MDCS41900

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:

Approaches to Teaching and Learning:

Requirements, Exclusions and Recommendations

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

Module Requisites and Incompatibles

Assessment Strategy

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