Clinical trials – a guide for CAB members (page 13)

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This slide shows what a research protocol is all about. A protocol is a very detailed written plan that describes all of the details about the clinical study:

  • Why the research needs to be done
  • The objectives of the study (what will be learned)
  • The medicines to be studied, and what is known about them
  • Whom the researchers are, who is in charge of the study, whom to contact with questions, etc
  • Who will participate in the study
  • Where the study will be done
  • Exactly how the study will be done (which tests will be done to monitor safety and effectiveness, what doses of medicine will be provided, etc)
  • The schedule for doctor or nurse visits, tests, and procedures (like taking blood), etc
  • Describe the potential safety issues and how they will be monitored
  • How adverse events (bad effects) will be managed
  • How the data collected will be analysed (studied) in order to best understand the results
Published: August 31, 2008
Last edited: January 25, 2011