FDA 1572 Statement of Investigator - ccrod cancer-2025

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  1. Click ‘Get Form’ to open the FDA 1572 Statement of Investigator in the editor.
  2. Begin by filling in your name and address as the Principal Investigator. Ensure all details are accurate, including your building and room number.
  3. In Section 2, select either 'Curriculum Vitae' or 'Other Statement of Qualifications' to demonstrate your expertise in clinical investigations.
  4. Provide the name and address of the medical school or research facility where the investigation will take place in Section 3.
  5. For Section 4, list any clinical laboratory facilities that will be used during the study, ensuring to include complete addresses.
  6. In Section 5, enter the name and address of the Institutional Review Board (IRB) responsible for approving your study.
  7. Complete Sections 6 through 9 by providing names of sub-investigators, protocol information, and commitments as outlined in each section.
  8. Finally, sign and date the form at the bottom before forwarding it to your sponsor for incorporation into an Investigational New Drug Application (IND).

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Block 2: A copy of the CV for the Overall PI should accompany the 1572 form. The CV (or other statement of qualifications) must demonstrate the education, training and experience that qualify the investigator as an expert in the clinical investigation of the drug/biologic for the use under investigation.
Should I complete the Form FDA 1572 if the study is not under an IND? and so studies that are not done under an IND or if they are investigational device studies,(these are conducted under and IDE), do not require a Form FDA 1572 to be completed and signed.
There are two instances where the investigator must complete and sign a new 1572: When a new protocol is added and the investigator must employ that protocol. When a new investigator is added to the investigation(21 CFR 312.53(c))
It is a signed agreement from the Investigator (i.e., Principal Investigator) that he/she will conduct the research in compliance with FDA regulations.
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