Children's Cancer and Leukaemia Group
Clinical Trials
Introduction to Clinical Trials

The role of the Trial Coordinator

It is the trial coordinator in the Trials Unit who is responsible for a trial in terms of data collection and conduct of administrative matters relating to that trial. When a new trial is being set up the trial coordinator, through experience in the necessity for attention to detail, should be able to see whether all terms used in the protocol are precisely defined, if definitions are clear enough, if frequency of follow up is defined, etc. The trial coordinator should also design/review any new forms to ensure that they are clear, easy to complete, contain all the relevant information, and do not contain unnecessary information.

Once the trial is up and running the Trial Coordinator will be the focal point for all aspects of trial conduct (form return, resolution of queries, data checking, data entry, generation of reports, follow up etc).

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  1. Introduction
  2. What is a Clinical Trial?
  3. Clinical Trial procedure
  4. The role of the Chief Investigator
  5. The Protocol
  6. How is the size of a clinical trial determined?
  7. What is a multi-centre trial?
  8. Role of coordinating centre/Trials Unit
  9. What is randomisation?
  10. How is a patient randomised for a particular trial?
  11. What is a control in clinical trials?
  12. Forms and data management
  13. Statistics in clinical trials
  1. The role of the trial coordinator
  2. Follow up
  3. How is the trial data analysed/evaluated?
  4. What are pharmacokinetic studies?
  5. Ethical issues
  6. Conduct of Clinical Trials/Research
  7. What is a blind trial?
  8. Interpretation and publication of findings
  9. Survival Curves
  10. CCLG Protocols – development and approval process
  11. References
  12. Download PDF