Introduction

Welcome. You're probably looking at these modules because you are involved in the conduct, management and research side of clinical trials or have an interest in doing so, right? Well, this programme aims to describe the process and give you a clear understanding of what you need to do to get it right. Whether you're in the thick of the research itself, working in a research office or wanting to find out more about clinical trials that are conducted in Australia, these modules will help you to understand how the trials take place in Australia, promote responsible research practices, ensure quality research outcomes and make sure participant safety is maintained at all times.

This module will give you a good overview of how clinical trials work in Australia. A second module will cover research ethics and how to manage the process of an ethics review. A third and final module will cover research governance and how to make sure you understand all the checks and clearances that are necessary to start your research project or how you can help someone get their research off the ground.

NHMRC has made these modules to help maintain Australia's reputation as a great place to conduct quality, clinical research. It's a good idea to complete all modules. And I'd recommend doing them in sequence. But if you have a particular interest in either of the other two it's up to you which order you do them in.

Before we begin, it might be useful to look at our tips for navigating this programme. If you haven't already done so, please click on help on the top, right hand corner for a quick tutorial. The help desk will be available at all times just in case you lose your way. Let's get to it.

I've invited some leading researchers who have been involved in conducting clinical trials to tell us about the key steps in clinical trials and the regulatory environment. And what we need to do to comply with the system, rules, regulations and policies. Once you understand these, you'll have a good overview of the process so you'll be able to plan ahead and know where to go for help. Understanding the clinical trials environment will help you plan ahead.

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