The study protocol is the blueprint that all researchers will follow.
A study protocol is a document that describes, in detail, the plan for conducting the clinical study. The study protocol explains the purpose and function of the study as well as how to carry it out. Some specific things included in the protocol are the reason for the study, the number of participants, eligibility and exclusion criteria, details of the intervention or therapy the participants will receive (such as frequency and dosages), what data will be gathered, what demographic information about the participants will be gathered, steps for clinical caregivers to carry out, and the study endpoints. A single standard protocol must be used without deviation to ensure that the resulting data will be significant and reliable.
The NICHD expects that each study protocol will include a monitoring plan that defines:
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