Part 4: Content Reuse – Part Applications and Imported Submissions

Quiz Summary

0 of 20 Questions completed

Questions:

You have already completed the quiz before. Hence you can not start it again.

Quiz is loading…

You must sign in or sign up to start the quiz.

You must first complete the following:

Results

Quiz complete. Results are being recorded.

Results

0 of 20 Questions answered correctly

Your time:

You have reached 0 of 0 point(s), (0)

Current
Review
Answered
Correct
Incorrect

Question 1 of 20

1. Question
Why would you want to create Part Applications for Substances?
- To keep all documents together and neat
- It enhances efficiency if the substances are used in multiple applications
Correct

Incorrect
Question 2 of 20

2. Question
Why would you want to create Empty Part Applications? Select all Applicable.
- If you are creating submissions for other regions
- To keep all files together and neat
- When you add sections to your Life Cycle
- It assists in cloning applications for other regions
Correct

Incorrect
Question 3 of 20

3. Question
When does it make sense to create a part application for Substances?
- When creating an application for the first time
- When making use of the substance in 1 Submission
- When making use of the substance in 2 Submissions
- When making use of the substance in 3 or more Submissions
Correct

Incorrect
Question 4 of 20

4. Question
True or False – You can only have a maximum of 5 Part applications?
- True
- False
Correct

Incorrect
Question 5 of 20

5. Question
Sort the following into the process that you would follow to create an Empty Part Application for another region.
- Select the Template you would like to use
- Click on New – New Applications
- Open the Part Application in Edit Mode and remove the irrelevant content so that only Modules 1 and 3.2 R remain and Save
- Change Document Type to Part Application
- Fill in the Product ID as Empty Structure and all other Relevant Attributes and Click Create
View Answers:
Correct

Incorrect
Question 6 of 20

6. Question
What are the Nodes you would remove in Module 3 when creating a Part Application for a Region?
- 3.1 TOC
- 3.2 A – Appendices
- 3.2 S – Substance
- 3.3 – Literature References
- 3.2 R – Regional Information
- 3.2 P – Product
Correct

Incorrect
Question 7 of 20

7. Question
Which Button do you press to Merge content?
- Shift
- Alt
- Ctrl
- F5
Correct

Incorrect
Question 8 of 20

8. Question
Which Button do you press to Copy content?
- Shift
- Alt
- Ctrl
- F5
Correct

Incorrect
Question 9 of 20

9. Question
Where must Submission Exchange Packages be copied for Import?
- Exchange – Out
- Publishing Pool
- Exchange In
- Test Pool
Correct

Incorrect
Question 10 of 20

10. Question
True or False – A Zipped Folder can be imported from the Exchange?
- True
- False
Correct

Incorrect
Question 11 of 20

11. Question
Where do you find Exchange Packages after they are imported?
- My Attribute Checks
- Application Templates
- My Submission Follow-Ups
- New Exchange Applications
- Checked-out Files
Correct

Incorrect
Question 12 of 20

12. Question
True or False – Files in the Exchange Folder can be deleted once the content is imported?
- True
- False
Correct

Incorrect
Question 13 of 20

13. Question
Sort the following into the steps you would take in order to be able to make use of an imported Exchange Application.
- Select ALL Sequences
- Right Click on 0000 Sequence to Edit Attributes. Complete the necessary version attributes (Do the Same for next sequences if there are more)
- Find the Application in General Search 3
- Complete the Dialog requiring information for Product ID, Country / Region and Application Folder Name
- Go to docuBridge Folder – new Exchange Application
- Right click to select Custom Procedures – Distribute Exchange Submission
View Answers:
Correct

Incorrect
Question 14 of 20

14. Question
True or False – You can still rename an application folder in the eCTD Repository after it has been imported to docuBridge?
- True
- False
Correct

Incorrect
Question 15 of 20

15. Question
Select all the reasons you would import an eCTD.
- To Continue the Application of an eCTD started by a different company
- To be used as a Baseline Application
- It is an ICH Requirement
- To be able to continue the lifecycle of an application compiled by a consultant
- To have a copy of a Reference application from another region to replicate from
- To have a record of an application compiled by a parent company or affiliate compiling on your behalf
Correct

Incorrect
Question 16 of 20

16. Question
Which location do you Import an eCTD from?
- CD Pool – Repository – eSubmission
- Exchange – In
- CD Pool – Repository – eCTD
- CD Pool – Repository – Part
Correct

Incorrect
Question 17 of 20

17. Question
Where do you find eCTD Submission after they are imported?
- My Attribute Checks
- In the General Searches
- My Submission Follow-Ups
- New Exchange Applications
- Checked-out Files
Correct

Incorrect
Question 18 of 20

18. Question
True or False – Files in the Repository must be deleted once the content is imported?
- True
- False
Correct

Incorrect
Question 19 of 20

19. Question
Where are the hyperlinks stored in a submission?
- The Hyperlinks are saved on the Node, and not the document itself
- The Hyperlinks are saved in the content, and not the on the Node
Correct

Incorrect
Question 20 of 20

20. Question
Select all the correct statement with regards to the Elevation of files and Elevated Files.
- It is good practice to Elevate all files of a section even if they do not need to be versioned
- We Elevate files so that they are available in docuBridge for versioning purposes
- Once a eCTD is imported, files of that particular submission are stored in docuBridge
- We can Elevate files from an unlocked Application when in Edit Mode
- It is not possible to Elevate a whole section within the Application, files have to be Elevated one by one
- Elevated files lose all of their Hyperlinks
- When a File a Elevated, the Word and PDF renditions are available
Correct

Incorrect

Part 4: Content Reuse – Part Applications and Imported Submissions

Quiz Summary

Information

Results

Results

Categories

1. Question

2. Question

3. Question

4. Question

5. Question

6. Question

7. Question

8. Question

9. Question

10. Question

11. Question

12. Question

13. Question

14. Question

15. Question

16. Question

17. Question

18. Question

19. Question

20. Question

Frequently Asked Questions