MDCS42240 Medical Research Design, Regulations & Ethics

Academic Year 2022/2023

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


Online Learning




Approaches to Teaching and Learning:
Online Course 
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: GCP Assignment Throughout the Trimester n/a Graded No


Examination: MCQ 1 hour End of Trimester Exam No Graded No


Carry forward of passed components
Resit In Terminal Exam
Spring No
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?

Not yet recorded.

Name Role
Dr Sinead Holden Lecturer / Co-Lecturer
Dr Deborah Wallace Lecturer / Co-Lecturer