This course examines the fundamentals of clinical trials, exploring the various trial types and how to design them. Students will examine key methodologies, Patient-Participant Involvement and engagement (PPIe), Good Clinical Practice (GCP), financial considerations and regulatory frameworks involved in clinical trials.

This course runs in Semester 1 and will be delivered face to face on campus.

None

None

1. Individual written report (1500-2000 words, 50%) [ILO1, ILO2].

2. Groupwork output (20 mins, 25%) [ILO3, ILO4].

3. Groupwork output - individual contribution (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 types of clinical trials, how to design trials, and phase of trials.

■ To give students knowledge and understanding of the processes of patient involvement in clinical trial design.

■ To allow students to gain critical and technical skills to evaluate clinical trial design.

■ To provide students with knowledge and understanding of the importance of engaging with multiple stakeholders.

By the end of this course students will be able to:

1. Critically evaluate the principles and design of clinical trials in life sciences.

2. Investigate and critically appraise clinical trial types in life sciences.

3. Critically assess the key requirements of PPIe in clinical trial design.

4. Develop an action plan suitable for a PPIe committee.