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Clinical Trial Management Course
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Clinical Trial Management Course

How to successfully design, set-up, manage, close and publish good quality clinical trials

 Export to Your Calendar 03/06/2019 to 07/06/2019
When: Monday, June 3, 2019
Where: Rewley House
1 Wellington Square
Oxford, Oxfordshire  OX1 2JA
United Kingdom
Contact: Dr Emma Ogburn
01865 286941

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The last date for receipt of complete applications is 5pm Friday 17th May 2019. Regrettably, late applications cannot be accepted.

This module will focus on providing an understanding of the lifecycle of a clinical trial from design to publication and the key steps involved in their successful delivery. Students will be taught by experienced trialists with extensive knowledge of making trials work in every setting, teaching best practice for the practical steps involved in setting up and the daily management of clinical trials. While there will be a focus on UK practice in primary and secondary care, the knowledge gained will be applicable across a number of research settings and countries, particularly those who are signatories to the ICH-GCP tripartite agreement (EU, Japan and United States, 1996).


By the end of the course the student will be able to:

  • Appreciate the key position that randomised controlled trials play in translational research.
  • Be able to plan all aspects of the trial, including design and statistical analysis plans, data management plans and risk based trial monitoring; set up and understanding the approvals process; daily trial management including how to set and monitor milestones and safety data and take corrective action; closing and publication.
  • Understand the different study designs employed by CTUs and the benefits of each.
  • Be able to classify a clinical research study appropriately and have an understanding of the associated regulatory framework.
  • Be able to develop all essential trial documents compliant with all applicable regulations.
  • Understand the role of a Clinical Trials Unit.
  • Have an awareness of the support available for research networks in the UK.

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), there are then four Post-Oxford activities (delivered through the VLE) which are designed to help you write your assignment. You then have a week 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).

 

Full details and information on how to  apply can be found on the course webpage - http://www.conted.ox.ac.uk/ctm