Import eCTD Applications

When you import an eCTD application you can import an entire eCTD with sequences. The eCTD sequences are imported into an existing application with the required views. The following files are required to import an eCTD:

— The index.xml in a folder named based on the sequence number. — The regional XML in the M1 folder. — All of the necessary DTD files.

Example:

0000


index.xml m1 us-regional.xml util dtd <DTD files> stylesheet <Stylesheet files>

Content files are not required for eCTD import. If you have only an index.xml file, you can substitute placeholder files (with Leafs removed) for the regional.xml and util folders from another sequence. During the import, if content files are found to be missing, they will not be referenced in the assembly: only leafs will be created. To prevent import of existing content files during an eCTD import, use the Import Leaf Files Only option.

The eCTD importer sets the assembly status for the first sequence in an application to In Draft instead of

Approved.

Once you import the eCTD application, you can create new sequences that are based on the existing lifecycles either to continue these lifecycles or for archival purposes. Any imported sequences must be in the correct file/folder format.

Each sequence folder is imported as a separate sequence. All files that are referenced by the eCTD XML leaf elements become assigned files underneath each leaf, pointing to this repository for content. The entire eCTD XML is imported as assembly metadata, including: leaf IDs, modified files, and envelope information.

You can import and add to the same application lifecycle more than once. In this way you can import sequences

0000 and 0001, and then when you have added sequences 0002 through 0005 to the folder you can import again. The subsequent eCTD Import will process only the newly added sequences.

When performing an import of an existing eCTD, the import progress is reported in the server.log file. The Job Request Details also show messages about each sequence that is imported. The administrator can monitor the server log to follow the overall progress of the import and see more detailed messages, such as timestamps and Oracle information.

Although other repositories may be available in the eCTD XML import utility, only secure file systems, OpenText Content Server, and Documentum repositories are currently supported.

Note: To import China assemblies, verify that the following assembly templates exist in the system:

— CN eCTD Module 1 v.1.0.xml

— CN eCTD ICH Module 2.5 v.3.2.xml

— CN Clinical Study Report (VV5-0).xml

— CN Nonclinical Study Report (SEND Dataset).xml

— CN Nonclinical Study Report.xml

To import EAEU assemblies, verify that the following assembly template exists in the system: — EAEU Template v1.0.xml

To import GCC assemblies, verify that the following assembly templates exist in the system:

— GCC eCTD Module 1 v1.5 - GCC.xml — GCC eCTD Module 1 v1.5 - NP.xml

Requirements for Successful eCTD Imports

To import eCTD assemblies successfully, the following conditions apply.

— In Data Administration > Assembly > Assembly Subcategories Values, do not disable the subcategory values for eCTD submissions.

— When importing US-3-3 eCTDs, the application code in the XML must match the application code in Ennov InSight

— The index, regional, and content files must follow the naming convention filename.extension.

This is not an issue on secure file systems. However, it is critical in a DMS where the file name may not have the extension appended, but rather, is identified as a format type. As an example, a file named index with a format type of xml will not import, but index.xml will import. The same is true for content files. For example, cover-letter.pdf will import but cover-letter with a format type of pdf will not.

— For a bulk eCTD import, the Product Family and Application entities must exist in Ennov InSight .

Import an eCTD Application

You can import an existing/new eCTD into an application and give it a new sequence or assembly prefix.

Note: If the import is to an existing Application (i.e. there are existing Sequence Assemblies) then the eCTD Import will not prompt you for the Publishing Settings Library Template to use, but will instead use the Submitted View from the previous existing Sequence as the basis for the APL for the imported Sequences.

To import an eCTD application:

Click a link for the application into which you want to import an eCTD application. The Application Attributes page opens.
Click to open the Import eCTD to Application window.
Note: If you are importing eCTD submissions, select eCTD as Import Type. For EAEU submissions, select EAEU XML with embedded PDFs in Import Type drop down. See: Ennov InSight Best Practice: EAEU Submissions for details.
Click Browse, locate and select the eCTD application folder to import, then click OK.
For EAEU XML with embedded PDFs Import type, EAEU XML Location, Output Document type, DMS Versioning Scheme fields will appear. Refer: Import section of Ennov InSight Best Practice: EAEU Submissions for details.
Select the Publishing Settings Library template.
Note: Publishing Settings Library field is enabled only under the following conditions:
— New Application: If the import is to a new Application (No existing Sequence Assemblies) then the eCTD Import will prompt you for the Publishing Settings Library Template to use as the APL for the imported Sequences.
— If the Publishing Settings Library Template does not contain a Publishing Settings entry, the system displays an error message: The Publishing Settings Library Template must contain an entry for Publishing Settings, please select another Template to use.
In the Sequence Name Prefix box, enter a prefix to use for sequences.

In the Assembly Name Prefix box, enter a prefix to use for the assembly name.

Automatically, each imported leaf element is assigned with the Published leaf status, or any other leaf status that has the Internal System Status set to "PUBLISHED".


