MDCS41640 Clinical Trials

Academic Year 2021/2022

This module forms part of the graduate programme in clinical and translational research. This module introduces students to drug discovery & development and introduces critical concepts in clinical trial design. In this module students will be introduced to clinical trials, from new drug discovery to how trials of medicines are completed.
Specific areas of focus in this module includes
1) Introduction to Pharmacology
2) New drug discovery
3) Preclinical Testing
4) Clinical Trial Designs
5) Trial Endpoints
6) Trial periods and interventions
7) Trial populations
8) Phases of Trials


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Curricular information is subject to change

Learning Outcomes:

On completion of this module students will develop a comprehensive understanding of clinical trials, how they are designed and completed.
Specifically, students will be able to:
Understand clinical trial principles, including study design
Understand regulatory and legal environment in which clinical trials are completed
Analyse the design of clinical trials
Understand how emerging technologies are directly enhancing clinical trials
Appreciate how Good Clinical Practice guides trial design, development and implementation




Indicative Module Content:

This modules includes content on the following key areas
1) Drug Discovery and Development
2) Clinical Trial Designs
3) Clinical Trial Applications

Student Effort Hours: 
Student Effort Type Hours
Lectures

57
Seminar (or Webinar)

11
Specified Learning Activities

42
Autonomous Student Learning

90
Total

200
Approaches to Teaching and Learning:
Lectures
Online lectures of clinical trials in focus
Additional reading 
Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Not applicable to this module.
 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Examination: Exam 2 hour End of Trimester Exam No Graded Yes

100

Carry forward of passed components
Yes
 
Resit In Terminal Exam
Spring Yes - 2 Hour
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Group/class feedback, post-assessment

How will my Feedback be Delivered?

Feedback provided at end of assessment In class instant feedback by way of quizzes

Name Role
Dr Marie Galligan Lecturer / Co-Lecturer