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What is an investigator statement?

The Statement of Investigator, Form FDA 1572, is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations for conducting a clinical investigation.

Who submits form FDA 1572?

In general, if an individual is directly involved in the performance of procedures required by the protocol, and the collection of data, that person should be listed on the Form FDA 1572.

What is the purpose of the FDA form 3674?

Requirements for Certification of Compliance with Certain Product Applications. FDA developed Form FDA 3674 which may be used to provide certification. The certification must accompany certain human drug, biological product and device applications and submissions.

Who completes form FDA 1572?

When new investigators are assigned to a clinical investigation under an investigational new drug application (IND), the sponsor completes and signs a Form 1572 before allowing the investigator to get involved in the clinical investigation.

Which party submits the completed signed form FDA 1572 to the FDA?

Principal Investigators on treatment protocols that involve an Investigational New Drug (IND) must complete Form FDA 1572, which the sponsor then submits to FDA.

What is the purpose of the 1572 form?

A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

Who is responsible for the conduct of the study ing to the FDA 1572?

The investigator is responsible for conducting studies in ance with the protocol (see 21 CFR 312.60, Form FDA-1572, 21 CFR 812.43 and 812.100).

Omb no 0910 0014 form-2025

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