U.S. Food and Drug Administration (FDA) / HHS · United States

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Form FDA 1572: Statement of Investigator (21 CFR Part 312)

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JustFill is not affiliated with U.S. Food and Drug Administration (FDA) / HHS. This is an independent third-party tool to help you complete Form FDA 1572. Always download the current blank form from the official source and verify your completed copy before signing or submitting. Official Form FDA 1572 from U.S. Food and Drug Administration (FDA) / HHS

Quick answer

Form FDA 1572, Statement of Investigator (OMB No. 0910-0014, 21 CFR 312.53(c)), is the official 2-page U.S. Food and Drug Administration regulatory agreement signed by a clinical trial Principal Investigator (PI) and collected by the study Sponsor or Contract Research Organization (CRO) before the site may participate in an Investigational New Drug (IND) clinical study. Open the Form FDA 1572 blank in JustFill to complete Sections 1–10 in your browser or batch-populate multi-site study startup packets from CSV/Excel.

Form
Form FDA 1572
Issued by
U.S. Food and Drug Administration (FDA) / HHS
Country
United States
Free allowance
First clean download (up to 15 pages, filled by hand)
Official edition
Form FDA 1572 (OMB No. 0910-0014, 21 CFR 312.53(c), 2 pages)
1-Click Multi-PDF B2B Form Packet (Pro)Enter shared fields once → Generate 2–3 PDFs together

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1099 Contractor & Vendor Packet (W-9 + 1099-NEC)Vendor & AP · 2 Forms

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Shared fields: Contractor Name, Address, TIN, Payer Details, Box 1a Compensation

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US New Hire PacketHR & Payroll · 2 Forms

IRS Form W-4 + USCIS Form I-9

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1099 Contractor PacketVendor & AP · 2 Forms

IRS Form W-9 + IRS Form 1099-NEC (Copy B)

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CPA Tax PacketAccounting & Tax · 3 Forms

IRS Form 2848 (POA) + Form 8821 + Form 4506-T Transcript

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What is Form FDA 1572?

Running clinical trial site activation at a pharma sponsor, biotech company, Contract Research Organization (CRO), or academic medical center? Form FDA 1572 ("Statement of Investigator") legally binds the Principal Investigator (PI) to conduct the clinical investigation in accordance with the IND protocol and FDA Good Clinical Practice (GCP) regulations (21 CFR Parts 50, 54, 56, and 312), and records every physical research facility (Section 3), clinical laboratory (Section 4), Institutional Review Board / IRB (Section 5), and subinvestigator (Section 6). Because FDA’s official PDF uses restrictive XFA scripting that frequently breaks in browser viewers and eTMF systems, clinical regulatory specialists and site coordinators use JustFill to fill Form FDA 1572 online or batch-generate pre-populated 1572s across dozens of trial sites from a CTMS spreadsheet.

Download the Form FDA 1572 form PDF — free

The official Form FDA 1572 is published by the U.S. Food and Drug Administration at fda.gov/media/71955/download. Click "Fill the blank Form FDA 1572 now" above to open a clean, non-XFA 2-page fillable FDA 1572 directly in JustFill, or upload your site template to batch-populate multiple clinical sites from Excel/CSV.

Get the official Form FDA 1572 PDF from U.S. Food and Drug Administration (FDA) / HHS

Who fills out Form FDA 1572?

  • Principal Investigators (MDs, DOs, and PhDs) signing regulatory commitments for Phase 1, Phase 2, Phase 3, or Phase 4 IND clinical trials
  • Clinical Trial Associates (CTAs), Regulatory Startup Specialists, and Site Activation Managers at CROs and pharmaceutical/biotech sponsors preparing site regulatory packets
  • Clinical Research Coordinators (CRCs) at hospital research sites, oncology networks, and academic medical centers updating Section 4 labs or Section 6 subinvestigator rosters
  • Regulatory operations teams batch-generating Form FDA 1572 drafts from a Clinical Trial Management System (CTMS) Excel/CSV export

Field-by-field breakdown

What each section of Form FDA 1572 asks for. JustFill’s AI will detect these fields automatically when you upload the PDF — review the breakdown below so you know what to enter.

Sections 1 & 2 — Principal Investigator Name, Address & Qualifications

Full legal name and business address of the Principal Investigator (Section 1), plus a checkbox indicating whether a Curriculum Vitae (CV) or other statement of education, training, and experience is attached (Section 2).

