Miscellaneous
This document field is used to link a CV to the PI or Sub-I it should be collected for as an Expected Document
What is Person?
This is the most common way Subjects are created and edited in Vault
What is automatically through integration with an EDC system?
The person to contact with any Protocol Version complaints?
Who is Bobby?
Subjects can only be tracked at this level
What is Study Site?
These users can create reports
Who are all users?
The time at which a Sub I CV or PI CV Expected Document record will generate
What is Study Person creation from integration?
This is the time when a First Subject Screened milestone is completed
What is as soon as an Screened Date is populated on a Subject?
The field used to indicate how many protocol versions have occurred on the study
What is the Milestone Version field?
Informed Consent can be tracked at these levels
What are Study Country and Study Site?
This user can create flash reports
Who is a business admin?
When a Subject Transfer occurs, the Subject Transfer history will be clearly visible in a section on this Site (old or new site?)
What is the old site? (Outbound Subject History section - in the new site, they are just in the Subjects section)
This sequence of events happens when a First Subject Screened milestone is completed on a Site
What is the First Subject Screened milestone completion rolls up to the Study Country and Study?
The Ad Hoc Milestone needed to link the first Protocol to Submission milestones
What is the Initial Protocol Version?
Enrollment Metrics are tracked at these levels
What are Study, Study Country, and Study Site?
The way to tell what reports or dashboards are approved by the broader Merck business team
What is HQ Authorized?
A Task can have this number of Communications linked to it
What is 1?
This is the time when a Last Subject Screened milestone is completed
What is after the No Subjects/No Additional Subjects box is checked?
When a Protocol Amendment occurs, the Milestone Version value needs to be manually entered on the Protocol Version milestone on these levels only
What is Study, Study Country, and Study Site?
The method to move a Site to Closing that has subjects enrolled
What is completing the Last Subject Out milestone?
These are the two options for how Safety Distribution Dates can be set on a site
What are Direct Entry and Milestone?
A Communication can be linked to this number of Tasks
What is as many as necessary?
Out of Enrollment Metrics and Enrollment Milestones, these records update when a Subject is transferred to a different Study Site
What is Enrollment Metrics?
The associated milestone value of the Initial Protocol Version milestone for a net new Site after the Study is on their 5th Protocol Version
What is the standard template submission milestone?
The method to move a Site to Closing that never had subjects enrolled
What is the Change State to Closing workflow?
This object can be referenced to determine how Safety Distribution dates are set for a site using SIP
What is Country? (NOT study country)