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UUSOP-16: FORM FDA 1572

Version Date: June 25, 2025

  1. Introduction and Purpose
  2. Definitions and Acronyms
  3. Procedure
    1. Form FDA 1572 Template
    2. Completing Form FDA 1572 
    3. Updating Form FDA 1572 
    4. Non-IND Trials 
  4. Materials Required
  5. References
  6. Document Approval
  7. Revision History


Introduction and Purpose 

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. The form also informs the investigator of their obligations to the research that will be conducted, and serves as their signed commitment that they are qualified to conduct the research and will uphold their “Commitments” (see section 9 of the form).

The purpose of this SOP is to describe the process for completing and updating Form FDA 1572 for studies conducted at the University of Utah. 

 

Definitions and Acronyms 

Form FDA 1572: The Statement of Investigator 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.

Sub-investigator: A Sub-investigator is any other member (i.e., other than the Principal Investigator) of the study team who makes clinical decisions during the study. ICH GCP guidelines define Sub-Investigator as “Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trialrelated procedures and/or to make important trial-related decisions.”

Sponsor: The entity (i.e., individual, company, institution, or organization) that initiates a research project and bears direct responsibility for the overall conduct of the study. 

CFR: Code of Federal Regulations 
CRU: Clinical Research Unit 
CTSI: Clinical and Translational Science Institute 
FDA: United States Food and Drug Administration
GCP: Good Clinical Practice 
ICH: International Council on Harmonization 
PCH:  Primary Children’s Hospital 
PI: Principal Investigator
SOP: Standard Operating Procedure: An SOP is the principal document, which describes what is to be done, who is responsible for doing it, and when it is to be performed. If the instructions on how a procedure is to be performed are relatively simple, this may be incorporated into the SOP; otherwise, a separate Guidance Document/Work Practice Document should be created.

 

 

Procedure 

  1. Form FDA 1572 Template
    1. The current version of the form and instructions for filling out the form can be found at https://www.fda.gov/about-fda/reports-manuals-forms/forms (type “1572” in the search field). 
      1. A 1572 template may be provided by the sponsor that includes pre-filled information specific to a study.
    2. The expiration date can be found on the upper right-hand corner of the form and must be valid at the time of signature; except when the FDA has issued an extension for the expiration date.
    3. If the version of the completed form expires while the study is active, the form is not revised or updated to the new version until the information contained in the form changes. 
  2. Completing Form FDA 1572 
    1. Complete all required sections of the Form FDA 1572 according to the instructions provided by the FDA. Use a continuation page for each section requiring additional space. It is the responsibility of the PI to confirm that the information is correct. 
    2. For a few selected sections, additional instructions are provided below that are pertinent to the University of Utah.
    3. Section 3- Include the name and address of any facility where study procedures will be conducted, and where investigational product will be stored or administered. 
      1. Facilities such as the Clinical and Translational Science Institute’s (CTSI) Clinical Research Unit (CRU), investigational pharmacy, Primary Children’s Hospital (PCH), outlying University clinics (e.g. Sugarhouse, South Jordan), and all other locations where participants are seen for the study should be listed in this section.
      2. If participants are seen at multiple locations within the main University Hospital (50 North Medical Drive), it is not necessary to list each location within the hospital individually.
      3. If participants are seen at home, participant addresses must not be listed on the 1572. 
    4.  Section 4- Include the name and address of any laboratory or testing facility that is directly supporting the clinical research. This should include any local laboratories used to collect, process, or ship study samples, and may also include diagnostic laboratories or imaging facilities.
      1. Only the main ARUP laboratory location (500 Chipeta Way, Salt Lake City, UT 84108) should be included, as applicable. All other ARUP locations do not need to be listed individually. 
    5. Section 6- Only those who have a permanent and specific role in the clinical trial and are directly involved in the treatment and evaluation of research participants will be listed. For example, physicians, PhD faculty, and mid-level providers such as Physician Assistants and Nurse Practitioners are included.
      1. Clinical research staff (Research Managers, Clinical Research Coordinators, Research Nurses, Study Coordinators, and Research Assistants) do not need to be included.
      2. Ancillary research personnel such as regulatory staff, nurses, residents, pharmacists, pharmacy technicians, infusion personnel, and office staff will not be included.   
  3. Updating Form FDA 1572 
    1. The 1572 must be updated when a new principal investigator is added to an ongoing trial, or when an investigator is participating in a new protocol under an existing IND.
      1. Removal or addition of sub-investigators, addition of a clinical research lab, or IRB address changes do not require an updated 1572. These changes should be documented in the study record and communicated to the sponsor, who will update the IND accordingly. This communication should be filed in the regulatory binder as important correspondence.
      2. A new 1572 does not need to be prepared or signed when the OMB expiration date on the form has been reached.
    2. When an updated form is signed, the previous form is no longer valid, but must remain filed in the regulatory binder for the study. 
  4. Non-IND Trials  
    1. A 1572 should not be utilized for studies that are not conducted under an IND. 

Materials Required 

References 

Document Approval 

Erin Rothwell, Ph.D. 
Vice President for Research, University of Utah
Date: 07/17/2025

 

Revision History 

Version Date

Change Summary

25Jun2025

Original Version

dd/mm/yyyy

 

 

Printed or photocopied versions are considered unofficial copies unless it is the original signed document.
Last Updated: 7/18/25