(5) Confirming or establishing the date for the next continuing review.
If the receiving IRB performs a review at the time of clinical investigation transfer (whether an
initial or a continuing review), it may choose to maintain the anniversary date of approval
established by the original IRB or decide to establish a new anniversary date. If the receiving
IRB decides to establish a new anniversary date, the new date must be within one year of the
receiving IRB’s review.
If the receiving IRB does not conduct a review of the clinical investigation at the time of transfer,
the date of clinical investigation approval by the original IRB is presumed to remain in effect for
the full approval period established at the time of the most recent review by the original IRB.
For example, if the original IRB initially approved the clinical investigation for one year
effective July 1, 2011, and the clinical investigation is transferred to a new IRB effective October
1, 2011, the expiration date of IRB approval would continue to be July 1, 2012, unless or until
the receiving IRB establishes a new expiration date. Note that review in accordance with a
newly established expiration date would nonetheless need to be conducted prior to the original
July 1, 2012 expiration date.
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