Section 3 — Name & Address of Any Medical School, Hospital, or Research Facility

Exact legal name and physical street address of every clinical site or satellite clinic where study subjects will be seen or investigational drug administered.

Section 4 — Name & Address of Any Clinical Laboratory Facilities

Central and local clinical laboratories, imaging centers, pharmacokinetic (PK) labs, and pathology facilities used directly for protocol assessments.

Section 5 — Name & Address of the Institutional Review Board (IRB)

The central or local IRB (meeting 21 CFR Part 56 requirements) responsible for initial and continuing review and approval of the clinical study.

Section 6 — Names of the Subinvestigators

All subinvestigators (co-investigators, research fellows, study physicians, PAs, or NPs) who will directly assist the PI and make significant clinical trial decisions.

Sections 7–11 — Protocol Name/Code, Study Phase, Commitments, Signature & Date

Full protocol title and sponsor protocol number (Section 7), Phase 1 / Phase 2 / Phase 3 clinical protocol checkbox (Section 8), 21 CFR 312.53(c) investigator commitments (Section 9), and PI signature and date (Sections 10–11).

Common mistakes to avoid

  • 1Listing a P.O. Box or billing address in Section 3 instead of the exact physical street address where subjects are examined and investigational product is stored/administered.
  • 2Mismatching the Principal Investigator’s name in Section 1 against their medical license and attached Curriculum Vitae (CV).
  • 3Omitting local hospital labs used for STAT safety screening in Section 4, or listing every study nurse in Section 6 when FDA guidance specifies only subinvestigators making direct clinical/eligibility contributions.

Form FDA 1572 example — what a filled-out form looks like

A fictional oncology CRO regulatory specialist prepares Form FDA 1572 for a Phase 2 multicenter solid-tumor clinical trial site in Boston prior to site initiation.

Sections 1 & 2 — Principal Investigator & CV

PI: Elena V. Sample, MD · Address: 200 Brookline Medical Plaza, Suite 400, Boston, MA 02115 · Section 2: ☑ Curriculum Vitae attached

Sections 3 & 4 — Research Facility & Clinical Labs

Section 3: Sample Comprehensive Cancer Center, 200 Brookline Medical Plaza, Boston, MA 02115 · Section 4: Sample Central Bioanalytical Lab, 50 Science Park Dr, Research Triangle Park, NC 27709

Sections 5 & 6 — IRB & Subinvestigators

Section 5: Advarra / Central Oncology IRB, 6940 Columbia Gateway Dr, Suite 110, Columbia, MD 21046 · Section 6: Marcus Chen, MD; Priya Patel, NP

Sections 7, 8, 10 & 11 — Protocol, Phase & Signature

Section 7: Protocol ONC-2026-204 (A Phase 2 Study of SMB-401 in Advanced NSCLC) · Section 8: ☑ Phase 2, 3 clinical investigation · Signed: Elena V. Sample, MD · Date: 10/23/2026

These values are made up. They are here to show what belongs on each line, not to be copied — every name, number, and address on your own Form FDA 1572 has to be your own. Retain the signed Form FDA 1572 in the Investigator Site File (ISF) and Sponsor Trial Master File (eTMF) before shipping investigational product to the site.

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Frequently asked questions

The FDA’s downloadable Form 1572 uses legacy Adobe XFA technology, which displays a blank "Please wait..." page in browser PDF viewers and breaks many eTMF previewers. JustFill provides a standard AcroForm-compatible FDA 1572 that opens, edits, and exports cleanly in any browser.
Yes. In JustFill, regulatory startup teams can save Form FDA 1572 with common protocol, central lab (Section 4), and central IRB (Section 5) details, then upload an Excel/CSV site list to generate pre-filled 1572 PDFs for every Principal Investigator in one click.
No. The Principal Investigator signs and returns Form FDA 1572 to the study Sponsor (or CRO), who reviews it, retains it in the Trial Master File, and submits the required investigator information to the FDA in the IND submission.

Official source: Form FDA 1572 on U.S. Food and Drug Administration (FDA) / HHS’s website

Edition checked: Form FDA 1572 (OMB No. 0910-0014, 21 CFR 312.53(c), 2 pages). Verified against the official source on · Verified in our Government Forms Fillability Study.

JustFill is an independent product and is not affiliated with, endorsed by, or sponsored by U.S. Food and Drug Administration (FDA) / HHS or any government agency. Always verify your completed form on the official version before signing or submitting.