After completing this course, you will be able to:

• Understand the principles of pharmacology, methods of measuring and;
• Describe the types of studies in early clinical development (Phase I and Phase II studies).

After completing this course, you will be able to:

• Describe trial participants' roles and rights and how they are protected.

After completing this course, you will be able to:

• Describe the history of ethics in clinical research and the concepts and values of ethics for research involving humans.
• Explain how ethics evaluations are conducted internationally, nationally and locally.
• Describe the potential roles of patients at each level.

After completing this course, you will be able to:

• Understand the basic concepts and statistical methods used in clinical research.
• Describe the purpose of the statistical analysis plan (SAP).

After completing this course, you will be able to:

• Describe types of data and the principles of data collecting and management in clinical trials.
• Outline the principles and key elements of overall clinical trial quality management and the stakeholders involved.

After completing this course, you will be able to:

• Describe the elements of clinical trial results including how to avoid bias, fraud, misconduct and ethics violations during trial and reporting of results.
• Describe how to perform critically reading.