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

The role of the Chief Investigator

For multi-centre trials there will be a designated Chief Investigator or lead Clinician. Prior to commencement of a trial, the Chief Investigator is responsible for preparation of the protocol. During the conduct of the study he/she is in charge of medical monitoring (particularly toxicity/safety) and, finally, on completion of the study he is responsible for liaison with statistican over analysis, and finally for reporting the results.

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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