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Implementation of good clinical practice in clinical research in the context of limited resources settings: Lessons learnt from the freeBILy trial using an embedded mixed methods approach.

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Title: Implementation of good clinical practice in clinical research in the context of limited resources settings: Lessons learnt from the freeBILy trial using an embedded mixed methods approach.
Authors: Gunga L; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany., Rausche P; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany., Rakotoarivelo RA; Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar., Rasamoelina M; Centre Infectiolologie Charles Mérieux (CICM), Antananarivo, Madagascar., Solonirina J; University Antananarivo, Antananarivo, Madagascar., Fesia E; Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar., Razafindrakoto R; Centre Infectiolologie Charles Mérieux (CICM), Antananarivo, Madagascar., Rakotozandrindrainy N; University Antananarivo, Antananarivo, Madagascar., Radomanana M; Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar., Marchese V; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany., Issa N; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany., Kutz JM; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany., Remkes A; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany., Jager A; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.; Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany., Puraduredja DI; Interdisciplinary Academy of Competence and Education for Global Health (iACE), Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany., van Dam G; Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands., Schwarz N; Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany., May J; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.; Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany., Rakotozandrindrainy R; University Antananarivo, Antananarivo, Madagascar., Fischer N; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany., Fusco D; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.
Corporate Authors: freeBILy consortium
Source: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2026 Feb 09; Vol. 20 (2), pp. e0013899. Date of Electronic Publication: 2026 Feb 09 (Print Publication: 2026).
Publication Type: Journal Article
Journal Info: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488 Publication Model: eCollection Cited Medium: Internet ISSN: 1935-2735 (Electronic) Linking ISSN: 19352727 NLM ISO Abbreviation: PLoS Negl Trop Dis Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Implementation of good clinical practice in clinical research in the context of limited resources settings: Lessons learnt from the freeBILy trial using an embedded mixed methods approach.
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  Data: <searchLink fieldCode="AU" term="%22Gunga+L%22">Gunga L</searchLink>; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Rausche+P%22">Rausche P</searchLink>; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Rakotoarivelo+RA%22">Rakotoarivelo RA</searchLink>; Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar.<br /><searchLink fieldCode="AU" term="%22Rasamoelina+M%22">Rasamoelina M</searchLink>; Centre Infectiolologie Charles Mérieux (CICM), Antananarivo, Madagascar.<br /><searchLink fieldCode="AU" term="%22Solonirina+J%22">Solonirina J</searchLink>; University Antananarivo, Antananarivo, Madagascar.<br /><searchLink fieldCode="AU" term="%22Fesia+E%22">Fesia E</searchLink>; Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar.<br /><searchLink fieldCode="AU" term="%22Razafindrakoto+R%22">Razafindrakoto R</searchLink>; Centre Infectiolologie Charles Mérieux (CICM), Antananarivo, Madagascar.<br /><searchLink fieldCode="AU" term="%22Rakotozandrindrainy+N%22">Rakotozandrindrainy N</searchLink>; University Antananarivo, Antananarivo, Madagascar.<br /><searchLink fieldCode="AU" term="%22Radomanana+M%22">Radomanana M</searchLink>; Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar.<br /><searchLink fieldCode="AU" term="%22Marchese+V%22">Marchese V</searchLink>; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Issa+N%22">Issa N</searchLink>; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Kutz+JM%22">Kutz JM</searchLink>; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Remkes+A%22">Remkes A</searchLink>; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Jager+A%22">Jager A</searchLink>; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.; Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Puraduredja+DI%22">Puraduredja DI</searchLink>; Interdisciplinary Academy of Competence and Education for Global Health (iACE), Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22van+Dam+G%22">van Dam G</searchLink>; Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Schwarz+N%22">Schwarz N</searchLink>; Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22May+J%22">May J</searchLink>; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.; Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Rakotozandrindrainy+R%22">Rakotozandrindrainy R</searchLink>; University Antananarivo, Antananarivo, Madagascar.<br /><searchLink fieldCode="AU" term="%22Fischer+N%22">Fischer N</searchLink>; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.<br /><searchLink fieldCode="AU" term="%22Fusco+D%22">Fusco D</searchLink>; RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany.; German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany.
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