MDCS41940 Clinical Trial Management

Academic Year 2023/2024

This module is part of the graduate programme in clinical and translational research. Building on the theoretical framework already established, this module introduces students to practical aspects of clinical trials and their management. In particular this module seeks to provide students with the clinical and research context in which trials are completed. Students will recieve core instruction in regulatory and ethical aspects of clinical research, will complete GCP trianing and will be provided with an opportunity to intern with clinical research teams.

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Curricular information is subject to change

Learning Outcomes:

On completing this activity, students will be expected to be able to participate effectively in any real life professional learning experience by integrating into research team and apply their academic experience and their theoretical knowledge in a professional research setting.
specifically students will:
Understand clinical trial management (including budgets and costing, project management and risk management)
Understand study start up and monitoring
Understand Regulatory and Quality Systems
Understand core principles of project and time management
Students will be able to review a clinical protocol

Indicative Module Content:

In this module, students will focus on content in ethical legal and social issues in clinical research and will also consider some case studies.

Student Effort Hours: 
Student Effort Type Hours
Lectures

20
Practical

20
Specified Learning Activities

42
Autonomous Student Learning

64
Placement/Work Experience

60
Total

206
Approaches to Teaching and Learning:
active/task-based learning;
group work;
lectures;
critical writing;
case-based learning;
student presentations, 
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
Assignment: Assignment Unspecified n/a Graded No

50
Assignment: Protocol Review Coursework (End of Trimester) n/a Standard conversion grade scale 40% No

50

Carry forward of passed components
Yes
 
Remediation Type Remediation Timing
Repeat Within Two Trimesters
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, on an activity or draft prior to summative assessment
• Peer review activities
• Self-assessment activities

How will my Feedback be Delivered?

Students receive feedback through class discussions, in class quizzes

Name Role
Dr Marie Galligan Tutor
Timetabling information is displayed only for guidance purposes, relates to the current Academic Year only and is subject to change.
 
Spring
      
Lecture Offering 1 Week(s) - 21 Tues 09:00 - 13:50
Lecture Offering 1 Week(s) - 23 Tues 09:00 - 13:50
Lecture Offering 1 Week(s) - 27 Tues 09:00 - 15:50
Lecture Offering 1 Week(s) - 21 Tues 14:00 - 15:50
Lecture Offering 1 Week(s) - 23 Tues 14:00 - 15:50
Lecture Offering 1 Week(s) - 32 Wed 09:00 - 11:50
Lecture Offering 1 Week(s) - 28 Wed 10:00 - 14:50
Lecture Offering 1 Week(s) - 32 Wed 12:00 - 14:50
Spring