Data management system for community-based randomized controlled trial in India
Goudar, S. S., Brinkley, M. F., Forvendel, D. G., Singh, A. P., Revankar, A. P., Kodkany, B. S., & Derman, R. J. (2005, February). Data management system for community-based randomized controlled trial in India. Presented at Indian Conference on Medical Informatics and Telemedicine - ICMIT 2005, Karagpur, India.
Electronic data management systems offer unique advantages over paper based data collection systems, especially for implementing and monitoringcommunity based research projects. Until recently, data collection in the health sector in rural India has primarily been paper-based. Ensuring data quality is critical for obtaining meaningful inferences from such studies. An electronic Data Management System has been successfully developed and used for an ongoing Global Network for Women’s and Children’s Health Research community-based randomized controlled trial in rural India. The system incorporates features such as edit and range checks, between and within form consistency checks, double key verification and an audit trail log for capturing valid and reliable data. Reports are generated to monitor and evaluate progress of the study and to provide feedback to field staff to improve enrolment of study participants, ensure data quality and achieve compliance in data collection at multiple time points prescribed in the study protocol. Limited computing skills of study personnel and difficulties in executing a distributed data entry system were the major barriers in implementation. Erratic power supply and poor quality telephone connectivity necessitated a switch from distributed to centralized data entry. Training of personnel and use of wireless technology may overcome these barriers.