Ethics Committee Quality Indicator

 

QI N	QI Name	Formula	Unit of Measurement
Ethics committee
1	Percentage of Research activities approved by Ethics Committee	Number of research activities approved by ethics committee     X 100 Number of research protocols submitted to ethics committee	Percentage
2	Percentage of patients withdrawing from the study	Number of patients who have withdrawn from all ongoing studies  X 100 Number of patients enrolled in all on-going studies	Percentage
3	Percentage of protocol violations/ deviations reported	Number of protocol violations/ deviations reported                  X 100 Number of protocol violations/deviations that have occurred	Percentage
4	Percentage of serious adverse events (which have occurred in the organisation) reported to the ethics committee within the defined timeframe.	Number of serious adverse events reported within the defined timeframe     X 100 Number of serious adverse events reported within and outside the defined timeframe	Percentage