Developing Generic Templates to Shape the Future for Conducting Integrated Research Platform Trials
Developing Generic Templates to Shape the Future for Conducting Integrated Research Platform Trials
<title>Abstract</title> <bold>Background:</bold>Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good clinical practice - Scientific guideline, first published in 2002 and last updated in 2016. This document provides an international ethical and scientific quality standard …