A rapid increase in reporting regulatory intervention (prevention) is advised when:

Each SUSAR report is identified by which of the following?

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

Ad hoc studies are analyses of

Following are the negative criteria for selecting a signal:

During the generation and development of safety data and risk minimization action plans, the following is of importance:

Signal Documents are automatically reassessed:

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 mathematical model to assess many factors is

The PSUR usually include:

Epidemiological investigations focus on

Accidental intravenous injection of __________ can lead to fatal cardiac arrhythmias.

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:

Bias is a:

CIOMS stands for___________.

The process of electronically receiving a case within Argus Safety after it has been physically received by the Drug Safety team is called:

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: