Regulatory Affairs, GCP and Ethics (CTM204)
Aims
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.
Integral to the legislation is Good Clinical Practice (GCP). Students will gain a solid understanding of GCP and will explore ways of implementing GCP, including risk assessment and trial monitoring. Although the focus will be on
trials of medicinal products, trials in a variety of other areas, and in different geographical settings, will be examined. Ethical issues will be considered throughout the module. Students will review the history of ethics to get an understanding of how important events and legislation have impacted on and shaped how clinical trials are conducted today. This module consolidates and develops many of the topics introduced in the core module CTM103 Clinical
Trials in Practice.
Credits
15 credits are offered on successful completion of this module.
Prerequisites and Selection
Those wishing to study this module should have regular access to the internet to benefit from library facilities, participate in web-based conference discussions and submit assignments.
Students who do not have a background in clinical trials may need to spend some time familiarising themselves with terminology before they can successfully complete this module. Please see the Module Outline for more details.
Students must meet the required standard of English required to study this course. Details can be found here.
Fee
The tuition fee for this module is £1,655.
Module Outline
A full outline of the module can be downloaded here as a PDF.
