title: Monitoring clinical trials: a practical guide.
abstract: This article describes the processes and procedures involved in planning, conducting and reporting monitoring activities for large Clinical Trials of Investigational Medicinal Products (CTIMPs), focusing on those conducted in resource-limited settings.
authors.affiliation: St George's, University of London, Institute for Infection and Immunity, London, UK.
authors.forename: Síle F
authors.initials: SF
authors.lastname: Molloy
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Patricia
authors.initials: P
authors.lastname: Henley
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D026724:Ethical Review; D006295:Health Resources; D006801:Humans; D017410:Practice Guidelines as Topic
keywords: Buenas Prácticas Clínicas; Good Clinical Practice; bonnes pratiques cliniques; clinical trial; ensayo clínico; essai clinique; lugar con recursos limitados; monitoreo basado en los riesgos; monitoring; monitorización; resource-limited setting; risk-based monitoring; régions à ressources limitées; suivi; surveillance basée sur les risques