Form FDA 1571: what you certify each time you sign the IND cover sheet

At a glance

• Form FDA 1571 is the cover sheet that 21 CFR 312.23(a)(1) requires at the front of an IND.
• Each signature repeats three commitments: not to begin clinical investigations until the IND is in effect, to have a Part 56 IRB review and approve each study, and to follow all other applicable regulatory requirements.
• The form lists every kind of IND submission in item 12A, from the initial IND to protocol amendments, safety reports, annual reports and responses to a clinical hold, so the same form fronts the IND for as long as it is open.
• The sponsor or the sponsor’s authorized representative signs it. A signer outside the United States needs a US countersigner.
• The current edition on fda.gov is Form FDA 1571 (05/26), OMB No. 0910-0014, with an expiration date of 31 July 2027 (checked 29 October 2026).

Form FDA 1571 is the Investigational New Drug Application form: the signed cover sheet a sponsor puts on the front of an IND submission to FDA. Most people meet it once, on the initial IND, and treat it as an application form to fill in. It is used far more often than that. The same form goes on the front of every later submission to the IND, and every time someone signs it, they repeat the commitments in the regulation. This guide covers those commitments, the fields that cause trouble, which box to tick, and how to tell whether your copy is current.

What Form FDA 1571 is

21 CFR 312.23(a)(1) lists the contents of the IND cover sheet and names it “Form FDA-1571”. It is the first item in the IND, ahead of the table of contents, the investigational plan, the investigator’s brochure, the protocols and the technical sections (312.23(a)). What the rest of the IND must contain is covered in our guide to the FDA IND application. For where the cover sheet sits in the regulation as a whole, see the 21 CFR 312 map.

Each submission relating to an IND must be numbered serially, starting from the initial IND (312.23(e)). The form records that serial number in item 11, and its list of submission types in item 12A shows how long the form stays in use: from the initial IND to the last annual report.

What you certify when you sign

The cover sheet must contain three commitments (312.23(a)(1)(iii) to (v)):

1. A commitment not to begin clinical investigations until an IND covering them is in effect.
2. A commitment that an IRB complying with Part 56 will be responsible for the initial and continuing review and approval of each study, and that the investigator will report proposed changes in the research activity to the IRB in accordance with Part 56.
3. A commitment to conduct the investigation in accordance with all other applicable regulatory requirements.

The first commitment ties to the 30-day rule. An IND goes into effect 30 days after FDA receives it, unless FDA notifies the sponsor of a clinical hold, or earlier if FDA notifies the sponsor that the investigations may begin (312.40(b)). How that clock runs is covered in there is no FDA IND database.

The third commitment is wider than it looks. “All other applicable regulatory requirements” includes the sponsor duties in Subpart D of Part 312. Sponsors are responsible for selecting qualified investigators, ensuring proper monitoring, maintaining an effective IND, and ensuring FDA and all investigators are promptly informed of significant new adverse effects or risks (312.50).

The form’s wording is not the regulation’s wording. The printed statement above item 19 on the 05/26 edition reads as an agreement not to begin clinical investigations until 30 days after FDA’s receipt of the IND unless FDA gives earlier notice, and not to begin or continue studies placed on “clinical hold or financial hold”. The regulation frames the commitment as not beginning until the IND is in effect (312.23(a)(1)(iii)). “Financial hold” does not appear in Part 312. The printed statement also leaves out the part of 312.23(a)(1)(iv) about the investigator reporting proposed changes to the IRB. The signature on the form is a signature to the regulation’s commitments as well as the printed ones, so read both.

Sponsor-investigators sign as sponsors. A sponsor-investigator is an individual who both initiates and conducts an investigation, and carries the requirements for both an investigator and a sponsor (312.3(b)). An academic PI who signs the 1571 for their own IND is taking on the sponsor commitments personally. FDA’s form instructions (6/24 edition) add that only one individual should be designated as sponsor-investigator, and that a company supplying the drug without submitting the IND is not the sponsor. The investigator-initiated trials guide covers the wider sponsor-investigator role.

Who signs, and who countersigns

The cover sheet must carry the signature of the sponsor or the sponsor’s authorized representative (312.23(a)(1)(ix)). If the person signing does not reside or have a place of business in the United States, the IND must also contain the name and address of, and be countersigned by, an attorney, agent or other authorized official who does (312.23(a)(1)(ix)). Items 19 to 24 and 28 on the 05/26 edition capture the signer, and items 25 to 27 and 29 capture the countersigner.

The fields that trip people up

The table covers the fields where a regulation stands behind the box, or where a wrong entry causes problems later. Field numbers are those on the 05/26 edition.

