Health professionals are encouraged to report adverse reactions which they believe to be drug-related directly to –
the regulatory authority or The company marketing the suspected product on a voluntary basis. Data acquisition depends largely on the input of information derived from reports submitted by the health professionals who have encountered what they suspect is an ADR data assessment which involves assessment of the individual case reports and assessment of pooled data obtained from various sources such as the international database of the WHO. Spontaneous Reporting is defined as “A system whereby case reports of adverse drug events are voluntarily submitted by health professionals and pharmaceutical companies to the national pharmacovigilance centre.

Spontaneous Reporting System (SRS)

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