Over the past few years, regulations governing the conduct of clinical trials have become more and more stringent, placing greater demands on Investigators and study staff alike. To ensure the safety and wellbeing of subjects and patients at all times and the validity of data collected, clinical trials need to be carried out in accordance with national and international standards.
This intensive course teaches the basic principles of clinical research, and gives thorough insight into how clinical trials are conducted in hospitals and doctor’s practices. It also takes an in-depth look at recent developments in the field of clinical research and the latest legal and regulatory guidelines. Through the extensive use of authentic, blinded study documents and task-based learning, participants gain first-hand experience of the tasks required of a Study Nurse or Clinical Research Coordinator.
The very practical nature of the course means that you will be familiar with all standard study documentation and procedures, and be able to perform all the tasks required of you in your daily work. You will obtain an understanding of the regulatory framework and the principles of Good Clinical Practice, both of which govern the conduct of clinical trials today. You will be aware of the roles and responsibilities of all parties involved in a trial, and the importance of accurate reporting and documentation to ensure patient safety and compliance with the study protocol. You will find out exactly what happens at qualification and initiation visits, and what to expect at regular monitoring visits once a study is up and running.