Good Clinical Practice (3 credits)

MQF7009: Good Clinical Practice (3 credits)

Learning Outcomes:
At the end of the course, students are able to:
1. Apply the principles of Good Clinical Practice in Clinical Trial.
2. Examine clinical trials that involve the participation of human subjects.
3. Solve ethical problems in Clinical Trials to ensure study subjects’ wellbeing are safeguarded.

Synopsis:
This course teaches international and local ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. It will include ethical and regulatory issues related to the conduct of clinical trials such as responsibilities of investigators, safety monitoring and reporting, legal issues in clinical trials, audit and inspections. Besides, Good Clinical Practice, other relevant practice guidelines such as Good Laboratory Practice, Good Manufacturing Practice, Good Statistical Practice will be covered.

Assessment Weightage:
Continuous Assessment: 100%
Final Examination: -