At the end of this training course you will have an understanding of the fundamental requirements of conducting research studies according to principals of ICH GCP.
Intended learning objectives:
- Understand and apply the principles of ICH GCP (GCP)
- Understand the purpose and conduct of clinical research studies. (Intro to Clinical Research)
- Understand the processes for obtaining ethical and regulatory approvals for human research studies and drug trials in Australia
- Understand and apply the principles of obtaining and documenting participant informed consent. (Informed Consent)
- Understand, identify and track essential documents required throughout the conduct of a research study (Essential Documents)
- Understand the principles of monitoring activities, identify the different methods of monitoring and apply a risk-based approach to performing monitoring tasks. (Monitoring)
- Create appropriate tracking tools to assist in the management and oversight of clinical research studies. (Setting up and maintaining trackers)
- Improve communication skills required to effectively perform tasks and oversee activities during the conduct of clinical research studies. (Effective Communication)
- Initiate, organize, conduct and appropriately minute meetings required for the oversight and conduct of clinical research (Meeting Management)
- Apply principles of time management to enhance productivity. (Time Management)
- Develop skills to engage effectively with stakeholders to deliver study outcomes. (Influencing People)