Fundamentals of Clinical Research (Sep, 2015)

This two-day course provides you with the core knowledge and practical insight you need to execute your functions more effectively and efficiently. Fundamentals of Clinical Research offers an introduction to clinical research and covers: ethical concerns and human subject protection; regulatory obligations; essential documents, including research records; clinical trials start up and conduct; quality control, focusing on the monitoring of clinical trials; adverse experiences; and subject recruitment. This interactive classroom course includes question-and-answer sessions, interactive classroom exercises, a participants’ manual and presentations delivered by experienced experts in clinical research.

Objectives:

By the end of the course you should be able to:

- Discuss the main historical events which led to the increasing regulation of the development of pharmaceutical products, devices and biologics;
- Explain the differences in the development processes for pharmaceutical products, devices and biologics;
- Identify the roles and responsibilities of clinical research professionals in the overall process of conducting a clinical trial, and how each professional contributes to that process;
- Apply the principles of Good Clinical Practice (GCP) in their daily functions; and
- Identify the main regulations which govern the practice of clinical research.