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What is the most important aspect of 1572?

The first is to provide the sponsor with the investigators qualifications and information about the clinical site. In summary, the first purpose is to inform the sponsor that the investigator is qualified, and the clinical site is an appropriate location for clinical investigation.

Who signs Form 1571?

For a sponsor-investigator IND, the sponsor-investigator should be named and must sign the form. For an IND sponsored by a pharmaceutical firm or research organization, the name of the sponsors authorizing representative should be entered and that individual must sign the form.

What is a Form 1572 per the FDA?

The Statement of Investigator (Form FDA 1572) is a form that is required to be filled for clinical trials involving investigational drugs or biologics.

Who fills out 1572?

The Statement of Investigator, Form FDA 1572, is a document that must be completed and signed by the lead investigator for each clinical investigation conducted under an Investigational New Drug Application (IND).

What do you need for Form 1572?

Completing Form FDA 1572 The investigators full legal name (e.g., name on the investigators birth certificate or marriage certificate) must be used. The work address where the investigator can be docHubed by mail or in person should be entered. An administrative room number within a building must be included.

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Is FDA 1572 form an essential document?

Explanation: Accuracy on FDA Form 1572 is essential since it serves as an agreement between investigational sites and the Food Drug Administration (FDA).

What is the guidance on the 1572 waiver?

The revised draft guidance clarifies that if a non-U.S. investigator cannot or will not sign the investigator statement (e.g., because regional, national, or local laws or regulations prohibit its signing), the revised guidance clarifies that a sponsor may submit a request for a waiver of the 1572 signature requirement

Who fills out 1572?

The Statement of Investigator, Form FDA 1572, is a document that must be completed and signed by the lead investigator for each clinical investigation conducted under an Investigational New Drug Application (IND).

What is the purpose of Form 1572?

provide certain information to the Sponsor about the Principal Investigators qualifications and the clinical site. appropriate location at which to conduct the clinical investigation. regulations related to the conduct of a clinical investigation of an investigational drug or biologic.

What is Form 1571 and 1572?

Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.

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