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FDA Form 1572, Statement of Investigator, page 1
Basic · 37/100Form Complexity Index

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What this form asks for

The AI fills all of it, from your answers or your documents.

FDA Form 1572, Statement of Investigator, is a U.S. Food and Drug Administration form completed by a clinical investigator participating in a drug study conducted under an Investigational New Drug (IND) application. It captures essential details such as the investigator’s name and address, the research facility, clinical laboratory, IRB information, and the protocol name(s)/code number(s), and it includes the investigator’s signature and date to confirm regulatory commitments. Sponsors rely on this form to document investigator qualifications and oversight arrangements and to support compliance with FDA regulations during inspections and audits. Today, this form can be filled out quickly and accurately using AI-powered services like Instafill.ai, which can also convert non-fillable PDF versions into interactive fillable forms.
Fillable fields24
Pages2
Sections6
Form Complexity IndexBasic, 37/100

The AI checks your answers before you download

16 checks built for this form, so a wrong date or a missing answer is caught before anyone else sees it.

Investigator full name completeness and structure (Item 1 — Name of Clinical Investigator)

Validates that the investigator name is present and appears to be a full legal name, including at least a given name and family name, with optional middle initial(s). This reduces ambiguity and ensures the signer can be uniquely identified for regulatory and audit purposes. If the field is missing or contains only a single token (e.g., just a last name), the submission should be rejected or flagged for correction.

Item 1 single-line name/address matches component fields

Checks that the single-line 'Name and Mailing Address' field is consistent with the separately captured investigator name and address components (name, address line 1/2, city, country). This prevents conflicting records where the single-line entry differs from the structured fields used for downstream processing and mailings. If mismatches exceed minor formatting differences (e.g., punctuation), the system should require reconciliation before acceptance.

Investigator mailing address minimum required elements (Item 1 address fields)

Ensures the investigator mailing address includes required elements: Address Line 1, City, and Country (and Address Line 2 only if applicable). A complete address is necessary for official correspondence and verification. If any required element is missing or blank, the form should fail validation and prompt the user to complete the address.

Address Line 1 format validation (street/P.O. box) for all address blocks

Validates that Address Line 1 for the investigator, facility (Item 3), laboratory (Item 4), and IRB (Item 5) contains a plausible deliverable location (e.g., street number + street name, or a P.O. Box) and is not only a building name or department. This improves deliverability and reduces returned mail and data quality issues. If Address Line 1 lacks key address indicators (e.g., no number and no 'PO Box'), the submission should be flagged for correction.

City field validation (no invalid characters; not empty where required)

Checks that city/locality fields (Item 1 City, Item 3 City, and the city portion of Items 4 and 5 combined fields) are populated where required and contain only valid characters (letters, spaces, hyphens, apostrophes). This prevents parsing failures and ensures consistent geographic data for reporting. If the city is missing or contains clearly invalid content (e.g., only numbers or symbols), validation should fail.

Country field normalization and allowed values (Items 1, 4, 5)

Validates that country entries are present where required and match an approved country list (e.g., ISO-3166 names) or can be reliably normalized (e.g., 'USA' → 'United States'). Standardized country values are important for regulatory routing, address validation, and analytics. If the country cannot be mapped to an allowed value, the submission should be rejected or require user selection from a controlled list.

And 10 more checks
  • ZIP/Postal code format validation (Item 3; Items 4 and 5 combined fields)
  • City/State or Province combined field parsing and validation (Items 4 and 5)
  • Country and ZIP/Postal combined field parsing and validation (Items 4 and 5)
  • Clinical laboratory facility name required and non-generic (Item 4)
  • IRB name required and non-placeholder (Item 5 - IRB Name)
  • Protocol name(s) and code number(s) presence and delimiter rules (Item 7)
  • Protocol entry quality check (detect missing name or missing code when expected)
  • Signature presence and signature-to-printed-name consistency (Page 2)
  • Signature date format and validity (Page 2 — Date)
  • Signature date logical reasonableness (not in the future; not unreasonably old)

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How to Fill Out FDA 1572 Online for Free in 2026

What the AI walks you through.

  1. Go to Instafill.ai and upload the FDA Form 1572 PDF (or select it from the form library).
  2. Let the AI detect the form fields and confirm the form version, then choose whether to import data from a profile, CV, or prior 1572.
  3. Enter or verify Item 1 (Clinical Investigator name and mailing address), ensuring spelling and address formatting are correct.
  4. Complete the study location details, including Item 3 (medical school/hospital/research facility address) and Item 4 (clinical laboratory facility name and address).
  5. Provide Item 5 (IRB name and address) and Item 7 (protocol name(s) and code number(s)), checking for consistency with the protocol/IND documentation.
  6. Review the auto-filled output for completeness, then add the investigator’s signature, printed name/title, and the signature date on page 2.
  7. Run final validation, export the completed form as a signed PDF, and share/download it for sponsor submission and records.

Common Mistakes in Completing FDA 1572

The ones the AI is built to catch.

