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
  • Collaborative Online International Learning: 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.

Requirements of Entry

None

Excluded Courses

None

Co-requisites

None

Assessment

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]. 

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 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.