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What type of protocol/ICF amendments qualifies for expedited or full-board review?

April 26, 2017amendments Expedited full-board ICF Protocol qualifies review type

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What type of protocol/ICF amendments qualifies for expedited or full-board review?

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Minor amendment and administrative amendment to the Protocol or ICF is subjected to expedited review. Major amendment to the Protocol or Informed Consent Form that increase the overall risk benefit ratio is subjected to a full-board review. Please submit the PIEC Protocol Amendment Note together with a tracked changes and clean copy of the document.