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.

This course runs in Semester 1 and is made up of lectures and tutorials.

None

None

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]. 

It is the default expectation that all courses will offer opportunities for reassessment or deferred assessment. Where it is not possible to offer this in some assessment components, the grade achieved at the first attempt will be counted towards the final course grade, and any exceptions for this course are described below.

[No exceptions]

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.

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.