Open AccessStrategies for ensuring quality data from Indian investigational sites
Author(s) -
Antal K Hajos,
Sujal K Kamble
Publication year - 2011
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/2229-3485.80367
Subject(s) - quality (philosophy) , pdca , clinical trial , protocol (science) , process management , risk analysis (engineering) , plan (archaeology) , order (exchange) , data quality , business , computer science , quality management , medicine , operations management , alternative medicine , marketing , engineering , service (business) , finance , pathology , philosophy , archaeology , epistemology , history
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.