Module 1: Drug Development Process [30hrs]
This module provides a detailed overview of the drug development process. The students will learn in a step-by-step approach each stage of drug development, starting from the discovery of a new chemical entity through pre-clinical safety, efficacy and toxicology testing, the route to clinical testing and phases of clinical trials, to market launch and post marketing surveillance.
Module 2: Medical, Ethical and Legal Aspects of Clinical Trials [30hrs]
This module provides students with an understanding of the fundamental medical, legal and ethical issues relating to clinical research. Students will learn to interpret and apply the ethical principles in an appropriate manner to protect the rights and welfare of human research participants.
Module 3: Research Methodology and Statistical Concepts in Clinical Trials [30hrs]
This module introduces students to research methodology and biostatistics in clinical research. It covers an overview of research concepts, literature review, quantitative and qualitative research designs, data collection, analysis and interpretation techniques.
Module 4: Clinical Trial Project [30hrs]
This module provides the students with the opportunity to apply the principles of scientific inquiry, research design, sampling techniques, data collection and ethics in clinical research.