CITI: Investigator Obligations in FDA-Regulated Research

Form FDA 1572, Statement of Investigator, is legally binding between the investigator and the:

FDA

In completing Form FDA 1572, Statement of Investigator, the investigator agrees to

Conduct or supervise the investigation personally

When must the investigator update the IRB about the progress of a trial?

During the conduct of the study and at termination

The investigator must report adverse events to the:

Sponsor

Which of the following is an investigator's commitment to the sponsor?

Submit a new Form FDA 1572 to the sponsor as needed