Part 5: Publishing, Content Reuse and Lifecycle Management

Select the correct statements with regards to Test Publishing.

You will not be able to complete a Test Publishing if there are other users working on the same Submission
Content files are being published
PDF Analysis is performed as part of the validation
You will be unable to run a Test Publish if Preflight Publish was not completed
Test Publishing validates Hyperlinks
Test Publishing does not validate Structural Compliance with the DTD/Schema
Only Power Users can delete content from the Test Pool
You can choose to Exclude Working Documents as part Test Publishing

When doing a Preflight or Test publish, If the report shows a Yellow “closed” it means? Select all Applicable.

There are no Errors (Pass / Fail Issues)
There are Warnings (Best Practice Issues)
There are Errors (Pass / Fail Issues)
There are no Warnings (Best Practice Issues)

How can you tell if someone else is in the same submission as you?

docuBridge will throw you out of the application when someone else edits the same application
You will not be able save your changes
You will see coloured dots in the left bottom corner of the submission workbench
You will get a Pop-up Notice notifying you that another user is working on the same application

When do you push a sequence to the Publishing status?

On the same day as submitting to the Authority managing your application
After your test publishing validation report has no errors or warnings and before final publishing is performed
Every time changes have been made and need to be saved
Before doing the prefight publishing

True or False – Before completing a Final Publishing it is important to make sure there are no other users in the Application?

True
False

Select the correct statements with regards to Final Publishing.

You are not able to edit an Application once the Status has been changed to Publishing
The Status will Automatically be pushed to Publishing once a Test Publish has no warnings in the validation report
You will get a Pop-up Notice notifying you that another user is working on the same application before you do a Final Publishing
You are able to find your Validation report in your Info Panel
In order to re-run the Final Publishing, the previous one will have to be deleted from the Publishing Pool
All users are able to perform incremental publishing to the Publishing Pool
A Normal user will not be able to delete the final published output from the Publishing Pool

Select all the correct statements with regards to what should occur once a Validation issue is found.

Ignore all issues, docuBridge will fix it once Application is pushed to Submitted
If the Validation Report is not clear, view the XML file at the location indicated to see where exactly the errors and/or warnings occurred
Only power users are allowed to fix validation issues
Open Validation report to see which sections of the submission is causing the errors and/or warnings
All errors and/or warnings should be fixed, so that you can have a Green Closed report

Where would you find the Validation reports?

Dashboard
Info Panel
docuBridge – Application Ribbon
Application – Review Ribbon

Select the Validation error you would get – If you had multiple copies of a section that was not repeatable.

Element has Invalid Child Element
Invalid Child Element
Envelope has Invalid Child Element
Invalid Value
Missing Hyperlinks
Unreferenced File
Recommended Folder Name not adhered to
Recommended File Name not adhered to

Select the Validation error you would get – If a required field in the Administrative Information is left blank.

Element has Invalid Child Element
Invalid Child Element
Envelope has Invalid Child Element
Invalid Value
Missing References
Unreferenced File
Recommended Folder Name not adhered to
Recommended File Name not adhered to

Select the Validation error you would get – If we forget to fill in an eCTD attribute e.g. Substance.

Element has Invalid Child Element
Invalid Child Element
Envelope has Invalid Child Element
Invalid Value
Missing References
Unreferenced File
Recommended Folder Name not adhered to
Recommended File Name not adhered to

Select the Validation error you would get – If the PI and PIL are not hyperlinked.

Element has Invalid Child Element
Invalid Child Element
Envelope has Invalid Child Element
Invalid Value
Missing References
Unreferenced File
Recommended Folder Name not adhered to
Recommended File Name not adhered to

What do you do once your final publishing is complete and the submission is submitted? Select all Applicable.

Nothing
Add comments to Application in docuBridge to request the Status be changed to Submitted (Perform a Submit Request)
Right Click on Application, and use Custom Procedure to set Status Submitted
It will be updated automatically once final publishing is complete
If the regulatory activity status was already set to Under Evaluation, reset back to Submitted

What do you do with the test publishing once a final publishing has been completed?

Move all content from the Test Pool to an archive folder
Zip all content and only keep the zip file
Delete all test content
Rename published output in the Test Pool to indicate Obsolete

True or False – The Final Published Output of eSubmissions and eCTDs are saved in the same location?

True
False

Select the False statements concerning eCTDs and eSubmissions.

