
Your site is weeks past study initiation and all the candidates that you expected to be screening for the study have not materialized. Would trial-related advertising or recruitment materials enhance your sites' enrollment efforts?
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In clinical research, the purpose of an Institution Review Board (IRB) is to review and approve research studies involving human subjects. Its purpose first and foremost is to protect patients by ensuring the rights, safety, and well-being of potential research subjects. 21 CFR part 56 contains general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA.
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