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FDA 1572 Statement of Investigator - ccrod cancer-2025

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The document is a Statement of Investigator (Form FDA 1572) required by the Food and Drug Administration (FDA) for clinical investigations involving investigational drugs. It outlines the necessary information that an investigator must provide, including their qualifications, details about the research facility, clinical laboratories, and the Institutional Review Board (IRB) overseeing the study. The form also includes commitments from the investigator to adhere to regulatory requirements and ethical standards during the investigation.

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Which of the following must be filed using a form FDA 1572?

The FDA Form 1572 must be filed when there is an addition of a new investigator to a clinical trial team. It does not require updating for annual reports or protocol amendments unless a new investigator is introduced. Thus, the answer is B: Addition of a new investigator.

What entities should be listed on a form 1572?

The Form FDA 1572/DAIDS IoR Form must list all IRBs/ECs/REs/Approving Entity(ies) that are responsible for the review and approval of a clinical trial at a CRS prior to the CRSs initiation of the protocol.

What is the statement of investigator form FDA 1572?

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 documentation must accompany the form 1572 submission?

The investigator is required to attach either a Curriculum Vitae (CV) or Other Statement of Qualifications showing the education, training and experience that qualifies the investigator as an expert in the clinical investigation of the drug/biologic for the use under investigation.

What are the responsibilities of Pi in 1572?

21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted ing to the signed investigator statement (the FDAs 1572 form), the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigators care; and for the

Who submits form 1572 to FDA?

The site investigator is responsible for updating his/her 1572 form and providing it to the sponsor in a timely manner so the information can be sent to the FDA.

What reports must be filed using a form FDA 1572?

A form that must be filed by an investigator running a clinical trial to study a new drug or agent.

FDA 1572 Statement of Investigator - ccrod cancer-2025

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Which of the following must be filed using a form FDA 1572?

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FDA 1572 Statement of Investigator - ccrod cancer-2025

Here's how it works

How to edit FDA 1572 Statement of Investigator - ccrod cancer in PDF format online

See more FDA 1572 Statement of Investigator - ccrod cancer versions

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Got questions?

Which of the following must be filed using a form FDA 1572?

What entities should be listed on a form 1572?

What is the statement of investigator form FDA 1572?

What documentation must accompany the form 1572 submission?

What are the responsibilities of Pi in 1572?

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