Data management and quality assurance for an international project: The Indo-US Cross-National Dementia Epidemiology Study

Background: Data management and quality assurance play a vital but often neglected role in ensuring high quality research, particularly in collaborative and international studies. Objective: A data management and quality assurance program was set up for a cross-national epidemiological study of Alzheimer's disease, with centers in India and the United States. Methods: The study involved (a) the development of instruments for the assessment of elderly illiterate Hindi-speaking individuals; and (b) the use of those instruments to carry out an epidemiological study in a population-based cohort of over 5000 persons. Responsibility for data management and quality assurance was shared between the two sites. A cooperative system was instituted for forms and edit development, data entry, checking, transmission, and further checking to ensure that quality data were available for timely analysis. A quality control software program (CHECKS) was written expressly for this project to ensure the highest possible level of data integrity. Conclusions: This report addresses issues particularly relevant to data management and quality assurance at developing country sites, and to collaborations between sites in developed and developing countries.