Background

Research data management for field studies in rural Africa poses unique challenges. Data management in the Pneumococcal Vaccine Schedules (PVS) trial in The Gambia uses the following innovative procedures to maintain data integrity and validity with large numbers of observations where there is no electricity or internet.

Methods

•Confirming residential status and identity of infants in the study area in a continuously updated live sampling frame of over 10,000 births per year.

•User prompts and decision rules for group allocation for over 10,000 births per year and correct vaccine administration according to village of residence for over 50,000 PCV doses per year.

•Weekly synchronisation of data to a central server (up to 400 trial enrolments, 2500 PCV doses and 800 clinical presentations per week monitoring residence of 300,000 population).

•Weekly update of a back-end relational database combining variables from five different applications.

•Linkage of demographic identity details to patients presenting to health facilities using family geneology and photographs.

•Remote data viewing for off-site external trial monitoring, query and resolution audit trail, as well as trial staff real-time viewing of data.

Results

Interactive experience of the data systems will be available at the conference.

Conclusions

Those systems are working properly for PVS data collection.