Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.

Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial.

Adverse drug reactions related to the use of non-steroidal anti-inflammatory drugs: results of spontaneous reporting from central India.

To assess the adverse drug reactions to non-steroidal anti-inflammatory drugs through spontaneous reporting system in IGGMC&H, Nagpur and to analyse them using WHO assessment scales, an observational, prospective study was conducted in patients attending outpatient department, inpatient department and casualty of IGGMC and H Nagpur from 1st June 2005 to 31st May 2009. Data were collected by spontaneous adverse drug reactions reporting system. Among 2639 total adverse drug reactions reported, 336 (12.