Option	Action
To import only XML leafs found in the eCTD XML, without importing references to the content files:	Select Import Leaf Elements Only. This prevents Ennov InSight from creating and assigning content document elements below each leaf during the import. It can also improve import speed significantly, as the content files are not necessary for subsequent sequence publishing. This option captures all lifecycle operations correctly, and it prevents republishing of submissions already published. If extracts and renditions are needed for the imported documents, you can run create renditions and extractions from each assembly.
To include orphan leaf elements in the import:	Select the Import Orphan Leaf Elements option. This informs the Ennov InSight system that some of the eCTD XML could be incorrect in that it might contain references to leaf IDs or files that do not exist in the current view of the application. This can occur, for example, if an identical leaf is replaced twice, or if a deleted leaf is replaced. During a normal import, Ennov InSight fails when it finds these instances. However, if the Import Orphan Leaf Elements checkbox is selected, Ennov InSight ignores orphan leaf instances and creates new leaf elements instead.

Click Next.
The Summary page indicates the import has been scheduled.
Click Finish.

For performance reasons, the status of the import is logged to the server.log file on the Application server (rather than to the job requests).

Bulk eCTD Import Wizard

Use the Bulk eCTD Import Wizard to migrate multiple eCTD submissions to Ennov InSight from another system in a supported document management system (DMS).

The Bulk eCTD Wizard is available on the Ennov InSight Wizards menu when you have a license for the Electronic Lifecycle Publishing (ELP) module and the following permissions are set in Security Administration:

— For the ELP module, Security permissions must be WRITE or ADMIN

— In the Home Page Access section, Import eCTD and Bulk Import eCTD options must be set to Yes

— In the Entity Security section, permission for Events must be WRITE or ADMIN to make the Create

Grouping Events option available on the Bulk eCTD Import window

The Bulk eCTD Import process matches the Application Code within the XML being imported.

Bulk eCTD Import is not supported for EAEU submissions.

Prepare for Bulk eCTD Import

The Bulk eCTD Import process matches the Application Code within the XML being imported. This process is executed by a job named Preparing for Bulk eCTD Import. This job finds all valid applications in the source folder and parses regional.xml files to find an application number to match with an application code in Ennov InSight .

When you click on the details of the Preparing for Bulk eCTD Import job, you will see messages that show the matching application code found in the system. This is the application where the imported sequences are located.

Bulk Import Prerequisites

The appropriate Application must exist in Ennov InSight prior to performing a bulk eCTD import, you will need to create the applications before performing the bulk import.

If the system encounters a sequence folder without a valid 'util' folder, sequence XML, or valid regional XML file during the bulk import process, the following message appears: "WARNING: The Application

located here:"<path to application>" failed to import: Required files were not found, ensure all Sequence folders contain a valid 'util' folder, and/or XML file."

Applications Other Than US 3.3

For Applications other than US 3.3 Applications, the Preparing for Bulk eCTD Import job will look in the

Sequence folder with the highest sequence number first. This is to account for Europe’s "UNKNOWN" Submission

Number in early sequences. To ensure a successful import, set the Application Code within Ennov InSight to the Application Code/Application Number/Application Tracking Number in the last XML in the Application folder.

When there is no regional.xml in the folder with the highest sequence number, or when there is a regional.xml without an Application Code/Application Number/Application Tracking Number, the system checks the folder(s) with the previous sequence number - continuing until the Application Code/Application Number/Application Tracking Number is found. If no Application Code/Application Number/Application Tracking Number is found, the application is skipped and the following message appears in the log: "WARNING: The

Application located here: "<path to application>” failed to import: The Application Code was not found in the regional.xml, please ensure that folder contains a valid application."

GCC, MRP, DCP Applications

For GCC, MRP, and DCP, multiple Application Codes can exist for the same Country, or for different Countries within the XML. The list of all application codes within the XML is matched against an Application Code within Ennov InSight . US 3.3 Applications

For US 3.3 applications, the Preparing for Bulk eCTD Import job will look in the Sequence folder with the lowest sequence number first. To ensure a successful import, set the Application Code to the Application Number in the us-regional.xml with the lowest number.

ZA 3.1 Applications

The Application ID from regional.xml file will be used to identify Application Code value.

EU 3.1 Applications

An Application Tracking Number is used to identify an application. When there are multiple Application Tracking Numbers, even a single instance of an Application Tracking Number matching an application initiates the process of bulk import. If there are multiple matches, the bulk import process stops.

WHO 1.0 Applications

Import of WHO applications is possible only using eCTD import and not via bulk eCTD import. For information on eCTD import, see Administrative Activities > Import eCTD Applications in the Ennov InSight Administration help module.

UA 1.0 Applications

A Submission Number is used to identify an application. When there are multiple Submission Numbers, even a single instance of a Submission Number matching an application initiates the process of bulk import. If there are multiple matches, the bulk import process stops.

