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Click ‘Get Form’ to open it in the editor.
Begin by filling out Section 1 with your name and address as the Principal Investigator. Ensure all fields are completed accurately.
In Section 2, select one option that best describes your qualifications, either by providing a Curriculum Vitae or another statement of qualifications.
Proceed to Section 3 and enter the name and address of the medical school, hospital, or research facility where the clinical investigation will take place.
For Section 4, provide details about any clinical laboratory facilities that will be utilized during the study.
In Section 5, list the Institutional Review Board (IRB) responsible for reviewing and approving your study.
Complete Sections 6 through 9 by entering names of sub-investigators, protocol information, and commitments as outlined in each section.
Finally, sign and date the form in Section 10 before forwarding it to your sponsor for incorporation into an Investigational New Drug Application (IND).
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The Statement of Investigator, Form FDA 1572 (1572) is required for all clinical trials in which an Investigational New Drug (IND) application has been filed. The form provides the FDA and sponsors with information about qualifications of an investigator and their clinical site.
What is a FDA form 1572?
A form that must be filed by an investigator running a clinical trial to study a new drug or agent.
What is the FDA Form 1572 waiver?
A Form 1572 waiver allows a trial at a foreign site to take place under an IND even when the investigator cannot or will not sign the Form 1572, as noted above.
Can FDA Form 1572 be signed electronically?
WCM currently supports one system, docHub, which is 21 CFR Part 11 compliant and therefore can be used to collect signatures on informed consent forms and essential regulatory documents (i.e. FDA Form 1572, financial disclosure forms, delegation of authority logs, etc.) for FDA-regulated studies.
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INVESTIGATORS. SHOULD NOT SEND THIS FORM DIRECTLY TO THE FOOD AND DRUG ADMINISTRATION. INSTRUCTIONS FOR COMPLETING FORM FDA 1572. STATEMENT OF INVESTIGATOR. 10.
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