Clinical Trial Management

Course summary

  • Mon 18 Jun 2018 to Fri 22 Jun 2018
  • Rewley House, 1 Wellington Square, Oxford, Oxfordshire, OX1 2JA.
  • From £1795.00
  • 20 CATS points
  • Course code O17C210B9Y
  • cpdhealth@conted.ox.ac.uk
  • +44 (0) 1865 286941
  • Applications being accepted

Clinical Trial Management



Overview

Developing best practice for the management and delivery of clinical trials.

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 delivery. Students will learn about the practical steps involved in setting up and managing clinical trials. While there will be a focus on UK practice, 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).

The last date for receipt of complete applications is 5pm Friday 1st June 2018. Regrettably, late applications cannot be accepted.

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

  1. Appreciate the key position that randomised controlled trials play in translation research.
  2. Understand the different study designs employed by CTUs and the benefits of each.
  3. Be able to classify a clinical research study appropriately and have an understanding of the associated regulatory framework.
  4. Be able to develop a detailed trial protocol compliant with all applicable regulations.
  5. Understand the lifecycle of a clinical trial including development of detailed project plans, understanding the approvals process, the importance of a statistical analysis plan, data management plan and risk based trial monitoring, and knowing how to set and monitor milestones and take corrective action.
  6. Understanding the role of a Clinical Trials Unit.
  7. Have an awareness of the support available for research networks in the UK.

 

Core Reading

 

  • Fundamentals of clinical trials. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets. Springer; 4th ed. 2010
  • Clinical Trials: A practical guide to design, analysis and reporting. Wang D, Bakhai A. Remedica; 1st ed. 2006
  • SPIRIT 2013: New guidance for content of clinical trial protocols. Chan AW, TetzlaffJM, Altman DG, Dickersin K, Moher D. Lancet. 2013 Jan 12;381(9861) :91-2

 

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), 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).

Accommodation

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.

Fees

Short Course in Health Sciences: £2195.00
Students enrolled on MSc in Evidence-Based Health Care: £1795.00
Students enrolled on Postgraduate Cert in Health Research: £1795.00
Students enrolled on Postgraduate Dip in Health Research: £1795.00

Funding

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

Discounts

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.

Tutor

Dr Emma Ogburn

Module Coordinator

Emma Ogburn is Senior Clinical Trials Manager at the Nuffield Department of Primary Care Health Sciences.

Assessment methods

Assessment will be based on submission of a written assignment which should not exceed 4,000 words.

Academic Credit

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

Attendance Only

This includes:

  • attendance at five full days of teaching by world renowned experts in evidence-based health care at the University of Oxford.
  • access to a dedicated online virtual learning environment prior to and during the five taught days
  • access to pre-course reading materials

Applicants registering as "Attendance Only" are not eligible to undertake the academic assignment offered to students on award-bearing programmes of study and will not have access to the University library resources, other than those provided by the Department for Continuing Education. Applicants cannot receive CAT (Credit Accumulation and Transfer Scheme) points or equivalence. Credit cannot be attributed retrospectively. CAT accreditation is required if you wish for the module to count towards a further qualification in the future.

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

“Attendance Only" applicants who subsequently wish to register for academic credit and complete the assignment are required to submit additional information, which must be received 1 calendar month in advance of the module start date. Please contact us for more information.

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

Application

We strongly recommend that you download and save files before completing to ensure that all your changes are saved.

This course requires you to complete the application form and submit along with a copy of your CV. If you are applying to take this course for academic credit you will also need to complete section two of the reference form and forward it to your referee for completion. 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 before completing the application form, as any errors resulting from failure to do so may delay your application.

Selection criteria

Admissions 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
  • 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.