Part 2: Submission Quality Control

According to the images, Identify and Sort functionalities that Appear in the docuBridge Navigation Bar. You can navigate through the Images, using your Mouse wheel or Keyboard down-arrow.

Why would you want to activate the eCTD Setup Filter? Select all Applicable.

Select the 4 Section Categories that are repeatable.

Select all the Sections that are repeatable.

Sort the Meanings of the coloured triangles according to the images.

Why do we use MNF1 for the Manufacturer in the (P) sections of our applications?

True or False – Nodes can be added once application has been submitted?

Select all the correct answers: How do you know if an eSubmission Code is assigned to a node?

True or False – When renumbering structure numbers you need to select the whole module?

What Efficacy is allowed? Select all applicable.

What section of the outline do you select to restructure the document structure numbers?

Where would you assign which documents should be published as single or combined documents?

Select the documents that MUST be published as single files according to ICH.

When do you typically assign Publish as Combined Document?

Where do you mark a node as optional if no content will be provided for that section?

Select the correct statements with regards to Preflight Publishing.

Select all the possible reasons that a Node might have invalid Attributes.

Sort the following steps in the correct order of how you would go about searching for nodes with identical content in a specific module.

All content in the submission should have an eSubmission code assigned to it except what?

Where would you find the option to turn the Attribute viewer on and off?

What is the Maximum Characters that should be used for eCTD attributes and Document Attributes that convert to eCTD Attributes? (Substance, Manufacturer, Indication, etc.)

Select the items meant to be used in a Study Title.

Why are some parts of the Dummy Nodes in ALL CAPS?

What do you do with Dummy Nodes once you have verified that your content meets Best Practice Leaf Title recommendations?

In which Ribbon is the option to create a Highlight in?

True or False – You can create Highlights in a Locked Application?

How do you create a Margin Comment on a page?

Can you create Annotations in a Locked Application?

How would you go about exporting Annotations? Sort the following in the correct order.

How would you go about assigning a Review State? Sort the following in the correct order.

Sort the following Review Statuses Available in Standard Configuration according to the images provided.