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Stanford University Research Compliance OfficeSpecial Considerations for the Oversight of Research Protocols in FDA regulated Drug or Device StudiesGUI26mINVESTIGATIONAL DRUG STUDIES 1. Before beginning
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Special considerations for form is a document used to report any unique circumstances or exceptions that may apply to a particular situation.
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The purpose of special considerations form is to provide a clear and transparent record of any special circumstances or exceptions that may impact a particular situation.
The information that must be reported on the special considerations form includes details about the special circumstances or exceptions, as well as any relevant supporting documentation.
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