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Clinical Trial Request Form
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People also ask
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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. -
What is the 1572 form for clinical trials?
The Statement of Investigator, Form FDA 1572 (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 related to the conduct of a clinical investigation of an investigational drug or biologic. -
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 sponsor's authorizing representative should be entered and that individual must sign the form. -
What is the difference between FDA Form 3455 and 3454?
Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is signNow. -
What is the purpose of Form 1571?
The FDA Form 1571 or '1571' is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND. The 1571 is a contractual agreement between the sponsor and the FDA. -
What is a 3674 form?
Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions. -
What is pi 1572 form?
Form FDA 1572 has two purposes: 1) to provide the sponsor with information about the Principal Investigator's qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical ... -
What is purpose of FDA Form 1572?
The Statement of Investigator, Form FDA 1572 (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 related to the conduct of a clinical investigation of an investigational drug or biologic.
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