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Data - Rare Diseases
Data from patients with rare diseases, can include clinical treatment, diagnosis, among others.
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Rare Diseases
Recruitment of volunteers or study participants who have a rare disease, or specifically in the "U.S.when a chronic and enervating condition afflicts fewer than 200,000 people combined, and in the EU, when it affects fewer than approximately 250,000 people."
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Orphan Conditions
FDA requires that an Investigational Review Board (IRB) must review all the documents related to the inclusion of participants within clinical trials. IRB is expected to review all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. Specific for orphan conditions, this is the recruitment of patients with a rare disease that affects a small population of people.