Questions and Answers
Who is responsible for reporting the investigator's financial interests with the sponsor to the FDA?
the sponsor
What does the Investigator agree to in completing Form FDA 1572, Statement of Investigator?
conduct or supervise the investigation personally
What is Form FDA 1572, Statement of Investigator, legally binding between?
the Investigator and the FDA
To whom must the investigator report adverse events?
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When must the investigator update the IRB about the progress of a trial?
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What is one of the investigator's commitments to the sponsor?
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Study Notes
Investigator Obligations in FDA-Regulated Research
- The sponsor is responsible for reporting the investigator's financial interests to the FDA.
- Completing Form FDA 1572 signifies the investigator's commitment to personally conduct or supervise the investigation.
- Form FDA 1572 is a legally binding document, establishing obligations between the investigator and the FDA.
- Adverse events must be reported by the investigator to the sponsor for compliance and safety monitoring.
- The investigator must keep the Institutional Review Board (IRB) updated about the trial's progress both during the study and at its termination.
- Investigators are obligated to submit a new Form FDA 1572 to the sponsor whenever necessary, reflecting any changes in the trial's circumstances or their role.
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Description
Test your knowledge on the responsibilities and obligations of investigators in FDA-regulated research. This quiz covers key aspects such as financial disclosures and the completion of Form FDA 1572. Perfect for those involved in clinical trials and pharmaceutical research.
