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Select the correct statements with regards to Test Publishing.
When doing a Preflight or Test publish, If the report shows a Yellow “closed” it means? Select all Applicable.
How can you tell if someone else is in the same submission as you?
When do you push a sequence to the Publishing status?
True or False – Before completing a Final Publishing it is important to make sure there are no other users in the Application?
Select the correct statements with regards to Final Publishing.
Select all the correct statements with regards to what should occur once a Validation issue is found.
Where would you find the Validation reports?
Select the Validation error you would get – If you had multiple copies of a section that was not repeatable.
Select the Validation error you would get – If a required field in the Administrative Information is left blank.
Select the Validation error you would get – If we forget to fill in an eCTD attribute e.g. Substance.
Select the Validation error you would get – If the PI and PIL are not hyperlinked.
What do you do once your final publishing is complete and the submission is submitted? Select all Applicable.
What do you do with the test publishing once a final publishing has been completed?
True or False – The Final Published Output of eSubmissions and eCTDs are saved in the same location?
Select the False statements concerning eCTDs and eSubmissions.
True or False – You can Validate an e-Submission / WebView/ NeeS Publishing?
Select what is validated when Validating (Test Publishing) a WebView / NeeS Publishing.
Why would you Clone an Application? Select all the reasons.
Select the ICH Sections that will need to be replaced when creating an application in a new region with an existing product.
How should documents be uploaded in general if they are added using the Life Cycle Operation NEW?
How should documents be uploaded in general if they are added using lifecycle the LCM Operation REPLACE?
What are the consequences of uploading a new version as a new document instead? Select all Applicable.
Why is the Sequence ID important? Select all Applicable.
When should a Sequence ID be created?
How should the Sequence ID be created?
Select all the correct statements with regards to the Envelope.
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?
Sort the following into the steps you would follow to search for Provisional Hyperlink.
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?
Define: Source Provisional Hyperlinks.
Define: Target Provisional Hyperlinks.
Sort the following into the steps you would follow to update a TOC in lifecycle.
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 or False – You can make use of Batch Copy even if submissions are on different sequences?
True or False – In the Replication Dialog, it is possible to decide what content should be replaced on a node to node basis?