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Towards Research Equity – Challenges of Safety Monitoring During Clinical Trials in Resource- Limited Settings

Issue: 
Pages: 
163–5

INTRODUCTION

The safety and wellbeing of the volunteer participant is central to the clinical research process, making Adverse Events (AE) management a core function of clinical trials and Good Clinical Practice (GCP) (1). The ultimate aim is to protect the greater society in its exposure to the products of the clinical research, through clinical research practice and philosophy, by clearly defining the parameters within which the new intervention can and must be used after its licensure by regulatory authorities.

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e-Published: 01 Jul, 2013
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