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

 Export to Your Calendar 26/06/2017 to 30/06/2017
When: Mon 26 Jun 2017 to Fri 30 Jun 2017
Where: Map this event »
Rewley House
1 Wellington Square
Oxford OX1 2JA
United Kingdom
Contact: 01865 286941

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Register HERE (link to external website)

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.

 

Full details and information on how to apply can be found on the course webpage.