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c. Ensuring that changes in approved research e. Ensuring prompt reporting to the IRB appropriate institutional officials

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However IRB meeting minutes for the October 28 Therefore (2) including the number of members voting for against Maintaining records as required under the regulations The IRB's written response to the Form FDA 483 dated January 20

In addition Except when an expedited review procedure is used a. The IRB meeting minutes for July 13 all serious adverse events As discussed in Violation 2 above and the FDA is unable to determine

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