Field	What to enter	Regulation behind it	Common mistake
2 to 5, sponsor name, address, telephone	The sponsor as defined in 312.3(b)	Name, address and telephone number of the sponsor (312.23(a)(1)(i))	Naming the drug supplier when it is not filing the IND
3, date of submission	The date the submission goes to FDA	Date of the application (312.23(a)(1)(i))	A date that differs from the cover letter, which FDA’s instructions say it should match
6, name of drug	All names: trade, generic, chemical or code	Name of the investigational new drug (312.23(a)(1)(i))	Using a code name in one submission and a generic name in the next
7A, IND number	Blank for an initial IND, the assigned number afterwards		Dropping the leading zeros FDA’s instructions ask for on numbers under six digits
7B, IND type	Commercial or Research		An academic sponsor moving to a Phase 2 or 3 protocol without reading FDA’s note on when to switch to Commercial
9, phase	Phase 1, 2, 3 or other	Identification of the phase or phases (312.23(a)(1)(ii))	Ticking only the first phase when the IND covers more
10, referenced applications	Other INDs, NDAs, DMFs and BLAs referred to	A reference to another person’s submission needs that person’s signed written authorization (312.23(b))	Listing a DMF or another sponsor’s IND without the letter of authorization
11, serial number	The submission’s serial number	Serial numbering of each submission (312.23(e))	See the note below the table
12A, submission type	Every type the submission contains		Ticking “Other” when a specific box exists
14, special cases	Exception from informed consent, charge request, expanded access	Exception from informed consent must be identified prominently on the cover sheet (312.23(f))	Leaving the emergency research box unticked for a 50.24 study
16, CRO	Yes or no, with a continuation page	Name and address of the CRO, the study, and the obligations transferred (312.23(a)(1)(viii))	Ticking yes without listing the obligations
17, monitor	Name and title of the person responsible for monitoring	312.23(a)(1)(vi)	Naming a CRO instead of a person
18, safety reviewer	Name and title of the person responsible for safety review under 312.32	312.23(a)(1)(vii)	Leaving it unchanged after that person leaves

The serial number format is not aligned between the regulation and the form. 312.23(e) requires a single, three-digit serial number, with the initial IND numbered 000. Item 11 on the 05/26 edition instructs “Serial number: 0000” for the initial IND and “0001” for the next submission. We cite the regulation here. Ask your FDA project manager which format the submission system expects, and use one format throughout the IND.

One form, many submissions

Item 12A on the 05/26 edition is a list of everything an IND can receive. The regulation sets the label most of them must carry.

Submission	Regulation	What it is for	Where we go deeper
Initial IND	312.23	The application itself	The IND application
Protocol amendment: new protocol, change in protocol, new investigator	312.30	A study not yet in the IND, a significant change, or a new investigator	21 CFR 312 map
Information amendment	312.31	Essential information not within a protocol amendment, safety report or annual report
IND safety report	312.32	Potential serious risks, reported to FDA and all participating investigators	Expedited safety reporting
Annual report	312.33	Progress report within 60 days of the IND’s anniversary	DSUR guidance
Response to clinical hold	312.42(e)	A complete response asking FDA to remove a hold
Request for reactivation	312.45(d)	A protocol amendment to resume an inactive IND

Each type has a label the regulation asks for. A protocol amendment must be prominently identified as “Protocol Amendment: New Protocol”, “Protocol Amendment: Change in Protocol” or “Protocol Amendment: New Investigator” (312.30(d)). An information amendment must prominently identify its contents, for example “Information Amendment: Chemistry, Manufacturing, and Control” (312.31(b)). An IND safety report must be identified as “IND Safety Report” (312.32(c)(1)(v)), and follow-up information as “Followup IND Safety Report” (312.32(d)(2)). The boxes in 12A carry the same names, so tick the box that matches the label.

Timing differs by type. A new protocol or a change in protocol must be submitted before it is implemented, while new-investigator amendments may be grouped and submitted at 30-day intervals (312.30(e)). Information amendments should be submitted as necessary but, where feasible, not more than every 30 days (312.31(c)). If a sponsor on clinical hold submits a written request to lift it with a complete response to the issues, FDA must respond in writing within 30 calendar days (312.42(e)). That complete response goes in under a 1571 like any other submission, as our guide to FDA clinical holds explains.

Transferring obligations to a CRO on the 1571

A sponsor may transfer any or all of its Part 312 obligations to a CRO, and the transfer must be described in writing (312.52(a)). If not all obligations are transferred, the writing must describe each one the CRO assumes, and any obligation not described is deemed not to have been transferred (312.52(a)). The cover sheet must state the CRO’s name and address, identify the study, and list the obligations transferred, or give a general statement if everything was transferred (312.23(a)(1)(viii)).

Item 16 on the form is where that statement goes, on a continuation page. The list should match the contract. A CRO that assumes a sponsor obligation is subject to the same regulatory action as the sponsor for failing to meet it (312.52(b)). For how to scope and oversee that transfer, see the CRO oversight guide.

Current version, download, and the “expired form” question

The current form is on FDA’s IND Forms and Instructions page. When we checked on 29 October 2026, the PDF linked there was Form FDA 1571 (05/26), marked “PREVIOUS EDITION OBSOLETE”, with OMB No. 0910-0014 and an expiration date of 31 July 2027. FDA’s field-by-field instructions are a separate document, the Form FDA 1571 Supplement, dated 6/24.

FDA’s New and Updated FDA Forms page lists the latest changes: the orphan designation number in item 8A became a fixed “DRU-YYYY” prefix plus five digits, the SNOMED CT indication term split into items 8B and 8C, and item 12B gained a yes or no question on real-world evidence.

Two dates on the form answer the “expired” question. The edition date in the footer, (05/26) on the current form, tells you which version you have. The OMB expiration date in the top corner is the end of the form’s current Paperwork Reduction Act approval, and the form’s own PRA statement says a person is not required to respond to a collection of information unless it displays a currently valid OMB number. If either date on your saved copy is older than the one on FDA’s page, download the form again. Don’t rely on a copy saved in a submission template, and check the edition before each submission rather than once a year.

Form 1571 vs Form 1572

The 1571 is the sponsor’s form: the IND cover sheet the sponsor signs (312.23(a)(1)). The 1572 is the investigator’s: a signed investigator statement the sponsor must obtain before an investigator begins participating (312.53(c)(1)). The Form FDA 1572 guide covers the investigator’s commitments field by field.

Sources

• 21 CFR Part 312, Investigational New Drug Application, eCFR text up to date as of 14 April 2026