Study Request Form
Approximately how many fields are required to create a Study Request?
What are 20+ fields?
These are two characteristics to identify a field that is always required.
What are yellow and an asterisk?
The first state of the Study Country record after creation
What is Candidate?
Out of Study, Study Country, and Study Site, which of these three can be put On Hold?
What are Study, Study Country, AND Study Site (all 3)?
The Date field that Completes most milestones
What is the Actual Date?
After the Study Request is completed and the Study is created, this action needs to happen before a Study Manager can edit the Study
What is assigning Study Personnel?
This action must be taken if assigning a Study Organization that has GCP Compliance value noted
What is checking the GCP Status Acknowledgement field?
This user can create Sites within a Study Country
Who is the Business Admin?
This type of activity moves a Study, Study Country, or Study Site to Cancelled or On Hold
What is a workflow?
Multiple Location records in the Global Directory can be related to one of this object
What is Organization?
The users who are able to approve Study Request Forms
Who are CSDI Business Admin?
The Milestone that changes the Study from Candidate to Planning
What is the Study Approved Date?
True or false: The CRM can edit sites in their study country, and the Site Monitor can edit the parent country of their site
False: the CRM can edit sites, but the Monitor can't edit countries.
This sequence of events happens when a Study is Cancelled
What is Study Country cancellation and Study Site cancellation, and exclusion of ALL study/country/site milestones?
This occurrence triggers the release of new milestones on a Study, Study Country, or Study Site
What is a lifecycle state change?
This state of the Study Request record that has a Study created as a result
What is the Reviewed State?
A field that must be selected for Studies with EU CTR countries
What is the EU CTR Participating Checkbox?
The fields necessary to complete the On Hold workflow
What is the On Hold Start Date and On Hold Notes?
This user can Return a Site from Not Selected
Who is the Site Monitor? (or any user with site-level edit abilities. But only BA can return from Cancelled!)
The field that will change the Milestone to the Planned state
What is the Latest Estimate Date?
The Section of the Study Request to link to a Study that has been created
What is the Used for Study section?
A Study with this Therapeutic Area requires a Subtype of that Therapeutic Area to be entered
What is Oncology?
This field becomes available on a Study Site if it is marked as a Satellite Site
What is Lead Site Number?
This sequence of events happens when a Study is put On Hold
What is Nothing? There is no cascade!
The Baseline Date, if left blank, will populate with the data from this Milestone field
What is the Latest Estimate Date?