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MDCS41900

Academic Year 2024/2025

Clinical Protocol Development (MDCS41900)

Subject:
Medicine Clinical Science
College:
Health & Agricultural Sciences
School:
Medicine
Level:
4 (Masters)
Credits:
10
Module Coordinator:
Dr Marie Galligan
Trimester:
Spring
Mode of Delivery:
Blended
Internship Module:
No
How will I be graded?
Letter grades

Curricular information is subject to change.

This module forms part of the MSc in Clinical & Translational Research. The goal of this module is to build upon previous study of clinical research methodologies and equip students with a broader and more in-depth understanding of research study designs and their implementation and analysis, including:
• Observational studies
• Diagnostic studies - observational and test-treatment designs
• Randomised controlled trials – designs to include parallel, crossover, adaptive, platform etc..
• Study within a trial (SWAT)
The strengths and limitations of these designs are covered. The module will equip students with the ability to determine optimal, efficient and feasible strategies for evaluation of a research question.

About this Module

Learning Outcomes:

• Critique and refine a research question
• Demonstrate an in-depth understanding of a wide range of clinical research study designs including a variety of observational, diagnostic and clinical trial designs
• Determine innovative research approaches suitable for evaluation of different types of research questions
• Have knowledge of the advantages, complexities and limitations of biomarker-driven designs such as basket and platform trials.
• Demonstrate awareness of the statistical methods involved in evaluating study data and be able to apply this understanding to specific examples.

Indicative Module Content:

This module includes content in the following key areas

1) Advanced trial designs
2) Observational study methodologies
3) Diagnostic study design and analysis

Student Effort Hours:
Student Effort Type Hours
Specified Learning Activities

90
Autonomous Student Learning

114
Lectures

24
Tutorial

10
Online Learning

12
Total

250

Approaches to Teaching and Learning:
Lectures
Active learning activities
Weekly tasks
Group work
Online content
Additional reading

Requirements, Exclusions and Recommendations
Learning Requirements:

Prior to undertaking this module, students should have a detailed knowledge of biostatistics and data management


Module Requisites and Incompatibles
Pre-requisite:
MDCS41950 - Biostatistics &Data Management


 

Assessment Strategy
Description Timing Component Scale Must Pass Component % of Final Grade In Module Component Repeat Offered
Assignment(Including Essay): This module will involve continuous assessment. An assignment will be administered after each of 8 in-person sessions based on content covered. Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 Standard conversion grade scale 40% No
100
 No

Carry forward of passed components
Yes
 

Resit In Terminal Exam
Summer No
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
• Feedback individually to students, post-assessment
• Group/class feedback, post-assessment
• Peer review activities
• Self-assessment activities

How will my Feedback be Delivered?

Feedback is provided on a continuous basis to students, throughout this module. Students also engage in peer review and feedback

Name Role
Professor Peter Doran Lecturer / Co-Lecturer
Dr Linda O'Neill Lecturer / Co-Lecturer
Dr Deborah Wallace Lecturer / Co-Lecturer
Professor Patrick Murray Tutor
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