Using the single-line Item 1 field but omitting required address parts
People often type only the investigator’s name (or only the address) into the “Name and Mailing Address (single line)” field because it looks like a simple header line. This can result in an incomplete mailing address, causing delays in correspondence or rejection for missing required contact information. If you use the single-line option, include the full name plus complete mailing address in one continuous line (street/PO box, city, and country as applicable). AI-powered tools like Instafill.ai can help by validating that all required components are present even when entered in a single line.
Inconsistent investigator name across Item 1 fields
A common error is entering different versions of the investigator’s name across fields (e.g., “Bob Smith” in one place and “Robert J. Smith, MD” in another). This happens when people copy from email signatures or prior documents without standardizing the legal/professional name format. Inconsistencies can trigger verification issues, questions from reviewers, or mismatches with regulatory records. Use one consistent full name format (given name, middle initial(s) if used, family name) and keep credentials/titles only where requested; Instafill.ai can standardize names across repeated fields.
Putting suite/department details in Address Line 1 instead of Address Line 2
Many submitters cram all address details into Address Line 1, including suite, floor, building, or department, because they’re unsure what Address Line 2 is for. This can lead to formatting problems, truncated lines, or mail delivery issues if the system has character limits. Enter the street number and street name (or PO box) in Address Line 1 and put suite/floor/building/department in Address Line 2. Instafill.ai can automatically split and format addresses into the correct lines.
Missing or incorrect country entry for mailing addresses
People frequently leave the Country field blank (especially for domestic addresses) or use non-standard abbreviations that don’t match postal conventions. This happens because some forms don’t always require country for local mail, but this form explicitly asks for it in multiple sections. Missing/incorrect country information can cause routing errors and follow-up requests from reviewers. Always enter the full country name (e.g., “United States”) and keep it consistent; Instafill.ai can enforce standardized country values.
Mixing investigator, research facility, lab, and IRB addresses
Because Items 1, 3, 4, and 5 all request names and addresses, it’s common to accidentally paste the wrong organization’s address into the wrong section. This often happens when users copy from a single source document or reuse a previous submission without carefully checking each item label. The consequence is misidentification of the study site, lab, or IRB, which can create compliance concerns and delay approvals. Double-check each item’s purpose (investigator mailing address vs. study facility vs. lab vs. IRB), and consider using Instafill.ai to map data to the correct fields and flag mismatches.
Incorrect formatting for “City and State/Province/Region” combined fields
For Items 4 and 5, the form expects a combined entry like “Boston, MA,” but people often enter only the city, only the state, or use inconsistent separators (e.g., “Boston MA” or “MA - Boston”). This happens because other address sections split city and state into separate fields, so users assume the same here. Incorrect formatting can cause address standardization failures and manual clarification requests. Follow the example exactly (City, space, State/Province/Region) and let Instafill.ai format combined location fields correctly.
Entering ZIP/postal codes in the wrong format or using the wrong code
Users sometimes enter a ZIP+4 when the system expects a 5-digit ZIP, omit required characters for international postal codes, or accidentally use the investigator’s ZIP for the facility/IRB. This typically occurs when copying addresses from templates or when multiple sites share similar city/state information. Wrong postal codes can lead to returned mail and can raise questions about the accuracy of site information. Use the exact ZIP/postal code used by the local postal service for each specific address; Instafill.ai can validate postal code formats by country and reduce copy/paste mix-ups.
Using informal or incomplete facility/IRB names instead of official legal names
A frequent mistake is entering shorthand names (e.g., “General Hospital Lab” or “University IRB”) rather than the full official entity name. This happens because staff often use internal nicknames or abbreviations in daily communication. The consequence is ambiguity about which lab or IRB is responsible, which can delay review or require resubmission with corrected legal names. Enter the full official name as it appears on institutional documentation; Instafill.ai can store and reuse verified organization names to keep them consistent.
Not listing multiple protocols correctly in Item 7
When there are multiple protocols, people often list only one, forget the code numbers, or separate them with line breaks instead of commas/semicolons as instructed. This happens because users treat the field like a narrative description rather than a structured list. Missing or poorly separated protocol identifiers can cause confusion about which IND protocols the investigator is committing to and may trigger follow-up queries. Include each protocol name with its code/number and separate multiple entries with commas or semicolons; Instafill.ai can help format multi-protocol lists consistently.
Wrong date format or using the completion date instead of the signature date
Many people enter dates in dd/mm/yyyy (common outside the U.S.), write out the month (e.g., “13 Feb 2026”), or use the date the form was prepared rather than the date it was signed. This happens due to regional date habits and because forms are often drafted before signature. Incorrect dates can invalidate the attestation timing and lead to requests for correction or re-signature. Enter the investigator signature date in mm/dd/yyyy exactly; Instafill.ai can enforce date formatting and prompt for the correct “signed on” date.
Signature and printed name/title mismatch or missing credentials
A common issue is providing a signature that doesn’t match the printed name (e.g., signing with initials or a nickname) or leaving the printed name/title blank. This happens when the signer assumes the signature alone is sufficient or when someone else prepares the form and forgets to complete the printed name/title line. Mismatches can create identity verification problems and may require re-execution of the signature page. Ensure the signature corresponds to the printed full name and include the professional title/credentials as requested; Instafill.ai can cross-check the printed name against the entered investigator name to reduce discrepancies.

