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BMC Research Notes

, 7:845

Medical Informatics and Decision Making

Abstract

BackgroundClinical trials data management CTDM remains one of the many challenges in running state of the art trials in resource-poor settings since most trials do not allocate, or have available, sufficient resources for CTDM and because of poor internet connectivity. Open-source software like OpenClinica could be a solution in such scenarios.

FindingsIn 2007, the KEMRI-Wellcome Trust Research Programme KWTRP adopted OpenClinica OC community edition, an open-source software system and we share our experience and lessons learnt since its adoption. We have used OC in three different modes; direct remote data entry from sites through Global System for Mobile Communications GSM modems, a centralized data centre approach where all data from paper records were entered at a central location and an off-line approach where data entry was done from a copy of database hosted on a field-site server laptop, then data uploaded to a centralized server later. We have used OC in eleven trials-studies with a cumulative number of participants in excess of 6000. These include large and complex trials, with multiple sites recruiting in different regions of East Africa. In the process, we have developed substantial local capacity through hands-on training and mentorship, which we have now begun to share with other institutions in the region.

ConclusionsOur experience demonstrates that an open source data management system to manage trials’ data can be utilized to international industry standards in resource-poor countries.

KeywordsClinical trials Data management Open-source systems OpenClinica AbbreviationsKEMRIKenya Medical Research Institute

KWTRPKEMRI-Wellcome Trust Research Programme

CTDMSClinical trials data management system

OCOpenClinica

CRFCase report form

eCRFElectronic case report form

ICTInformation and communications technology

EDCEletronic Data Capture

CTFClinical Trials Facility

GCPGood clinical practice

UKUnited Kingdom

MRC-CTUMedical Research Council clinical trials unit

EDCTPEuropen and Developing Countries Clinical Trials Partnership

XMLExtensible Markup Language.

Electronic supplementary materialThe online version of this article doi:10.1186-1756-0500-7-845 contains supplementary material, which is available to authorized users.

Moses M Ngari, Naomi Waithira contributed equally to this work.

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Autor: Moses M Ngari - Naomi Waithira - Roma Chilengi - Patricia Njuguna - Trudie Lang - Greg Fegan

Fuente: https://link.springer.com/



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