Welcome to the Quiz on Pharmacovigilance

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Following are the negative criteria for selecting a signal:
CIOMS stands for___________.
As per WHO definitions, A clinical event, including a laboratory test abnormality, with a reasonable time sequence to administration of the drug but which could also be explained by concurrent disease or other drugs or chemicals is known as_______________.
A rapid increase in reporting regulatory intervention (prevention) is advised when:
The process of electronically receiving a case within Argus Safety after it has been physically received by the Drug Safety team is called:
Epidemiological investigations focus on
Individual case reports of adverse drug reactions & adverse event should be transmitted from
Each SUSAR report is identified by which of the following?
Ad hoc studies are analyses of
The scope of the SOP does not need to clearly state that it applies to adverse events that occur at sites/organisation/institution:
According to Schedule-Y, sponsor should report SAE to - Regulatory Authorities as well as to all Investigators participating in trial within:
The PSUR usually include:
Any untoward medical occurrence n a patient or clinical trial subject administered a pharmaceutical product and which does not necessarily have to have a causal relation with this treatment is known as
A mathematical model to assess many factors is
Signal Documents are automatically reassessed:
Regulatory reporting for multiple case reports over a specified time period is termed as:
Accidental intravenous injection of __________ can lead to fatal cardiac arrhythmias.
During the generation and development of safety data and risk minimization action plans, the following is of importance:
ADRs in Clinical Trials can be detected by :
Bias is a: