MDCS41900 Clinical Protocol Development

Academic Year 2021/2022

This module forms part of the MSc in Clinical & Translational Research. The goal of this module is to provide students with an in-depth understanding of clinical trial protocols including their structure and how a scientifically appropriate protocol is developed.
Students will build on previous content as they design their own clinical research protocol. Students will
1) Formulate a research question
2) Prepare a study summary
3) Define the population for analysis including the sample size required
4) Write a protocol using the HPRA protocol template
Students will receive feedback throughout the protocol development process

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Curricular information is subject to change

Learning Outcomes:

On completion of this module, students will be able to design, develop and deliver a clinical trial protocol that is ethically, legally and regulatorily sound and statistically valid.
Specifically students will:
Propose a research question applicable to a clinical, occupational or scientific setting
Design a methodologically sound study to address their research question
Develop a clinical research protocol within a specified framework
Choose the study design most appropriate to the research question, including definition of endpoints and determination of sample size requirements
Understand the most appropriate control and intervention groups
Write up the clinical research protocol

Indicative Module Content:

In this module, students will be guided through the stages of protocol development, from research question to initial PICO and from study summary to completed protocol

Student Effort Hours: 
Student Effort Type Hours
Lectures

24
Tutorial

8
Seminar (or Webinar)

12
Specified Learning Activities

60
Autonomous Student Learning

100
Total

204
Approaches to Teaching and Learning:
Lectures
Active learning
Tasks
Presentations
Group work
Peer review and feedback 
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 Open Book Exam Component Scale Must Pass Component % of Final Grade
Assignment: Research Question (PICO) Throughout the Trimester n/a Graded No

15
Assignment: Study Summary Throughout the Trimester n/a Graded No

30
Assignment: Protocol Coursework (End of Trimester) n/a Graded No

55

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?

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

Name Role
Professor Patrick Murray Tutor
Dr Deborah Wallace Tutor