- When a new protocol is added and the investigator must employ that protocol
- 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.