Question

When must a 1572 be updated or a new 1572 completed and signed by PI?

A) Every two years
B) Only if there are no adverse events
C) Within 30 days of any change
D) After the study has concluded

Answer 1

A 1572 form must be updated or a new one completed and signed by the PI within 30 days of any changes that could affect the investigator's ability to meet their obligations or affect the conduct of the study.

Step-by-step explanation:

A 1572 form is used in clinical trials to document the agreement between the Principal Investigator (PI) and the sponsor. A 1572 form must be updated or a new one completed and signed by the PI within 30 days of any changes that could affect the investigator's ability to meet their obligations or affect the conduct of the study.

According to the FDA regulations, the 1572 form must be updated or a new one completed and signed by the PI within 30 days of any changes that could affect the investigator's ability to meet their obligations or that affect the conduct of the study.