How to Fill Out FDA Form 1571 (w/Examples) + FAQs

FDA Form 1571 is the mandatory cover sheet for every submission to an Investigational New Drug (IND) application. Under 21 CFR 312.23, sponsors must submit this form with their initial IND and every subsequent amendment, report, or correspondence related to that IND. Failing to include a properly completed Form 1571 can delay your clinical trial or result in the FDA refusing to process your submission entirely.

The FDA’s Center for Drug Evaluation and Research (CDER) receives approximately 1,500 initial IND applications per year, with about 8.9% placed on clinical hold during the first 30 days after submission—most commonly due to chemistry, manufacturing, and controls (CMC) deficiencies. Understanding how to complete Form 1571 correctly is the first step toward avoiding these costly delays.​

In this article, you will learn:

📋 Every field on Form 1571 explained with real-world examples and consequences of errors

💊 The three IND types and two categories—and which one applies to your situation

⚠️ Common mistakes that trigger clinical holds and how to avoid them

📤 Electronic submission requirements through the FDA’s ESG portal

✅ Step-by-step guidance for initial submissions, amendments, and safety reports

What Is FDA Form 1571 and Why Does It Matter?

FDA Form 1571 serves two critical purposes under federal regulations. First, it functions as a legal agreement where the sponsor commits to conducting research according to all FDA regulations. Second, it acts as a cover sheet that identifies the contents of each submission to the IND file.​

The form must accompany the initial IND submission—which enables the sponsor to ship investigational drugs and begin clinical investigations—and every subsequent submission thereafter. Without proper completion of Form 1571, the FDA cannot process your application.​

The IND Types and Categories

The FDA recognizes three distinct IND types, each serving different purposes:

Beyond these types, INDs fall into two categories that determine eCTD submission requirements:

Commercial IND: Selected when the product is intended for eventual commercialization. Pharmaceutical companies and sponsors seeking market approval use this category. Commercial INDs require electronic submission in eCTD format through the FDA’s Electronic Submissions Gateway (ESG).

Research IND: Selected when the product is not intended for commercialization. Academic institutions, individual investigators, and non-profit entities typically use this category. Research INDs are exempt from eCTD requirements, though electronic submission is encouraged.

Field-by-Field Instructions for Form 1571

Fields 1-5: Sponsor Information

Field 1 (Select Appropriate Center): Choose either CDER (Center for Drug Evaluation and Research) for drugs or CBER (Center for Biologics Evaluation and Research) for biological products.​

Field 2 (Name of Sponsor): Enter the individual or organization taking responsibility for the clinical investigation. A sponsor-investigator is someone who both initiates and conducts the investigation. Important: If a pharmaceutical company supplies the drug but does not submit the IND, that company is not the sponsor.​

Field 3 (Date of Submission): Enter the date matching your cover letter. This date triggers the 30-day FDA review period before your study can begin.

Fields 4-5 (Address and Telephone): Provide the sponsor’s physical address. If using a P.O. Box, also include a street address on line 2.​

Fields 6-8: Drug and Indication Information

Field 6 (Name of Drug): List all available names including established name, trade name (if available), chemical name, and code designations. Include the dosage form and UNII (Unique Ingredient Identifier) term and code for active substances.​

Field 7A (IND Number): Leave blank for initial submissions. For subsequent submissions, enter the assigned IND number with leading zeros to make six digits (e.g., IND 12345 becomes 012345).​

Field 7B (IND Type): Select Commercial or Research based on the criteria discussed above. Critical consideration: When a sponsor that normally submits Research INDs submits a Phase 2 or Phase 3 protocol, they should select “Commercial” unless they submit a justification explaining why the study remains solely for research purposes.​

Field 8A (Proposed Indication for Use): State your proposed indication. Indicate if the indication involves a rare disease (prevalence below 200,000 U.S. patients). If you hold an Orphan Designation Number, select “Yes” and provide the six-digit number.​

Field 8B (SNOMED CT Disease Term): For original IND submissions, you must provide the coded disease term using the SNOMED CT browser. Navigate to browser.ihtsdotools.org, select the United States edition, search for your indication, and copy the Pre-coordinated Expression.​

Field 9: Phase of Clinical Investigation

Identify which phase(s) your investigation will conduct:

Field 10: Cross Reference

This section allows sponsors to reference information previously submitted to FDA rather than resubmitting identical data. Common cross-references include:​

• Drug Master Files (DMFs) for manufacturing information
• Another company’s IND for pharmacology/toxicology data
• Prior human experience data from other applications

Critical requirement: If the sponsor of the previously submitted information differs from the current sponsor, you must obtain a Letter of Authorization (LOA) granting FDA permission to reference that information.​

The only exception: When using a marketed drug without modifications to its approved packaging, simply identify the drug by trade name, established name, dosage form, strength, and lot number.​

