MDCS42240 Medical Research Design, Regulations & Ethics

Academic Year 2024/2025

This module forms part of the MSc Artificial Intelligence for Medicine & Medical Research (X903) and the MSc in Data Analytics for Precision Medicine (X889) . The goal of this module is to provide an overview of ethics and regulation in research, clinical trial design, medical biostatistics and data management that will allow completion of a programme of clinical research.
Specifically, this Module will:
-Explain the importance of Good Clinical Practice, Ethics and Regulation in clinical research
-Explain study designs used in clinical research
-Discuss practical methods for analysis and management of data obtained during clinical & translational research studies

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Curricular information is subject to change

Learning Outcomes:

On completing this module, students will be expected to be able to participate effectively in any real life professional learning experience by integrating into a research team and apply their academic experience and their theoretical knowledge in a professional research setting.
Specifically students will:
Understand Good Clinical Practice, Ethics and Regulation in clinical research
Understand clinical trial principles including study design
Understand the core considerations of experimental / study design and data management
Understand common statistical approaches applied to data generated from clinical trials

Indicative Module Content:

Good clinical Practice
Medical Research Regulations
Research ethics
Study Designs

Student Effort Hours: 
Student Effort Type Hours
Autonomous Student Learning

40

Lectures

40

Online Learning

20

Total

100

Approaches to Teaching and Learning:
Lectures
tutorials
Online Course 
Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Incompatibles:
MDCS41630 - Clin & Translational Research, MDCS41640 - Clinical Trials


 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Exam (Online): MCQ n/a Standard conversion grade scale 40% No

100


Carry forward of passed components
Yes
 
Resit In Terminal Exam
Spring No
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Online automated feedback

How will my Feedback be Delivered?

Feedback will be provided through learning activities at tutorial sessions

Name Role
Dr Marie Galligan Lecturer / Co-Lecturer
Ms Ash Venugopalan Lecturer / Co-Lecturer
Dr Deborah Wallace Lecturer / Co-Lecturer