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Fda 1572-2025

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The document is a Form FDA 1572, known as the Statement of Investigator, 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 facility, institutional review board (IRB) information, and commitments to conduct the study according to regulatory standards. The form must be completed and signed before an investigator can participate in a clinical trial.

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Click ‘Get Form’ to open the FDA 1572 in the editor.
Begin by filling in your name and address in Section 1. Ensure that all details are accurate, as this identifies you as the clinical investigator.
In Section 2, provide your education, training, and experience. You can upload your curriculum vitae or another statement of qualifications directly through our platform.
For Sections 3 and 4, enter the names and addresses of the medical school or research facility and any clinical laboratory facilities involved in the study.
Complete Section 5 by providing the name and address of the Institutional Review Board (IRB) responsible for approving your study.
In Section 6, list any sub-investigators. If none, simply enter 'None'.
Fill out Section 8 with a detailed outline of your clinical protocol information based on the phase of investigation.
Finally, review all sections for accuracy, sign and date at the bottom before forwarding it to your sponsor as instructed.

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Versions	Form popularity	Fillable & printable
2019	4.9 Satisfied (21 Votes)
2016	4.4 Satisfied (225 Votes)
2013	4.3 Satisfied (81 Votes)
2013	4.7 Satisfied (39 Votes)
2006	4 Satisfied (54 Votes)

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What is the purpose of the FDA 1572?

When an investigator is participating in a new protocol that has been added to the IND. When a new investigator is added to the study (21 CFR 312.53(c)). It must be completed and signed before an investigator can participate in a clinical investigation. in section #9 of the Form FDA 1572.

Is 1572 required for IND submission?

Failure to comply with the requirements of Form FDA 1572 can lead to docHub consequences for researchers and sponsors. Regulatory penalties for non-compliance can include fines, suspension of the study, or even disqualification of the investigator from future research. The Importance of Form 1572 in Clinical Research Compliance bioaccessla.com blog the-importance-of- bioaccessla.com blog the-importance-of-

What is the FDA 1572 for?

The Form FDA 1572 is necessary to include in an initial IND submission and must be filled out when adding a new principal investigator at each site.

Is the FDA 1572 legally binding?

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. instructions for filling out form fda 1572 - statement of investigator fda.gov media download fda.gov media download

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

When should the Form FDA 1572 be completed and signed by the Principal Investigator? When a study is being conducted under an Investigational new drug application (IND). When an investigator is participating in a new protocol that has been added to the IND. Statement of Investigator Form. (Form FDA 1572). myscrs.org tcsqt forms myscrs.org tcsqt forms