Exam 6 Flashcards
A technology that enables you to convert different types of documents into editable and searchable data is
OCR
After a subject is off-study, newly identified adverse events or serious adverse events can be reported for ____days the end of protocol treatments
30 days
A congenital anomaly/bird defect is an example of _____adverse events or suspected adverse reaction
Serious
AERS is ?
Adverse Event Reporting System
Managing the coordinating center is an essential function of ??
Leas Site staff
Any noxious changes which is suspected to be due to a drug, occurs at doses normally used, required treatment or decrease in dose or indicates caution in the future use of the same drug is ???
Adverse Drug Reaction
For the reportable SAE, the protocol is a timeline within _____from the time the investigator was notified of the event.
24 hr
If the AE continues and the subject is off the study, check the _____box
Continuing AE
DTMF is ?
Dual Tone Multi Frequency signaling
The subject number changes with the subsequent phase of the study
False
Events that meet the definition of Unanticipated problems must be submitted within ____business days of becoming aware of the event
2days
A statistical tool within VIGI search that allows filtering of the results by demographic
IGIMINE
When responsiveness diminishes rapidly after administration of a drug, the response is ?
Tachypylaxis
Risk assessment should be completed ____the protocol
Before
Protection of human subject is 21CFR ___?
50
