deviation request form
CPGM 7356.021 Drug Quality Reporting System (DQRS)
It was designed to simplify reporting to FDA by means of consolidating several FDA reporting programs involving drugs, biologics, devices, and medical foods
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Deviations
Oct 30, 2024 OFR allows agencies to request deviations from ACFR regulatory requirements and OFR style and format requirements.
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Protocol Deviation Form
This form is designed to complement a Protocol Deviation Log which can be used for overall study tracking while this is for individual event documentation. This
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