Pharmacovigilance Assessment

by | Oct 22, 2018 | 0 comments

Welcome to the Quiz on Pharmacovigilance

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ADRs in Clinical Trials can be detected by :
According to Schedule-Y, sponsor should report SAE to - Regulatory Authorities as well as to all Investigators participating in trial within:
Ad hoc studies are analyses of
Accidental intravenous injection of __________ can lead to fatal cardiac arrhythmias.
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:
The PSUR usually include:
Epidemiological investigations focus on
The scope of the SOP does not need to clearly state that it applies to adverse events that occur at sites/organisation/institution:
During the generation and development of safety data and risk minimization action plans, the following is of importance:
Each SUSAR report is identified by which of the following?
A mathematical model to assess many factors is
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
Following are the negative criteria for selecting a signal:
Signal Documents are automatically reassessed:
Bias is a:
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_______________.
CIOMS stands for___________.
Individual case reports of adverse drug reactions & adverse event should be transmitted from
Regulatory reporting for multiple case reports over a specified time period is termed as:

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