Terms You Should Know: Protocol
| Assent | IRB | Randomization |
| Blinding or Masking | Placebo | |
| Informed Consent | Protocol |
Protocol
"A detailed plan that says who can be in a study, for how long, and what will happen. It's like the rules."
The Clinical Study Protocol is the document that describes a study...why the study is being done, how the study will be conducted and how results will be analyzed. If the study is taking place at many different locations, study teams at each site will use the protocol to perform the study in exactly the same way.
The protocol will describe:- Why the study is being done.
- What types of children can be in the study.
- When the visits, tests and procedures will take place.
- The types of medicines and dosages to be used.
- How long the study will last.
- How children will be kept safe.
- Possible benefits and risks.
- How privacy will be protected.
- How side effects will be monitored and reported.
- Who will monitor the safety of the study participants and how often.
- How the results will be analyzed.
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