PI CV address and 1572 Section 3 address not matching

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    • #3568
      Daniella Chambers

      What is the best practice when the PI CV address doesn’t match the address listed in the Section 3 of the 1572 form?

    • #3624
      Jenn Leaning

      Hi Daniella,

      I think it would depend on which address is correct? Or does the address on the CV at least match the address under Section 1?

      The FDA guidelines state that there are two instances when it is necessary for an investigator to complete and sign a new 1572: when an investigator is participating in a new protocol that has been added to the IND and when a new investigator is added to the study (21 CFR 312.53(c)).

      If there are other changes to information contained on a signed and dated 1572 (e.g., an IRB address change, the addition of new sub-Is, the addition of a clinical research lab), the investigator should document the changes in the clinical study records and inform the sponsor of these changes, so that the sponsor can appropriately update the IND. The 1572 itself does not need to be revised and a new 1572 need not be completed and signed by the investigator.

      … With that said, if the address on the CV is incorrect/not up to date, then I feel it would be reasonable to request the PI to update his/her CV to reflect the most current/accurate information for your study files.

      Also just my two cents…If I’m not mistaken, my understanding is that the address in Section 3 doesn’t necessarily have to be the same as the PI’s CV, but the address under Section 1 should match the information on the PI’s CV 🙂

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