Investigator Obligations in FDA-Regulated Research Quiz
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When must the investigator update the IRB about the progress of a trial?
During the conduct of the study and at termination
Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the:
FDA.
Which of the following is an investigator's commitment to the sponsor?
Submit a new Form FDA 1572 to sponsor as needed
The investigator must report adverse events to the:
Sponsor.
In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to:
Conduct or supervise the investigation personally.
Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor:
The sponsor