Practical Randomised Controlled Trials - HEA00112M
- Department: Health Sciences
- Credit value: 10 credits
- Credit level: M
- Academic year of delivery: 2022-23
Module will run
| Occurrence | Teaching period |
|---|---|
| C | Summer Term 2022-23 |
Module aims
The aim of this module is to understand and navigate the practical issues involved in designing and conducting research projects using randomised controlled trial methodology, focusing on evaluation of healthcare interventions.
Module learning outcomes
To understand the relationships between sponsor, funder, research ethics, and governance.
To be able to design trial documents including patient facing information and data collection tools.
To be able to plan and achieve successful participant recruitment and retention within a randomised controlled trial.
To have developed skills to deliver a randomised controlled trial.
Structured practical sessions are set up to help you to understand and navigate these themes.
Module content
Sessions will include:
Good Clinical Practice (GCP) Training: Training relating to the international ethical, scientific and practical standard to which all clinical research is conducted.
Writing the protocol: Including key content, statistical considerations and randomisation.
Recruitment and retention of Participants: Including methods for study types, Studies within a Trial.
Designing Patient Facing Documentation: Including document types, design considerations, use of patient and public representatives.
Data Collection and Processing: Including types of data collection tools, design considerations, licencing, storage.
Trial Procedures: Including key concepts, procedure types, design considerations.
Applying for Approvals: Including types of approval and their differences, elements to consider when applying.
Site Set Up: Including site selection, training and set up processes.
Indicative assessment
| Task | % of module mark |
|---|---|
| Essay/coursework | 100 |
Special assessment rules
None
Indicative reassessment
| Task | % of module mark |
|---|---|
| Essay/coursework | 100 |
Module feedback
Written feedback will be provided on the standard proforma within the timescale specified in the programme handbook.
Indicative reading
- Torgerson, D. and Torgerson, C. (2008). Designing Randomised Trials in Health, Education and the Social Sciences. Basingstoke, UK: Palgrave Macmillan.
- UK Trial Managers Network (McDonald A, Farrell B, Booth G, Buckland S, Foster K, Harper L et al, editors). The guide to efficient trial management. Available at: https://cdn.ymaws.com/www.tmn.ac.uk/resource/resmgr/TMN_Guide/UKTMN_Guide_for_Web_V5_May_2.pdf
- ICH Good Clinical Practice. Available at: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendum-good-clinical-practice.html
- Health Research Authority. Available at: https://www.hra.nhs.uk/
- National Institute for Health Research (NIHR) Clinical trial toolkit. Available at: http://www.ct-toolkit.ac.uk/