Both require Baselines
Both have defined Lifecycle Management
Both have the same basic content requirements
Both are submitted electronically
Both use XML backbones
Both have Validation Criteria
Both are equally efficient to evaluate
Both take the same amount of time to evaluate, even deep into the lifecycle

True or False – You can Validate an e-Submission / WebView/ NeeS Publishing?

True
False

Select what is validated when Validating (Test Publishing) a WebView / NeeS Publishing.

Table of Content
Files/ Folders
Life Cycle Management
PDF Files
Duplication of Content

Why would you Clone an Application? Select all the reasons.

To create a new sequence
To be able to submit in other regions
To create a Similar Application with a different Dosage (Pharmaceutical Form)
To create a response to a Regulatory Activity
To create a Master Application from a Reference Application
To create a Copy which is editable at a later stage

Select the ICH Sections that will need to be replaced when creating an application in a new region with an existing product.

Module 1
Module 2
Module 3
3.2.S – Substance
3.2 P – Product
3.2 R – Regional Information
Module 4
Module 5

How should documents be uploaded in general if they are added using the Life Cycle Operation NEW?

As a New Document
As a New Version
As a New Rendition
As a Related Document

How should documents be uploaded in general if they are added using lifecycle the LCM Operation REPLACE?

As a New Document
As a New Version
As a New Rendition
As a Related Document

What are the consequences of uploading a new version as a new document instead? Select all Applicable.

Multiple files will appear where only one file should exist
Assisted Compilation will not be able to compile a REPLACE as required
The overall time to manage the submission will be reduced
No clear current version will be recognisable
Content assignment reports will have to be created to determine where content was compiled
Long term, the time to manage content will be increased
Product data will be unstructured and not transparent
It does not matter, obsolete documents can be hidden as it is not important to show document change history

Why is the Sequence ID important? Select all Applicable.

It is best practice in the industry
To keep submission content well organized
To be able to efficiently and quickly compile a sequence
It's not really that important

When should a Sequence ID be created?

Before the first document/version for the sequence is uploaded or created in the system
After all the documents have been finalised for the sequence
Right before the sequence is published
Just in time for use with Assisted Compilation

How should the Sequence ID be created?

Submit Request
Re-distribution Request
Hide Request
Config Request
Delete Sequence Request
Delete Output Request
List Request

Select all the correct statements with regards to the Envelope.

With Every sequence the Application number needs to be updated
The Envelope needs to be updated with every Sequence
The Envelope is automatically updated once a new sequence is created
The Sequence and Related Sequence number need to be updated with every sequence created
The Envelope is associated with the sequence
The Submission Type needs to be updated with every sequence
The Additional Submissions needs to be updated with every sequence

How do you force replace a file that was not changed or versioned so that it is included in the publishing of the new sequence?

Drag and drop the same file to the Content Pane and replace the file with itself
Version the file to the next version but do not make any changes. Drag and drop the new version to the Content Pane
Tick the option Force Replace in the Configuration section of the Node Properties
Drag and Drop the same file to the submission Outline and drop it on the same node
It is not possible to replace content with the same content

Sort the following into the steps you would follow to search for Provisional Hyperlink.

Open Sequence
Click on Panes
Select "Find Hyperlinks" Pane
Click Find
Select Status "Source or Target Provisional"

View Answers:

True or False – It is possible that the hyperlink will no longer be in the correct location after a content is replaced with updated version where the text has shifted in the document?

True
False

Define: Source Provisional Hyperlinks.

The source document has been replaced since the hyperlink was created
The target document has been replaced since the hyperlink was created
The target document has not yet been set or has been removed since the hyperlink was created
The source document has not been updated although a new version is available
The source document is no longer the current version

Define: Target Provisional Hyperlinks.

The source document has been replaced since the hyperlink was created
The target document has been replaced since the hyperlink was created
The target document has not yet been set or has been removed since the hyperlink was created
The target document has not been updated although a new version is available
The target document is no longer the current version

Sort the following into the steps you would follow to update a TOC in lifecycle.

Select and update all TOCs in modules where content has been updated
Select and update all TOCs in modules where content has been updated again
Open Sequence
Activate Delta View

View Answers:

True or False – When changes are required in multiple applications with the same content, a new sequence has to be created one by one in each application individually?

True
False

True or False – You can make use of Batch Copy even if submissions are on different sequences?

True
False

True or False – In the Replication Dialog, it is possible to decide what content should be replaced on a node to node basis?

True
False

Part 5: Publishing, Content Reuse and Lifecycle Management

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