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Fda 1572-2025

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The document is the Statement of Investigator (Form FDA 1572) required by the Food and Drug Administration (FDA) for clinical investigators participating in drug investigations. It outlines the necessary information that must be provided by the investigator, including their qualifications, details about the research facilities, and commitments to conduct the study in compliance with regulatory requirements. The form must be completed and signed before an investigator can participate in a clinical trial.

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Who is the FDA 1572 statement of investigator legally binding between?

In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: Conduct or supervise the investigation personally. Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the: FDA.

What is the FDA 1572 for?

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.

What is the most important part of 1572?

Form FDA 1572 serves two main purposes: The first is to provide the sponsor with the investigators qualifications and information about the clinical site. The second purpose is to inform and clarify the obligations of the investigator and to acquire investigators commitment to follow pertinent FDA regulations.

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.

Who completes Form FDA 1572?

No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572 (21 CFR 312.53(c)) Page 4 What is the FDA Form 1572?

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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.

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).

Fda 1572-2025

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