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 subinvestigators, 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. The sponsor can accumulate certain changes and submit
this information to the IND in, for example, an information amendment or a protocol
amendment.