CTMG6005 - Regulatory, Legal and Ethical Issues of Clinical Trials

This course is part of our Post-Degree Diploma in Clinical Trials Management.

Explore the ethical issues of clinical trials, including ethics review boards, current national and international standards and guidelines, legal principles and issues related to informed consent, liability, and regulatory and legal issues related to clinical trials.

Topics

The history of the regulations in clinical trials
The principles of Good Clinical Practice Guidelines and International Clinical Conference on Harmonization
Health Canada and FDA guidelines
Ethical and legal requirements for clinical trials

Diploma Program Progression

Successful completion of first term courses (Minimum 70% average with no single final grade below 65%) is required for progression to second term courses. Successful completion of first and second term courses is required for progression to practicum.