Randomised Controlled Trials


Designing and improving your trial with the experts

This module will take students through the process of undertaking a randomised trial. It will focus on the practicalities of organising and running trials, and build on theory from the introductory modules. The module will use a problem-based learning approach in which each participant brings a specific topic for a trial to discuss, justify and revise during the module. Participants will consider the practicalities from the perspective of potential principal investigators, including the processes for resourcing the trial, recruiting and randomising participants, maintaining the trial's momentum, and analysing and reporting it.

The last date for receipt of complete applications is 5pm Friday 11th March 2022. Regrettably, late applications cannot be accepted.

The overall aims of this module are to enable students to;

  • specify a clear question for a randomised trial
  • specify the inclusion and exclusion criteria for the participants in a trial
  • prepare and submit an entry for the trial in an appropriate register
  • identify appropriate strategies for recruiting patients, including information leaflets and obtaining consent
  • prepare a clear timeline for the study, relating to both the passage of an individual patient through the trial and also to the study as a whole
  • determine what resources, both financial and personal, are needed for a trial
  • determine and implement an appropriate method of randomisation for a trial
  • prepare a statistical analysis plan for a randomised trial
  • plan and implement strategies to maintain or increase recruitment to a randomised trial
  • prepare a high quality report of the findings of a randomised trial
  • use this knowledge to assess the quality and relevance of randomised trials done by others


Comments from previous participants:

"Interactive sessions with lots of helpful and practical information for understanding and conducting a RCT."

Programme details

This module is run over an eight week cycle where the first week is spent working on introductory activities using a Virtual Learning Environment, the second week is spent in Oxford* for the face to face teaching week (this takes place on the dates advertised), you then have five weeks of personal study and you will be required to submit your assignment electronically the following week (usually on a Tuesday at 14:00 UK Local Time).

*As a result of travel restrictions and the ongoing situation regarding Covid-19, this module is now being delivered entirely online.


Description Costs
Short Course in Health Sciences £2570.00
Students enrolled on MSc in Evidence-Based Health Care £2080.00
Students enrolled on Postgraduate Cert in Health Research £2080.00
Students enrolled on Postgraduate Dip in Health Research £2080.00


Details of funding opportunities, including grants, bursaries, loans, scholarships and benefit information are available on our financial assistance page.


If you are an employee of the University of Oxford and have a valid University staff card you may be eligible to receive a 10% discount on the full stand-alone fee. To take advantage of this offer please submit a scan/photocopy of your staff card along with your application. Your card should be valid for a further six months after attending the course.


Professor Mike Clarke

Module Coordinator

Mike Clarke is Chair of Research Methodology and Director of the Northern Ireland Methodology Hub based at Queen’s University Belfast and Director of the Northern Ireland Clinical Trials Unit. After achieving a first class BA in Chemistry at the University of Oxford in 1984, Mike did a DPhil on the history of suicide, with special emphasis on the use of poisons. He started work in health research in 1989 at the Clinical Trial Service Unit in Oxford, where he became responsible for collaborative overviews of cancer treatments. In these systematic reviews, individual participant data are collected and analysed for all patients entered into relevant trials. The largest of the projects concerns the treatment of women with breast cancer and has produced reliable and robust evidence which influences the care of women with breast cancer worldwide. In 1999, Mike became Associate Director (Research) at the UK Cochrane Centre and was its Director from 2002 to 2011, before moving to Queen’s University Belfast.

Mike has considerable experience in the conduct of large multicentre randomized trials and systematic reviews. He has been actively involved with trials in pre-eclampsia, subarachnoid haemorrhage, breast cancer, paediatric intensive care and poisoning – each of which are among the largest ever randomized trials in these conditions. He has also provided detailed advice for hundreds of other trials, processed and interpreted the individual participant data (IPD) from more than a thousand trials included in systematic reviews, and assessed reports for tens of thousands more as part of initiatives to improve access to research information.

Mike has been involved with the MSc in Evidence Based Health Care since it began, and developed the Randomized Trials and Systematic Reviews elective modules, which he continues to teach. He helped establish the SWAT and SWAR (Study Within A Trial/Review) programme to encourage the embedding of methodology research into prospective studies and reviews. He is also actively involved in promoting research-based knowledge in disasters and humanitarian emergencies, through Evidence Aid. Mike received the title Professor of Clinical Epidemiology from the University of Oxford in 2004 and is Visiting Professor at the Evidence Based Medicine and Clinical Epidemiology Centre of the West China School of Medicine in Chengdu, Extraordinary Professor in Clinical Epidemiology at Stellenbosch University in South Africa and Honorary Professor in Biostatistics at the University of Liverpool. He is an author on more than 400 papers and book chapters.

Assessment methods

Assessment will be based on submission of two written assignments which should each not exceed 1,500 words.

Academic Credit

Applicants may take this course for academic credit. The University of Oxford Department for Continuing Education offers Credit Accumulation and Transfer Scheme (CATS) points for this course. Participants attending at least 80% of the taught course and successfully completing assessed assignments are eligible to earn credit equivalent to 20 CATS points which may be counted towards a postgraduate qualification.

Applicants can choose not to take the course for academic credit and will therefore not be eligible to undertake the academic assignment offered to students taking the course for credit. Applicants cannot receive CATS (Credit Accumulation and Transfer Scheme) points or equivalence. Credit cannot be attributed retrospectively. CATS accreditation is required if you wish for the course to count towards a further qualification in the future.

A Certificate of Completion is issued at the end of the course.

Applicants registered to attend ‘not for credit’ who subsequently wish to register for academic credit and complete the assignment are required to submit additional information, which must be received one calendar month in advance of the course start date. Please contact us for more details.

Please contact cpdhealth@conted.ox.ac.uk if you have any questions.


This course requires you to complete the application form and to attach a copy of your CV, along with the additional information form below. If you are applying to take this course for academic credit you will also be required to provide a reference. Please note that if you are not applying to take the course for academic credit then you do not need to submit a reference.

Please ensure you read the guidance notes which appear when you click on the symbols as you progress through the application form, as any errors resulting from failure to do so may delay your application.

Selection criteria

To apply for the course you should:

  • Be a graduate or have successfully completed a professional training course
  • Have professional work experience in the health service or a health-related field
  • Identify a work based problem for which you will be seeking evidence
  • Be able to combine intensive classroom learning with the application of the principles and practices of evidence-based health care within the work place
  • Have a good working knowledge of email, internet, word processing and Windows applications (for communications with course members, course team and administration)
  • Show evidence of the ability to commit time to study and an employer's commitment to make time available to study, complete course work and attend course and university events and modules.
  • Be able to demonstrate English Language proficiency at the University’s higher level


Accommodation is available at the Rewley House Residential Centre, within the Department for Continuing Education, in central Oxford. The comfortable, en-suite, study-bedrooms have been rated as 4-Star Campus accommodation under the Quality In Tourism scheme, and come with tea- and coffee-making facilities, free Wi-Fi access and Freeview TV. Guests can take advantage of the excellent dining facilities and common room bar, where they may relax and network with others on the programme.

IT requirements

Please ensure that you have access to a computer that meets the specifications detailed on our technical support page.