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Randomised Controlled Trials - HEA00034M

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  • Department: Health Sciences
  • Module co-ordinator: Prof. David Torgerson
  • Credit value: 10 credits
  • Credit level: M
  • Academic year of delivery: 2021-22
    • See module specification for other years: 2022-23

Module will run

Occurrence Teaching period
A Autumn Term 2021-22

Module aims

To understand, critically review and be able to design a randomised controlled trial.

Module learning outcomes

At the end of the module, students will:

  1. Be able to write a funding proposal for a randomised trial.
  2. Be able to critically review published randomised trials.

Module content

The module will include covering the following:

  • Weaknesses of observational Studies, Regression discontinuity; Random allocation Pragmatic trials. Sources of bias in trials
  • Sample size, outcomes
  • Ethics Research Governance, writing a trial protocol, statistical aspects of trial design
  • Cluster design, factorial trials
  • Zelen’s method, Preference, Placebo trial designs, n = 1, cross-over, balanced design
  • Unequal allocation, trial quality, Increasing response rates to follow-up
  • Data management; pilot trials, cohort trial, Trial Recruitment
  • Trial cost, Economic evaluation alongside trials, Stepped wedge, publishing trials


Task Length % of module mark
Trial Protocol - 3000 words
N/A 100

Special assessment rules



Task Length % of module mark
Trial Protocol - 3000 words
N/A 100

Module feedback

Written feedback for summative assessment is provided on the standard proforma, within the timescale specified in the programme handbook.

Indicative reading

  • Torgerson, D. and Toergerson, C. (2008). Designing Randomised Trials in Health, Education and the Social Sciences. Palgrave Macmillan.

The information on this page is indicative of the module that is currently on offer. The University is constantly exploring ways to enhance and improve its degree programmes and therefore reserves the right to make variations to the content and method of delivery of modules, and to discontinue modules, if such action is reasonably considered to be necessary by the University. Where appropriate, the University will notify and consult with affected students in advance about any changes that are required in line with the University's policy on the Approval of Modifications to Existing Taught Programmes of Study.