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Search results with tag "Causality assessment"
Revised AEFI Guidelines: Executive Summary
main.mohfw.gov.inCausality Assessment is the systematic evaluation of the information obtained about an AEFI to determine the likelihood of the event having been caused by the vaccine/s received. It is a critical part of AEFI monitoring and enhances confidence in the national immunization programme. The revised guidelines use the new revised WHO/CIOMS Causality ...
5.3.6 CUMULATIVE ANALYSIS OF POST …
drtrozzi.orgreported from clinical studies regardless of causality assessment. The limitations of post-marketing adverse drug event reporting should be considered when interpreting these data: • Reports are submitted voluntarily, and the magnitude of underreporting is unknown.