Strategies for ensuring quality data from Indian investigational sites

Perspectives in Clinical Research

关键词: Clinical monitoring;    clinical trial;    compliance;    data quality;    investigational site;    PDCA;    site management;    site selection;   

DOI  :  10.4103/2229-3485.80367

来源: DOAJ

【 摘 要 】

The topic of ensuring quality and compliance is and must be a top priority in the conduct of clinical trials, as warranted by regulatory guidelines as well as the inherent responsibility of the professionals conducting such research. Fast-growing emerging clinical geographies such as India demand special attention due to rapid growth and associated factors that may put study quality at risk. In this paper, we used the basic principle of PDCA (Plan, Do, Check, and Adjust) to structure the processes of a clinical trial from protocol to final analysis in order to highlight the interactive nature of involved people and processes required to ensure quality of data and site functioning.

【 授权许可】

Unknown