When I archive a document, I need to change the count to the....
What is Placeholder?
100
I am an investigational new drug safety report
What is INDSR?
100
When drug is shipped to me, it's because I have a separate CRTN number than my main mother ship.
What is Satellite Site, Method 2?
200
Document Name PD Form 24
What is Laboratory Normal Value
200
For documents that do not have any date information or where no date applies.
What is a 11-November-1911?
200
I get an email stating I can take training before I get access to the CTSP (Clinical Trial Safety Portal).
What is user SDD role set-up in CTMS?
200
I am used to track drug shipment and non-drug supplies?
What is Address List?
300
Document Name is PD 38
What is Delegation of Authority Log
300
I am a widget that is set up to easily and quickly access to frequently used sites, folders, and placeholders of any other type of document available in the eTMF system
What is Favourites?
300
I represent a physical location of an organization/corporate entity/department
What is an Account?
Investigational Site (hospital, department, clinics, private practice…)
EC/IRB
Health Authority
Service Provider
Pharma-Partner
Roche Company
Service Provider
Partnership/Collaborative Companies
400
Document Type is PD30
What is Study Initiation Form - PAV Form
400
My hierarchy is: 1) Compound, 2) Theme, 3) Study Number, 4) Country, 5) Site, 6) RRM Zone, 7) RRM Section, 8) RRM Document Type
What is Folder Structure?
400
I no longer need to receive safety document distribution, so now this is my new status
What is Inactive?
400
The Role of "Safety Responsible" associated to me in Sites>Contacts is not related to safety distribution
What is Principle Investigator?
500
Document Type is PD99
What is Protocol Deviation Form
500
As an ExBP User, there are two options via the ExBP Landing Page to gain access to eTMF.
What is Direct Access and Smart Web?
500
Safety document distribution notification emails that are not delivered.
What is Transmission Failures?
500
Name four contacts in CTMS that is any person involved in the clinical trial who is not part of the study team?
What is
Investigator
Site Personnel (non-investigator) like study nurse, pharmacist, site coordinator…
Central Laboratory Personnel
EC/IRB Personnel
Health Authority Personnel
Other Service Provider Personnel