Electronic data management for vaccine trials in low resource settings: Upgrades, scalability and impact of ODK

<jats:p>Background ODK provides software and standards that are popular solutions for off-grid electronic data collection and has substantial code overlap and interoperability with a number of related software products including CommCare, Enketo, Ona, SurveyCTO and KoBoToolbox. In combination with the use of statistical analysis software such as R, these tools provide fully open-source options for off-grid use in public health data collection, management, analysis and reporting. During the 2018-2020 Ebola epidemic in the North Kivu &amp; Ituri regions of Democratic Republic of Congo, we leveraged ODK and other tools to support the DRC Minist&amp;egravere de la Sant&amp;eacute RDC and World Health Organization in their efforts to administer an experimental vaccine (VSV-Zebov-GP) as part of their strategy to control the transmission of infection. Method New functions were developed to facilitate the use of ODK, Enketo and R in large scale data collection, aggregation, monitoring and near-real-time analysis during clinical research in health emergencies. We present open-source enhancements to ODK that include a built-in audit-trail, a framework and companion app for biometric registration of ISO/IEC 19794-2 fingerprint templates, enhanced performance features, better scalability for studies featuring millions of data form submissions, increased options for parallelization of research projects, and pipelines for automated management and analysis of data. We also developed novel encryption protocols for enhanced web-form security in Enketo. Results Against the backdrop of a complex and challenging epidemic response, our enhanced platform of open tools was used to collect and manage data from more than 280,000 eligible study participants who received VSV-Zebov-GP under informed consent. These data were used to determine whether the VSV-Zebov-GP was safe and effective and to guide daily field operations. Conclusions We present open-source developments that make electronic data management during clinical research and health emergencies more viable and robust. These developments will also enhance and expand the functionality of a diverse range of data collection platforms (Ona, KoBoToolbox etc.) that are based on the ODK software and standards. Funding This research is funded by the Department of Health and Social Care using UK Aid funding and is managed by the NIHR (PR-OD-1017-20001).</jats:p>