About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

There are two instances where the investigator must complete and sign a new 1572:

  1. When a new protocol is added and the investigator must employ that protocol
  2. When a new investigator is added to the investigation(21 CFR 312.53(c))

If there are any changes to the information on the signed and dated 1572, the investigator must document the changes in the study records and update the sponsor. The sponsor must update the IND accordingly. However, the 1572 does not need to be edited and a new one is not required. The sponsor can collect certain information and implement them to the IND. Examples of such information are an amendment or protocol amendment.


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