Abstract

Researchers and non-commercial institutions negotiate complex legislation and guidance when planning and conducting research studies. The documents and processes required differ across nations and their regulatory bodies and it can be challenging to conduct an international study, especially for non-commercial organisations. In this study, colleagues from Japan and the UK worked closely together focusing on the legislation, organisations, trial processes, ethics review and quality assurance frameworks of clinical trials in two countries, the UK, demonstrated on the model of practices in the University of Bristol and University Hospital Bristol NHS Foundation Trust, and Japan, based on the model in Kyoto University Hospital. Although the ICH tripartite guidelines were developed with participation from both the EU and Japan the set-up and approval processes for clinical trials are different between the two countries while the expectations for quality assurance are similar. We will argue that the f...