FDA Form 1571: The IND Cover Sheet Explained

Form FDA 1571 is the cover sheet required for every submission made to the FDA under an Investigational New Drug (IND) application — not just the initial filing. It identifies the sponsor, the drug, the phase of investigation, and the contents of the specific package being submitted, and it is the document the sponsor (or a sponsor-investigator) signs to formally take on the regulatory responsibilities of an IND sponsor under 21 CFR Part 312. It is a required administrative wrapper, not a substitute for the substantive content — chemistry/manufacturing/control data, nonclinical pharmacology and toxicology data, the protocol, and the investigator’s brochure — that 21 CFR 312.23 actually requires an IND to contain.

What Form 1571 Is For

An IND application authorizes a sponsor to ship an investigational drug or biologic across state lines and administer it to human subjects before the product has FDA marketing approval, under 21 CFR 312.23. Form 1571 sits at the front of that application — and every subsequent submission tied to it — and serves three functions at once:

Identification. It states who the sponsor is, the drug’s name and identifying information, and which IND number the submission belongs to (left blank on the very first, original submission, since FDA assigns the number upon receipt).
Certification. By signing it, the sponsor agrees to comply with all applicable IND regulations, including not beginning clinical investigations until 30 days after FDA receives the IND (unless notified sooner) and not making the drug commercially available during the investigation.
A table of contents for that specific submission. The form includes a checklist of what the package contains — protocol, investigator’s brochure, chemistry/manufacturing data, an annual report, a safety report, and so on — so FDA reviewers can quickly see what they’re looking at without opening the full package first.

Who Files It: Sponsor vs. Sponsor-Investigator

Under 21 CFR 312.3, the sponsor is the entity that takes responsibility for and initiates a clinical investigation — this can be a pharmaceutical company, a government agency, an academic institution, or another organization. A sponsor-investigator is an individual who both initiates and personally conducts the investigation, most commonly an academic researcher running an investigator-initiated trial under their own IND rather than a company’s. Form 1571 is completed and signed the same way in either case, but the sponsor-investigator scenario is where research administrators most often get pulled in directly, since the individual filing typically doesn’t have a regulatory affairs department handling submissions for them. See CASRAI’s guide to clinical trial phases for where an IND fits into the overall development timeline, and the dictionary entry on the Principal Investigator role for how that role relates to (but is distinct from) the sponsor-investigator designation.

When Form 1571 Is Required

A completed Form 1571 must accompany:

The original IND submission — the initial filing that opens the IND and, if FDA does not place it on clinical hold within 30 days, allows the proposed study to proceed.
Every subsequent submission made under that IND for the life of the study — protocol amendments, information amendments, annual reports, safety reports (including expedited IND safety reports), and general correspondence.

Each submission gets a new, sequential serial number recorded on the form: the original IND is Serial Number 0000, the next submission of any kind is 0001, the one after that is 0002, and so on, counting up consecutively for the life of the IND regardless of submission type. This serial number — not the calendar date — is how FDA and the sponsor both track and reference the submission history of a given IND.

What Form 1571 Requires You to Provide

The form’s fields fall into a few functional groups (exact item numbers have shifted slightly across form revisions, so treat these as the categories rather than a fixed numbering):

Sponsor identification and contact information — name, address, and telephone number of the sponsor or sponsor-investigator, plus the name and title of the person(s) responsible for monitoring the study and reviewing incoming safety data.
Drug identification — the proprietary and/or established name of the investigational drug, its dosage form(s), and route of administration.
IND number and serial number — the IND number (blank on the original submission), and the serial number described above.
Indication(s) and phase(s) — the disease or condition to be studied and which phase or phases of investigation (Phase 1, 2, or 3) the submission covers.
IND type — whether this is a commercial or research (noncommercial) IND, and if applicable, an emergency use IND or treatment IND.
Contents checklist — a list of what’s enclosed in this specific submission (protocol, investigator’s brochure, chemistry/manufacturing/controls information, pharmacology/toxicology information, previous human experience, and so on), keyed to the 21 CFR 312.23 content requirements.
Signature and certification — the sponsor’s (or authorized representative’s) signature, attesting to compliance with applicable IND regulations.

