Introduction to Clinical Trial Types and Design BIOL5455

• 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 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.

Timetable

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

Excluded Courses

None

Co-requisites

None

Assessment

Assessment will consist of:

1. Individual written report (1500-2000 words, 50%) [ILO1, ILO2].
2. Group work output (20 mins, 50%) (25% of the grade will be based on individual performance and 25% of the 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 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.

Intended Learning Outcomes of Course

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.

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.