Miscellaneous
This field is used to prevent further editing to the Baseline value for Demographics and Metrics after a certain lapse of time.
What is Baseline Lock?
The first action that should be done on a milestone
What is Baselining the milestone?
Where are the activity dates captured if not created as a milestone?
What is a Task?
True or False: Submission milestones should be planned and completed through updating the appropriate fields with the pencil Edit icon.
False. Submission milestones should be planned and completed through workflows.
The object to capture necessary updates from health authorities or regulatory bodies
What is the Request for Information?
What is the Final Protocol Date?
What is the Previous Milestones section?
The act of disregarding a milestone that does not apply to not hold up processes downstream
What is Excluding Milestones?
The section on the Study / Country / Site where Submission milestones can be found.
What is the Submission / Approval Milestones section?
What is the lifecycle state of a newly created RFI record?
What is the New state?
The type of study that has the Registry - ENCePP section available
What is a Non-Interventional Study?
The Milestone that activates a Site, and Country/Study if applicable
What is the Site Ready milestone?
These milestones can be excluded by an end user
What are all milestones?
True or False: We cannot complete a submission milestone until its associated RFIs are completed.
False. RFIs have no impact on milestone completion.
This is an optional workflow during the submission lifecycle
What is the Track Acknowledgement workflow?
This activity needs to take place when a certain Enrollment Metric is not used on a study
What is excluding the First Subject ****** and Last Subject ****** milestones for that metric?
The user with the ability to uncomplete Essntl SR Docs Cmplt milestone
Who are Site level end users?***
All of the dependent items required for completion of a Milestone
What are the Tasks, Expected Documents, and Previous Milestones?
This workflow can complete all country level submission milestones
What is the Track Decision workflow?
The action which is taken when a Submitted Date is entered accidentally in Vault
What is Unsubmitting the milestone?
Who is Nobody? These are created automatically!
The time at which the Due Date of a Task is set
When is Task creation?
The user with the ability to uncomplete the Site Ready milestone
Who is the Business Admin?
How many submission milestones can be associated to a site?
The limit does not exist. :)
The workflows that should be used after a Rejected verdict for the Global Submissions
What are the Plan Resubmission and Mark Resubmission workflows?