Standard operating procedures (SOPS) for health and demographic research data quality assurance: the case of VADU HDSS site

Twumasi, Mieks Frenken Nyarko
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The idea of data quality assurance and security control is to monitor the quality of research data generated from any research activity. This consists of a thorough collection of documentation regarding all aspects of the research. Data management procedures of health and demographic research constantly changes or emerges through the iterative processes of data collection and analysis and requires that the investigator make frequent decisions that can alter the course of the study. As a result, audit trails that provides justification for these actions will be vital for future analysis. The audit trail provides a mechanism for retroactive assessment of the conduct of the inquiry and a means to address issues related to authenticity of the research datasets. This research seeks to develop an Information Assurance Policy and Standard Operating Procedures for Vadu Health and Demographic Surveillance System Site using ISACA/COBIT 5 family products and ISO/IEC ISMS as benchmark. The work proposes data assurance and security controls and measures for any given research project. To develop such SOP, there is a need to identify existing gaps and inconsistencies within the data management life cycle at VRHP site. This will allow us to establish the areas of focus for the SOP. We used an interview-based approach to identify the existing gaps associated with data management life cycle at VRHP site. The study population included key members of the data management team. The study was conducted utilizing a self-administered questionnaire with structured and open ended questions. Purposive sampling method used to enrol 21 data management team members consisting of 13 Field Research Assistants, 4 Field Research Supervisors, 1 Field Coordinator, 1 Software Application Developer, 1 Head of Data Management and 1 Data Manager. Unstructured interviews were conducted to gather information on respective roles and responsibilities of the members to ensure maximum open interactions. Data gathering and analyses were done concurrently. Two themes arose from the data: Current lapses in data collection at Vadu HDSS and current lapses in data management at Vadu HDSS. The response rate was 95.5%. We adopted the ISACA/COBIT 5 guidelines and ISO/IEC ISMS as benchmark to develop SOPs to guide data management life cycle activities in enforcing data quality assurance. We also included some guidelines that can be used in replicating the SOP at other research institution.
A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand in partial fulfilment of the requirements for the degree of Masters of Science In Epidemiology (Research Data Management) Johannesburg, September 2016