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Importance of quality in clinical data management

Quality is the degree to which a set of inherent characteristics fulfils requirements. In clinical data management, quality is the critical element with an expected minimum accuracy rate of 99.95% and is assessed at all stages from double data entry till study lock. The implication of poor quality is the delay in drug development and launch to the market resulting in huge loss to the pharmaceutical companies. This study gives an outline of the quality issues with quality ways implemented for clinical data management based on ongoing quality checks focused on probability of error estimation and error reduction with quality results. The quality checks also pave the way to quality and process improvements.