CITI: Investigator Obligations in FDA-Regulated Research
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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
