FDA Form 1572, Statement of Investigator Instructions

Enter the full name of the clinical laboratory facility to be used in the study.

Enter the facility's primary street address or P.O. box (address line 1).

Enter the facility's secondary address information such as suite, floor, building, or unit number (address line 2).

Enter the city and the state, province, or region where the facility is located (for example: 'Boston, MA').

Enter the country and the ZIP or postal code for the facility (for example: 'United States, 02115').

Enter the full official name of the Institutional Review Board (IRB) responsible for review and approval of the study.

Enter the primary street address or P.O. box for the IRB (Address 1).

Enter additional address details such as suite, floor, building name, or other secondary address information (Address 2).

Enter the city and the state/province/region for the IRB's address in this field.

Enter the country and the ZIP or postal code for the IRB's address in this field.

Enter the investigator's full name and primary mailing address on a single line.

Enter the clinical investigator's full name (given name, middle initial(s) if used, and family name).

Enter the first line of the investigator's street address (street number and name, P.O. box, or similar).

Enter the second address line for additional location details such as apartment, suite, building, or department.

Enter the city for the investigator's mailing address.

Enter the country for the investigator's mailing address (for example, United States).

Enter the primary street address of the medical school, hospital, or research facility where the clinical investigation will be conducted (street number, street name, and, if applicable, building).

Provide any secondary address information for the facility such as apartment, suite, floor, or other additional location details.

Enter the city or locality of the medical school, hospital, or research facility.

Enter the ZIP or postal code for the facility's address exactly as used by the local postal service.

Enter the date the investigator signed this form in mm/dd/yyyy format.

Provide the investigator’s handwritten or electronic signature exactly as they wish it to appear on the form.

Enter the investigator’s printed full name and/or professional title or credentials associated with the signature.

Enter the full name(s) of the protocol(s) and any assigned code or protocol number(s) for the investigational new drug (IND) associated with the study to be conducted by the investigator; list multiple protocols separated by commas or semicolons.