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
  • Collaborative Online International Learning: 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.

Requirements of Entry

None

Excluded Courses

None

Co-requisites

None

Assessment

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

2. Groupwork output (20 mins, 50%) [ILO3, ILO4].

3. Groupwork output - individual contribution (25%) [ILO3, ILO4].

Are reassessment opportunities available for all summative assessments? No

Reassessments are normally available for all courses, except those which contribute to the Honours classification. Where, exceptionally, reassessment on Honours courses is required to satisfy professional/accreditation requirements, only the overall course grade achieved at the first attempt will contribute to the Honours classification. For non-Honours courses, students are offered reassessment in all or any of the components of assessment if the satisfactory (threshold) grade for the overall course is not achieved at the first attempt. This is normally grade D3 for undergraduate students and grade C3 for postgraduate students. Exceptionally it may not be possible to offer reassessment of some coursework items, in which case the mark achieved at the first attempt will be counted towards the final course grade. Any such exceptions for this course are described below. 

 

Elements of groupwork are not re-assessable.

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.