The definitive, field-by-field walkthrough is FDA’s own instruction sheet accompanying the form and its companion guidance, How to Complete Form FDA 1571 and Form FDA 1572 — always work from the current form revision on FDA’s own IND Forms and Instructions page rather than a saved copy, since FDA periodically reissues the form with revised item numbering.

How Form 1571 Relates to the Rest of the IND Application

Form 1571 is the cover sheet, not the application itself. The substantive content requirements for an IND are set out in 21 CFR 312.23 and include an introductory statement and general investigational plan, the investigator’s brochure, the protocol, chemistry/manufacturing/control (CMC) information, pharmacology and toxicology data, and any previous human experience with the drug. Form 1571 simply identifies and indexes that package for the reviewing division. A separate form, Form FDA 1572 (Statement of Investigator), is completed by each individual investigator at a study site (not the sponsor) and should not be confused with 1571 — 1571 is the sponsor’s submission cover sheet, 1572 is the investigator’s site-level commitment statement. Sponsors of certain drug and biologic INDs may also need Form FDA 3674, certifying compliance with the ClinicalTrials.gov registration requirements of FDAAA 801.

Electronic Submission and eCTD

Since May 2018, FDA has required commercial IND submissions to be filed electronically in eCTD (electronic Common Technical Document) format. Noncommercial INDs — including most investigator-sponsored and research INDs — are exempt from that mandate, but FDA encourages electronic, eCTD-formatted submission for these as well, and many academic sponsor-investigators now submit through FDA’s electronic gateway regardless of whether it’s strictly required. A research administrator supporting a sponsor-investigator IND should confirm current submission channel requirements directly on FDA’s eCTD page before assuming paper/triplicate submission is still an option, since FDA has continued to narrow the exemptions over time.

Common Mistakes

Reusing an old serial number or skipping one. Every submission needs the next sequential serial number; gaps or duplicates create confusion in FDA’s tracking and can delay processing.
Treating Form 1571 as the whole application. A completed 1571 with a thin or missing CMC/protocol/investigator’s brochure package behind it does not satisfy 21 CFR 312.23 — the form is an index, not a replacement for the required content.
Confusing 1571 with 1572. Sponsor-level cover sheet vs. site-investigator statement of commitment — different form, different signer, different purpose.
Leaving the phase/indication fields vague. FDA’s reviewing division assignment and review timeline depend on accurately identifying the phase and therapeutic area being studied.
Missing the 30-day clock. Signing Form 1571 certifies the sponsor’s understanding that clinical investigations may not begin until 30 calendar days after FDA receives the IND, unless FDA notifies the sponsor sooner that the study may proceed — plan site activation timelines accordingly.

Frequently Asked Questions

Does Form 1571 need to be submitted every time, or just once at the start of an IND?

Every time. A new Form 1571 accompanies every submission made under an IND for its entire life — the original filing plus every amendment, annual report, safety report, and item of correspondence — each carrying its own sequential serial number.

Who signs Form 1571?

The sponsor or, for a sponsor-investigator IND, the individual investigator acting as sponsor. It cannot be signed on the sponsor’s behalf by someone without documented authority to do so.

What’s the difference between Form FDA 1571 and Form FDA 1572?

Form 1571 is the sponsor’s cover sheet for the IND submission as a whole. Form 1572 (Statement of Investigator) is completed separately by each investigator at each study site, committing them to conduct the study according to the protocol and applicable regulations. A multi-site trial will have one 1571 per submission but potentially many 1572s, one per site investigator.

Is Form 1571 required for a Phase 1 investigator-initiated trial at an academic medical center?

Yes. Any IND — commercial, research, or sponsor-investigator — requires a Form 1571 with every submission, regardless of phase or sponsor type. What differs for a noncommercial/investigator-sponsored IND is that the eCTD electronic-format mandate does not apply, though electronic submission is still encouraged.

Where do I get the current version of Form 1571?

Always download the current version directly from FDA’s own IND Forms and Instructions page rather than reusing an institutional template, since FDA periodically reissues the form and item numbering can shift between revisions.