Clinical trials need instruction sheets because they can be anything from extremely complicated to impossibly complicated.
Protocols are the instruction sheets. The protocol, the informed consent form and the statistical analysis plan are prepared before a clinical trial can take place.
Following are 3 documents. The first is a section on the clinical study report that describes protocol violations during a clinical trial.By the time you have read these documents you should understand:
1. Why you need a clinical trial protocol
2. What are inclusion and exclusion criteria
3. What is a protocol violation
4. How to prepare a protocol.
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