Data management and quality assurance for an International project: the Indo-US Cross-National Dementia Epidemiology...

Data management and quality assurance play a vital but often neglected role in ensuring high quality research, particularly in collaborative and international studies.

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.

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.

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.