How to Conduct and Monitor a Clinical Trial BIOL5454
- Academic Session: 2026-27
- School: MVLS College Services
- Credits: 20
- Level: Level 5 (SCQF level 11)
- Typically Offered: Semester 1
- Available to Visiting Students: No
- Collaborative Online International Learning: No
- Curriculum For Life: No
Short Description
This course will cover how to conduct and monitor a clinical trial. Students will learn about key trial documents and procedures. In addition, they will learn how to monitor a trial, troubleshoot when the trial is in progress and finally how to report trial results.
Timetable
This course runs in Semester 1 and is made up of lectures and tutorials.
Requirements of Entry
None
Excluded Courses
None
Co-requisites
None
Assessment
1. Individual written assignment (1500-2000 words, 50%) [ILO1, ILO2].
2. Group presentation - (20 minutes, 25%) [ILO3, ILO4].
3. Group presentation - individual contribution to group (25%) [ILO3, ILO4].
Course Aims
The specific aims of this taught course are:
■ To provide students with comprehensive knowledge of how to conduct and monitor a clinical trial.
■ To give students the training and knowledge to design their own clinical trial standard operating procedure.
■ To introduce students to the key clinical trial procedures that must be adhered to when conducting and amending a clinical trial.
■ To familiarise students with the procedures that are followed when a clinical trial has finished.
Intended Learning Outcomes of Course
By the end of this course students will be able to:
1. Design a detailed checklist to support the setup, management, and closedown of a clinical trial.
2. Synthesise a lay summary to provides a concise overview of the clinical trial findings for a general audience.
3. Critically evaluate and troubleshoot common clinical trial amendments.
4. Justify appropriate amendments to clinical trial protocols.