How to Conduct and Monitor a Clinical Trial BIOL5454

• Academic Session: 2024-25
• School: MVLS College Services
• Credits: 20
• Level: Level 5 (SCQF level 11)
• Typically Offered: Semester 1
• Available to Visiting Students: 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.

Excluded Courses

None

Co-requisites

None

Assessment

Assessment will consist of:

1. Individual written assignment (1500-2000 words, 50%) [ILO1, ILO2].
2. Group presentation - (20 minutes, 50%) (25% of grade will be based on individual performance and 25% of grade will be based on group performance) [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.

Minimum Requirement for Award of Credits

Students must submit at least 75% by weight of the components (including examinations) of the course’s summative assessment.