Po 8471 a Survey of Current Clinical Data Management Practices in Sub-Saharan Africa

Abstract

BackgroundInformation on clinical data management (CDM) practices in clinical trials in sub-Saharan Africa is scarce. As part of ALERRT (the African coalition for Epidemic Research, Response and Training, an EDCTP-funded project) we want to gauge current CDM and ICT practices and identify possible gaps within different research institutions in sub-Saharan Africa. This information will be used to develop a scalable, GCP-compliant, robust CDM/ICT infrastructure suitable for resource-poor settings and response-ready in the event of an outbreak.MethodsAn online survey was designed to assess the experience of the participating sites with the various CDM processes, CDM documentation and facilities, the availability of dedicated staff and their experience with GCP. In addition, ICT features essential to CDM will be assessed. Lastly, information on the use of CDM software will be obtained. Respondents can request to receive personalised feedback (aimed to improve their CDM practices) based on their results. The survey, in English and French, will be sent out to 100 sites in sub-Saharan Africa. Sites with intermittent internet connections will receive an MS-Office Word-version of the survey.ResultsThe survey will be closed after a month. Personalised feedback (if requested) will be sent to the respondents. Descriptive analysis of the survey results will be done, and results will be used to design standard data management tools, tailored to the needs of research sites in sub-Saharan Africa and suitable for emergency research. Both results and tools will be disseminated to the scientific community.ConclusionThe results of this survey will provide relevant information on the current CDM and ICT practices in sub-Saharan Africa. Potential pitfalls will be identified and opportunities for improvement will be addressed. Furthermore, the survey will offer a chance to exchange ideas between African and European partners on how to implement good CDM and ICT practices.