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Practical Randomised Controlled Trials - HEA00112M

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

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.

Assessment

Task Length % of module mark
Essay/coursework
Essay 2500 Words		 N/A 100

Special assessment rules

None

Reassessment

Task Length % of module mark
Essay/coursework
Essay 2500 Words		 N/A 100

Module feedback

Written feedback will be provided on the standard proforma within the timescale specified in the programme handbook.

Indicative reading


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.