London School of Hygiene & Tropical Medicine

This module seeks to develop 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. Students will gain a solid understanding of Good Clinical Practice and will explore ways of implementing Good Clinical Practice, 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 gain an understanding of how important events and legislation have impacted upon 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.

The overall module aim is to equip students with the skills and knowledge needed to work with guidelines and regulations governing clinical trial conduct. It will require students to engage with and apply the ethical principles underpinning those regulations.

Intended learning outcomes

Upon successful completion of the module a student will be able to: 

1. Explain the role of regulatory affairs in the development of new medicines.
2. Apply the principles of Good Clinical Practice.
3. Apply the ethical principles underpinning regulatory affairs.

Assessment

The assessment strategy for the Regulatory Affairs, Good Clinical Practice and Ethics module includes:

• A 2,000 words Assessed Assignment (60%).
• A 2,000 words Time Limited Assessment (40%).

Mode of delivery

Our distance learning modules are delivered entirely online via directed self-study and online materials via the Virtual Learning Environment.

Module duration

Distance learning module studies begin at the start of October each year. Students may start their studies at any time once they gain access to Moodle (the virtual learning environment) and study materials, and work through the materials in line with the assessment schedules. The study year runs from the beginning of October through to June examinations. Some students also study between June and September with extended tutorial support (e.g. those undertaking projects, the Clinical Trials integrating report, or two of the Epidemiology modules). Deadlines for submission of coursework vary per programme but are usually in February, March, May, and September.

How you'll study

Our distance learning programmes are predominantly online and largely self-directed study to enable you to study independently and at times convenient to you. You'll have access to tutorial support and the ability to interact with other students and form study groups throughout the study year via the discussions in our Virtual Learning Environment, Moodle.

Credits

• CATS: 15
• ECTS: 7.5

Module specification

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

Please note: information based on the 2025-26 module specification subject to change for 2026-27 entry.