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. 2016 Dec;21(12):1602-1611.
doi: 10.1111/tmi.12781. Epub 2016 Oct 17.

Monitoring clinical trials: a practical guide

Síle F Molloy  1 , Patricia Henley  2
Affiliations
Free article

Monitoring clinical trials: a practical guide

Síle F Molloy et al. Trop Med Int Health. 2016 Dec.
Free article

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.

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.

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