Frequently Asked Questions About FDA 1572

 

Is it really free for 7 days?
Yes. You pay $0 today. Cancel before Nov 17 and you are never charged. Keep it, and it is $19.99 a month for 5 fills of your FDA 1572.
Can I fill other forms too?
This plan is for your FDA 1572: your own AI agent fills it as often as 5 times a month. To fill other forms and upload your own, choose a Professional plan from your account.
How do I cancel?
From your account, in two clicks, any time. No email, no call.
How does the AI fill out FDA 1572?
You answer a few questions in plain words, or upload a document you already have. The AI reads what you give it and puts each answer into the right field of FDA 1572, on every page, in seconds. It checks the answers against the form's own rules, and you review and change anything before you download, print or sign.
What happens to my information?
It is encrypted in transit and at rest, and it is never used to train AI.
How complex is FDA 1572 to fill out?
FDA 1572 has a Form Complexity Index of 37 out of 100, in the basic tier: 24 fillable fields across 2 pages. Instafill.ai's AI fills it in under a minute, with every field there for you to review before you download.
What is the purpose of this form?
This form captures the clinical investigator’s identity and key study site details (research facility, lab, and IRB) along with the protocol name/code and the investigator’s signature/date. It is typically used to document who is conducting the clinical investigation and where oversight and testing will occur.
Who needs to fill out and sign this form?
The clinical investigator (the person responsible for conducting the study at the site) should complete the investigator information and sign/date the form. Site staff may help prepare addresses and protocol details, but the investigator should review for accuracy before signing.
What information do I need before I start filling it out?
Have the investigator’s full legal name and mailing address, the research facility address, the clinical laboratory name/address, the IRB’s official name/address, and the protocol name(s) and code number(s). You’ll also need the signature date in mm/dd/yyyy format.
Item 1 asks for “Name and Mailing Address (single line)” and also separate name/address fields—do I fill out both?
If the form provides both a single-line field and separate fields, follow the form’s instructions or your sponsor’s preference—often the separate fields are used for clarity and the single-line field may auto-populate or be optional. If unsure, complete the separate fields and ensure the single-line entry matches exactly.
How should I format the investigator’s name in Item 1?
Enter the investigator’s full name as given name, middle initial(s) if used, and family name. Use the same name format consistently across the signature and printed name/title fields.
What should I put in Address Line 2 for Item 1, Item 3, Item 4, or Item 5?
Use Address Line 2 for secondary details like apartment, suite, floor, building, department, or mail stop. If there are no additional details, you can leave Address Line 2 blank.
What address should I use for Item 3 (Medical School / Research Facility)?
Use the physical location where the clinical investigation will be conducted (e.g., hospital, clinic, or research facility). Include the street address and any building/floor/suite details so the site can be clearly identified.
How do I complete Item 4 (Clinical Laboratory Facility) if multiple labs are used?
This form appears to provide space for one lab name/address; if multiple labs are involved, list the primary lab here and follow sponsor instructions for adding additional labs (e.g., attach a separate sheet or provide an addendum). Make sure the lab listed matches the study’s lab arrangements.
What should I enter for Item 5 (IRB Name and Address)?
Enter the IRB’s full official name and its mailing address (street/P.O. box, city/state or province/region, country, and ZIP/postal code). Use the IRB information exactly as it appears on IRB documentation to avoid delays.
How do I list multiple protocols in Item 7 (Protocol Name(s) and Code Number(s))?
Enter each protocol’s full name and its code/protocol number, separating multiple entries with commas or semicolons. Keep the names and numbers exactly as provided by the sponsor/IND documentation.
What date format is required on Page 2?
Use mm/dd/yyyy (for example, 02/13/2026). The date should reflect when the investigator actually signed the form.
Can the investigator use an electronic signature, or does it have to be handwritten?
The signature field allows handwritten or electronic signature, as long as it is the investigator’s signature and is applied according to your organization’s and sponsor’s requirements. Confirm any specific e-signature rules with the sponsor or regulatory team.
What should be included in “Investigator’s printed name / title”?
Enter the investigator’s printed full name and, if applicable, professional title/credentials (e.g., MD, PhD). This should match the signer and help clearly identify the investigator.
Can AI tools help me fill out this form accurately?
Yes—AI form-filling tools can help reduce manual typing and errors by auto-filling fields from your provided information. Services like Instafill.ai use AI to map your details to the correct form fields and save time.
How can I fill this form online using Instafill.ai, and what if the PDF isn’t fillable?
Upload the PDF to Instafill.ai, provide or import the investigator/site/IRB/lab details, and let the AI auto-fill the matching fields for review before downloading. If the PDF is flat/non-fillable, Instafill.ai can convert it into an interactive fillable form so you can complete and sign it more easily.
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