Building a Centre of Excellence in Data Management in East Africa

Background: In resource-limited settings, there is a paucity of high quality data management systems for clinical research. The result is that data are often managed in high-income countries disadvantaging researchers at sites where the data are collected. An institutional data management system to address the data collection concerns of the collaborators and sponsors is a key institutional capacity element for high quality research. Our goal was to build a local data management center to streamline data collection and validation compliant with international regulatory bodies. Methods: Leveraging established collaborations between Office of Cyber Infrastructure and Computational Biology of the National Institutes of Health and the John Hopkins University School of Medicine in the United States, the Infectious Diseases Institute at Makerere University built a data management coordinating center. This included mentorship from the NIAID International Centers for Excellence in Research and training of key personnel in South Africa at a functioning data center. The number of studies, case report forms processed and the number of publications emanating from studies using the data management unit since its inception were tabulated. Results: The Infectious Diseases Institute data management core began processing data in 2009 with 3 personnel, hardware (network-enabled scanners, desktops, server held in Bethesda with nightly back up) and software licenses, in addition to on-site support from the NIH. In the last 10 years, 850,869 pages of data have been processed from 60 studies in Uganda, across sub-Saharan Africa, Asia and South America. Real-time data cleaning and data analysis occur routinely and enhance clinical research quality; a total of 212 publications from IDI investigators have been published over the past 10 years. Apart from the server back-up services provided by the NIH, the center is now self-sustaining from fees charged to individual studies. Conclusion: Collaborative partnership among research institutions enabled the IDI to build a core data management and coordination center to support clinical studies, build institutional research capacity, and to advance data quality and integrity for the investigators and sponsors.