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U.S. Department of Health and Human Services

For Industry

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Study Participation Standard

The Study Participation standard captures information about experimental units, investigators, and other relevant entities that are involved in the conduct of an individual study. A study in this context is any investigation performed to support the safety, effectiveness, or quality of a medical product. As such, the experimental unit of a study can be human, other non-human living subjects, parts of non-human living subjects, groups of nonhuman living subjects, or the medical product itself. Study Participation standard may be used at the start of the study, as part of a subsequent update on the study and as part of the final study report.