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MDCS41940

Academic Year 2024/2025

Clinical Trial Management (MDCS41940)

Subject:
Medicine Clinical Science
College:
Health & Agricultural Sciences
School:
Medicine
Level:
4 (Masters)
Credits:
10
Module Coordinator:
Dr Deborah Wallace
Trimester:
Autumn and Spring (separate)
Mode of Delivery:
On Campus
Internship Module:
No
How will I be graded?
Letter grades

Curricular information is subject to change.

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 and will complete GCP training.

About this Module

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 Component Scale Must Pass Component % of Final Grade In Module Component Repeat Offered
Assignment(Including Essay): Study 329 Week 12 Standard conversion grade scale 40% No

50

 No
Practical Skills Assessment: Protocol Presentation Week 15 Standard conversion grade scale 40% No

50

 No

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

• Peer review activities
• Self-assessment activities

How will my Feedback be Delivered?

Students receive feedback through class discussions

Name Role
Dr Marie Galligan Tutor
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