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


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