Field 11: Serial Number

Serial numbers track all submissions to an IND. The numbering system follows strict consecutive ordering:​

Note the distinction: The serial number on Form 1571 differs from the eCTD sequence number. For initial submissions, the serial number is “0000” while the eCTD sequence number is “0001.”​

Field 12A: Submission Information

This critical field identifies the type of submission. For initial INDs, check only “Initial Investigational New Drug Application (IND).” For all subsequent submissions, check every applicable box because submissions often contain multiple information types.​

Common submission types include:

Protocol Amendments under 21 CFR 312.30:

• New Protocol: For studies not covered by existing protocols
• Change in Protocol: For modifications to existing protocols
• New Investigator: When adding investigators to carry out previously submitted protocols​

Information Amendments under 21 CFR 312.31: Select the applicable discipline—CMC, pharmacology/toxicology, clinical, statistics, or clinical pharmacology.​

IND Safety Reports under 21 CFR 312.32: Indicate whether you’re submitting an initial written report or follow-up report.​

Annual Report/DSUR: Required within 60 days of the IND anniversary date. The FDA now accepts Development Safety Update Reports (DSURs) in place of traditional annual reports.

Field 12B: Digital Health Technology Data

Select “Yes” if your submission contains DHT data or proposes collecting it. DHTs include activity trackers, mobile medical applications, and other remote data acquisition technologies.​

Field 13: Combination Products

Complete this field only for initial submissions. If your product combines drug-device, drug-biologic, or drug-device-biologic components, select “Yes” and enter the appropriate type number:

If you submitted a Request for Designation (RFD), provide the six-digit RFD number.​

Field 14: Justification Statement Requirements

Check this box only for expanded access submissions under 21 CFR 312.300. You must include a justification statement with applications for expanded access use. Contact the appropriate FDA review division before checking this box to discuss proposed treatment use.

Field 15: Contents of Application

This checklist indicates what documents accompany your submission. The 12 items correspond to 21 CFR 312.23 requirements:

Key note for Item 6: Completed Forms FDA 1572 with attachments satisfy Items 6 b-d (investigator data, facilities data, and IRB data).​

Key note for Item 7: When claiming categorical exclusion from environmental assessment, include: “I claim categorical exclusion (under 21 CFR 25.31(e)) for the study(ies) under this IND. To my knowledge, no extraordinary circumstances exist.”​

Fields 16-18: CRO and Responsible Personnel

Field 16 (Contract Research Organizations): Indicate if a CRO will conduct any portion of the study. If transferring sponsor obligations, use the Continuation Page to list the CRO’s name and address, identify the clinical study, and specify which obligations transfer.​

Field 17 (Monitor): Provide the name and title of the person responsible for monitoring conduct and progress of investigations. For sponsor-investigator INDs, the investigator typically holds this responsibility.​

Field 18 (Safety Reviewer): Provide the name(s) and title(s) of person(s) responsible for reviewing and evaluating safety information under 21 CFR 312.32.​

Fields 19-29: Signatures and Contact Information

Field 19: For sponsor-investigator INDs, enter the sponsor-investigator’s name. For company-sponsored INDs, enter the authorized representative’s name.​

Fields 20-24: Provide complete contact information including telephone, fax, mailing address, email, and signature date.

Field 23 (Email): For CBER submissions, include a statement in your cover letter authorizing non-secure email communication.​

Fields 25-29 (Countersigner): Required only when the person signing in Field 19 does not reside or have a place of business in the United States. A U.S.-based attorney, agent, or authorized official must countersign.​

Three Real-World Scenarios

Scenario 1: Academic Researcher Starting First-in-Human Study

Dr. Chen, a university researcher, wants to study a novel compound for treatment-resistant depression. She obtains the drug from a manufacturer who provides a Letter of Authorization to reference their Drug Master File.

Scenario 2: Pharmaceutical Company Submitting Commercial IND

BioPharm Inc. submits a Commercial IND for a new oncology treatment intended for eventual market approval.

Scenario 3: Physician Requesting Single Patient Expanded Access

Dr. Martinez needs to obtain an unapproved cancer drug for a critically ill patient who has exhausted all approved options.

Mistakes to Avoid

Mismatching serial numbers: Using incorrect serial numbering creates confusion and may delay processing. The initial IND is always Serial Number 0000, not 0001.​

Selecting wrong IND type: Choosing “Research” when you intend commercial development triggers eCTD requirements later. If FDA determines your Phase 2/3 protocol warrants commercial classification, you must convert—causing submission delays.​

Incomplete cross-references: Referencing another sponsor’s data without obtaining a Letter of Authorization results in FDA rejecting the cross-reference. You must then submit the data yourself or delay while obtaining authorization.​

Missing Form 1572s: Each principal investigator requires a completed Form 1572 submitted within 30 days of being added to the IND. Missing forms delay site activation.

