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Regulatory affairs, good clinical practice and ethics

Module information>

Academic Direction
London School of Hygiene & Tropical Medicine
Modes of Study

This module seeks to develop your understanding of the key features relating to the regulatory legislation and associated approvals and permissions required to conduct high quality, national and international clinical trials.It is an option for all students on the MSc Clinical Trials, PG Diploma Clinical Trials, MSc Epidemiology, PG Diploma/MSc Global Health Policy.


15 [150 hours]


Formal assessment of the module will be by an Assessed Assignment (20%) and by an 2hr 15 unseen written examination (80%).

If you fail the module overall, you are allowed one further attempt at the failed element (examination and/or assignment).

For full information regarding this module please see the module specification.