AU 3.2 Applications

Import of AU applications is possible using eCTD import and via bulk eCTD import. The e-identifier identifies the applications for bulk import. For information on eCTD import, see Administrative Activities > Import eCTD Applications in the Ennov InSight Administration help module.

Application Code Matching Warnings

If no matching Application Code is found, the application is skipped and the following message appears in the log:

"WARNING: The Application located here: "<path to application>" failed to import: The Application Code(s) "<coma separated list of application codes from xml>" cannot be matched in the system, please create the Application and try again."

When there are multiple matching Application Codes, the system includes the Application Code and Folder path to the Application within the Job Messages for that Job with the following message: "WARNING: The Application located here: "<path to application>" failed to import: The Application Code(s) "<coma separated list of application codes from xml that matched multiple applications>" matched multiple Applications in the system."

Note: Canceling a Preparing for Bulk eCTD Import job will not cancel individual eCTD import jobs that have already been prepared and are in the queue.

Define Default Values for eCTD Bulk Import

Ennov InSight provides the ability to perform batch imports of eCTD applications using the Bulk eCTD Import wizard.

The bulk import functionality requires specific default values for the number of concurrently running import jobs (default is 3), and for the frequency that the system checks for a free place in the queue (in seconds, default is 300).

To define the eCTD Bulk Import values for your system:

Go to the directory C:\InSightManager\server\all\conf\insight and open the insight.var file in a text editor.
At the bottom of the insight.var file, add the following records:
— bulk.ectd.import.limit = ₃ (the number of concurrently running import jobs)
— bulk.ectd.import.update.interval = 300 (frequency of checking if there is a free place in the queue, in seconds)
Save the insight.var file.

Use the Bulk eCTD Import Wizard

You can use the Bulk eCTD wizard to import multiple submissions to a supported document management system. Prior to running the Bulk eCTD Import, all applications should be configured correctly, as described in Prepare for Bulk eCTD Import.

To perform Bulk eCTD Import:

In Ennov InSight , open the Wizards menu and select Bulk eCTD Import.
In the Publishing Settings Library field, select the Publishing Settings Library Template (PLT) to create Assembly Specific Publishing Settings Libraries (APL) for the imported eCTDs.
This field is applied according to the following rules for new or existing applications:
— New Application – If the import is to a new Application (there are no existing Sequence Assemblies) then the Publishing Settings Library Template selected in this field is the APL for the imported Sequences.
— Existing Application – If the import is to an existing Application (there are existing Sequence Assemblies) then the eCTD Import uses the Submitted View from the previous existing Sequence as the basis for the APL for the imported Sequences.
On the Import Location field, click Browse to locate source of the eCTDs to import.
Select the folder containing all Applications with their nested eCTD sequences. It is prerequisite to have collected all eCTD imports into one folder.
In the Import Orphan Leaf Elements field:
— Select Yes to include orphan leaf elements in the import.
— Select No and Ennov InSight ignores orphan leaf instances and instead creates new leaf elements.
In the Import Leaf Elements Only field:
— Select Yes to import only the XML leafs in the eCTD XML, without importing references to the content files.
— Select No if extracts and renditions are needed for the imported documents. You can run Create Renditions and Extractions from each assembly.
Note: Each imported leaf element is automatically assigned with the Published leaf status, or any other leaf status that has the Internal System Status set to "PUBLISHED".
In the Use Application Code for Prefixes field:
— Select Yes to use the existing application codes as prefixes.
— Select No to enter a new Sequence Prefix and Assembly Prefix.
In the Create Grouping Event field:
— Select No (the default), and no grouping event is created.
— Select Yes and use the default (Legacy Submissions) or enter a different Event Name.
If Create Grouping Event is Yes, the Close Event as Approved field appears. In the Close Event Approved field:

— Select No to keep the Event open, it will not be closed.

— Select Yes to close the Event with the status Approved. If Yes is selected, the Event Name field is created and required (limit 200 characters). The Event Name default is Legacy Submissions. If any submissions failed to import, the Event is not closed.

On import, all Sequences are associated with the defined Event and the Application. If any of the imported sequences already exist in the Application, they are not added to the defined event. If set to No, all Sequences will only be associated with the Application

When imported:

— If an Event with the same name already exists and is not closed, the sequences are added to that Event. The Status Date of the Event is not updated.

— If more than one Event with the same name already exists and is not closed, the sequences are added to the most recent open Event, according to the creation date.

— If an Event with the same name already exists and is closed, a new Event is created with the same name and a sequential number added as a suffix. New sequences are added to this Event

For each country on the Application, an Event-Country is created. The Status is set to the default Event status. The Status Date is set to the date of import.

Note: Because many regions do not contain a submission date, and in some regions the submission date is dropped between specifications, it is not possible to obtain a valid date for all eCTD regions.

Click Next, and the system parses the XMLs to determine the Application Codes.
The Application Codes are matched to the Application Codes within Ennov InSight , and the system imports the eCTD structures. The Summary window displays this message: “The bulk eCTD import has been scheduled successfully. Choose Go To > Job Requests for the status.”
Click Finish.