Inconsistent dates: The date in Field 3 must match your cover letter date. Inconsistencies raise administrative red flags.​

Overlooking SNOMED CT requirement: Original IND submissions require the coded disease term. Failure to include this delays processing while FDA requests the information.​

Do’s and Don’ts

Do’s

✓ Do obtain your IND or Pre-IND number before submission. For CDER, request through the FDA NextGen Portal or via email. This number becomes your permanent IND number.​

✓ Do register for ESG access 2-4 weeks before your planned submission date. Account setup, testing, and troubleshooting take time.​

✓ Do maintain consecutive serial numbering across all submission types—amendments, reports, correspondence, and safety reports all use the same sequential numbering system.​

✓ Do submit protocol amendments before implementing protocol changes unless eliminating immediate hazards to subjects.​

✓ Do include a cover letter with every submission. Reference the IND number, serial number, and briefly describe the submission contents.​

Don’ts

✗ Don’t ship investigational drugs or begin clinical investigations until the IND is in effect. The IND goes into effect 30 days after FDA receipt or upon earlier FDA notification that the study may begin.​

✗ Don’t assume “no news is good news” during the 30-day review. While FDA often does not send formal “safe to proceed” letters, you must wait the full 30 days unless you receive earlier written authorization.​

✗ Don’t submit duplicate or conflicting information between Form 1571 and Form 1572. Data in these forms should align perfectly regarding investigators and sites.​

✗ Don’t forget annual reporting obligations. Submit an Annual Report or DSUR within 60 days of the IND anniversary date.​

✗ Don’t neglect to update Form 1572 when changing site information, IRB, laboratory, or clinical site locations. Submit updates within 30 days.​

Electronic Submission Requirements

Since May 2018, commercial INDs must be submitted in eCTD format through the FDA Electronic Submissions Gateway (ESG).​

ESG Account Setup Process

1. Create an FDA account through the Account Management portal
2. Request ESG access via FURLS (FDA Unified Registration and Listing System)
3. Choose connection method: AS2 Gateway (high-volume sponsors) or Unified Submission Portal (lower-volume)
4. Complete Trading Partner Agreement for AS2 connections
5. Send test submission to verify connectivity
6. Await FDA confirmation (typically 5-10 business days)​

Research IND Exemptions

Research INDs, investigator-sponsored INDs, and expanded access INDs are exempt from eCTD requirements. These sponsors may submit via email to the appropriate FDA division or through the ESG if preferred. CBER provides specific guidance in SOPP 8110 for eCTD-exempt submissions.

Key Supporting Forms

Form FDA 1572 (Statement of Investigator): A legal agreement where investigators commit to conducting research per FDA regulations. Required for each principal investigator at every site. Satisfies Items 6b-d on Form 1571.

Form FDA 3674 (Certification of Compliance): Certifies that applicable ClinicalTrials.gov registration and reporting requirements have been met. Include with IND submissions involving applicable clinical trials.​

Form FDA 3926: Simplified form specifically for single-patient expanded access requests. Physicians may use this instead of Forms 1571/1572 for individual patient compassionate use.​

FAQs

Can I submit Form 1571 without an IND number?
Yes. For initial IND submissions, leave Field 7A blank. FDA assigns the IND number upon receipt and communicates it in the acknowledgment letter.​

Does Form 1571 expire?
No. However, FDA periodically updates the form. Always download the current version from the FDA Forms page before submitting.​

Can I start my clinical trial during the 30-day FDA review?
No. You cannot ship investigational drugs or begin clinical investigations until the IND is in effect—either 30 days after FDA receipt or upon earlier FDA authorization.

Do I need Form 1571 for every submission to my IND?
Yes. Every submission to an IND—amendments, annual reports, safety reports, correspondence—must include a completed Form 1571 as the cover sheet.

Can IRB approval be obtained during the 30-day IND review period?
Yes. IRB approval and FDA review can proceed simultaneously. However, the study cannot begin until both the IRB approves and the IND is in effect.​

What happens if FDA places my IND on clinical hold?
No clinical investigation may proceed. FDA issues clinical holds when human subjects face unreasonable risk, investigators lack qualifications, or applications contain insufficient information. Resolve cited deficiencies before resuming.​

Is eCTD required for all INDs?
No. Research INDs, investigator-sponsored INDs, and expanded access INDs are exempt from eCTD requirements. However, all commercial INDs must use eCTD format.​

How long does ESG account setup take?
Plan 2-4 weeks. Account registration, trading partner agreement completion, connection testing, and FDA confirmation require adequate lead time before submission deadlines.​

Can I add investigators after the initial IND submission?
Yes. Submit a protocol amendment with the new investigator’s name, qualifications, and Form 1572 within 30 days of adding them.​

What is the most common reason for IND clinical holds?
Chemistry, manufacturing, and controls (CMC) deficiencies are most commonly cited, followed by clinical concerns and then toxicology issues.