you attempt to cancel while the job is still being processed by Ennov InSight (before you see any Job Details), then resubmit the same job, you could cause the database to lock.

Cancel a Publishing Request

You can cancel a publishing job before processing if you have the appropriate security permissions.

To cancel a publishing request:

1. Click Go To > Job Requests.
2. On the Job Requests page, enter the information for the publishing request you want to cancel.
3. Click Search.
4. In the query results, click Cancel Job in the Cancel Job column for the publishing request.
5. Click OK when you are prompted to confirm the cancellation.

Export Submissions

From Ennov InSight , you can export published output from one repository location to another repository location.

When you publish a submission, Ennov InSight creates eCTD files at the submission output location you specified in the publish request. This enables you to copy completed publications to their final storage, archival, or dispatch location in the repository.

Export a Published Submission

You can export a published submission from the repository you specified in the publish request to another repository.

To export a published submission:

1. Click a link for the assembly you want to export.
2. Right-click the root and choose Export Published Output. The Export Published Output dialog box opens.
3. In the Source Location box, specify the output location for the assembly. You can click Browse under the

   Source Location box to choose the published output from a DMS repository or a secure file system.

4. In the Destination Location box, specify the DMS repository or secure file system to which you want to copy the published output. You can click Browse under the Destination Location box to choose a location in a DMS repository or a secure file system.

   Note: When exporting published output, you can only export to an existing location within the DMS repository or secure file system. If the path that is entered in the output location attribute does not exist, the export will fail.

   Note: For EAEU submissions, provide the valid values for the Source Location and Destination Location fields. For Source Location, a folder containing the index-r-022.xml file must be specified. See: EAEU Submissions Best Practices document for details.

5. If you are exporting to a DMS repository, do the following:

   Option	Action
   In the Output Document Type drop-down list:	Select the object type to be created for the exported documents. Use dm_document for Documentum.
   For DMS Versioning Scheme:	Select either Minor to version existing documents as a minor version, for example 1.1, or Major to version existing documents as a major version, for example 2.0.

6. Click OK.

Note: For EAEU submissions, select Embed PDFs into EAEU XML? and proceed further. See: EAEU Submissions Best Practices document for details.

Ennov InSight processes the export as a batch job and the following occur:

— A new document/file is created for each repository document that is a descendant of the source folder.

— A new folder is created for each repository folder that is a descendant of the selected folder.

— Only the CURRENT version of a particular source repository's document or folder is exported.

— The document or folder name attribute is set to the repository object name for the document file.

— The documents are placed as children of the matching folders to mirror the hierarchy in the repository.

— Virtual documents (with and without content) and objects with no content are ignored.

— Destination Not Found text will be used to stamp TOC entries or cross-references where the destination is undefined. By default it is set to blank, but in some processes it may be helpful to set it to some text indicating an issue with a TOC entry or cross-reference.

About Distribute Published Output as Rendition

The Export Published Output functionality includes the ability to distribute published output as a rendition of a virtual document or a secure file system document.

To distribute published output as a rendition, the source must be a single PDF file, such as the resulting PDF from performing a Publish to Single File publish, and the destination file cannot be a PDF (since that would be a rendition of itself).

If the destination file is a virtual document, it cannot be an object with no content. If you are exporting to a secure file system, there must be an existing pub folder in the same directory as the destination file.

Ennov InSight will distribute the PDF to the pub folder. Existing PDF renditions are overwritten when performing subsequent distributions.

Distributing Published Output as a Rendition

You can distribute the published output as a rendition of a virtual document or a secure file system document using the Export Published Output.

To distribute published output as a rendition:

1. Right-click on the root node of an assembly and select Export Published Output.
2. In the Source Location box, browse to select a PDF file.
3. In the Destination Location box, browse to select a virtual document or secure file system file.
4. Click OK.

Note: The options for Output Document Type, Status of Documents, and DMS Versioning Scheme are only applicable when exporting folders. They do not apply to exported files.

Export a Source File to a Destination File as a Rendition

Using the Export Published Output function you can specify and export a source file to a destination file (publish a rendition), with certain limitations. The source must be a PDF file, and the destination file cannot be a PDF (since that would be a rendition of itself). If the destination file is a virtual document, the root must already have content.

To export a source file to a destination file as a rendition:

1. On the root node of the assembly, right-click and select Export Published Output.
2. In the Export Published Output window, browse to select a PDF file for the Source Location.
3. For the Destination Location, browse to select either a non-PDF file or a Virtual Document (VDM).

   The options for Output Document Type, Status of Documents, and DMS Versioning Scheme are applicable only when exporting folders. They do not apply to exported files.

4. To export the selected file to the specified destination, click OK.

If the source file and the destination file have the same name, the source file will overwrite the destination file without notice.

Review an eCTD

You can review an eCTD for XML files and folder/file structure using Ennov InSight Validator.

See View Index and Regional XML Files in a Web Browser in the Ennov InSight Validator User Guide.

You should still perform a typical electronic submission PDF validation by opening files in Acrobat and checking bookmarks and links.

Note: PDF files launched from a supported browser view of the index.xml or xx-regional.xml might not open to bookmarks and page because of the Acrobat embedding specifics. Use the XML links only to verify that the file can be opened. Do not rely on this to verify the PDF files.

View Study Tagging Files (STFs)

To view STF XML files in Google Chrome:

1. Open files in Google Сhrome by right-clicking them in Windows Explorer and choosing Open With > Google

   Сhrome.

   Alternatively, you can open STFs by clicking their links while viewing the index.xml in Google Сhrome.

2. For each STF, verify that the Study Title and Study ID are populated and correct.

   If the study is in a section that requires extra STF category metadata, verify that as well.

   Note: Only studies contained in 4.2.3.1, 4.2.3.2, 4.2.3.4.1, and 5.3.5.1 require various combinations of the four category elements (species, route of administration, duration, type of control). Studies in other sections can omit the category metadata.

   Each leaf referenced in the STF needs to correctly point to the leaf ID in the index.xml file. When the leaf ID is correctly referenced, both the Document Title and Relative Filename are populated on the STF. If the ID is not referenced properly to the index.xml, these fields are blank.

3. Click the blue Relative Filename links to ensure that leaf files can be launched.

Each leaf in the STF must have a valid file-tag as described in the STF implementation guide. Tags are displayed in the STF as [us] nonclinical-data or [ich] study-report-body. The text in square brackets is the info-type tag and the rest of the text is the file-tag. Any tags that are misspelled or use the wrong info-type are highlighted in red.