London School of Hygiene & Tropical Medicine

In this module we discuss the various processes involved in running a clinical trial and how these can be adapted for different trial designs and scenarios.

The module covers the whole life cycle of a clinical trial, including clarifying and operationalising the primary and secondary objectives, the implications of design choices for implementation of a trial, trial governance, approvals (including Regulatory and ethics committee), recruitment and data processing methods. We will also explore quality assurance and control, and investigate both data processing and data management issues.

The overall module aim is to cover the key steps in the logistical and practical implementation of a clinical trial, from inception to dissemination.

Intended learning outcomes

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

1. Critically analyse and formulate strategic project management responses to implementation of trial designs, taking into account logistical, ethical and regulatory constraints.
2. Demonstrate understanding of how to plan and set up a research project so that quality and standards are promoted and maintained.
3. Critically evaluate and use efficient and responsive project management techniques in the conduct of clinical trials.
4. Demonstrate understanding of how data management contributes to the success of a clinical trial.
5. Select and use methods for reporting trial results as appropriate for different audiences.

Assessment

This module assessment includes a 4,000 words Assessed Assignment.

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.