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