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- W2108642691 abstract "The primary objective of clinical datamanagement (CDM) is to provide high-quality, reliable data for reporting ran-domized controlled trials (RCTs) in linewith good clinical practice (GCP) require-ments. For treatment trials of neglectedtropical diseases (NTDs) in endemic coun-tries, CDM systems need to be efficientand affordable. Challenges include poorinfrastructure, license costs associated withGCP-compliant software, and limitedhuman resources to provide the requiredexpertise. We argue that high-qualityCDM for NTDs can be achieved and thatchallenges can be overcome through theuse of readily available open-access tools.The Drugs for Neglected Diseasesinitiative (DNDi) [1,2] sponsors severalRCTs of treatments for visceral leishman-iasis (VL) in eastern Africa, working withregional partners through the Leishmani-asis East Africa Platform (LEAP). Thesetrials are conducted according to GCPstandards to ensure internal and externalvalidity, with CDM conducted by theauthors at the Data Centre (DC) basedat DNDi Africa in Nairobi.Choice of proprietary or open-sourcetools is dependent largely on budget anduser experience, with tools used indepen-dently or in combination. We have beenworking to overcome two main challenges:(1) Telecommunication, in particularwith unstable internet connectivity.An ideal tool for CDM would allowimplementation with or without aninternet connection (online and offlinemodes respectively) and be configuredfor use across multiple remote sites.(2) Automated query generation andresolution to provide an audit trailensuring consistency, rigor, and limit-ed risk of human error.We describe our development of two newtools for CDM: an offline module forOpenClinicausersandaquerymanagementsystem (QMS) that allows automation andstandardization of query management withmultiple-user access." @default.
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- W2108642691 date "2014-09-11" @default.
- W2108642691 modified "2023-09-27" @default.
- W2108642691 title "Innovative Approaches to Clinical Data Management in Resource Limited Settings Using Open-Source Technologies" @default.
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- W2108642691 doi "https://doi.org/10.1371/journal.pntd.0003134" @default.
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