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What is Form FDA 1571 used for?
Form 1571 identifies the sponsor’s IND submission, its product, transaction, contents and relevant responsibilities. Reconcile the application identifier and serial number with actual submission history, and select the purpose of the current transaction. The drug supplier is not automatically the sponsor, and a new protocol does not automatically create a new IND.
Before you begin
Form 1571 preparation for an IND transaction. A supplier is not automatically the sponsor; research/commercial classification requires the actual development context. Individual patient expanded access has a separate 3926 route where applicable.
What you will prepare: A completed draft tied to the true application and attachment inventory, with unresolved classifications escalated before signature.
Build the identity and transaction worksheet
Obtain the sponsor’s controlled identity/contact record, product description, assigned IND record, submission history, cover letter and current attachment list. Reconcile the submission date with the cover letter and distinguish the sponsor from the entity supplying the drug. Use the assigned IND number when available; do not invent one for a new application. The instructions identify 0000 as the initial serial number, followed by consecutive serial numbers. Resolve gaps or competing publisher records before assigning the next transaction.
Resolve conditional selections by evidence
Read the instruction definitions for commercial versus research use rather than classifying solely by whether the sponsor is a company or a university. Match submission-information selections to the actual action. Check product identifiers, indication, phase, designation information and any combination-product, digital-health-technology or real-world-evidence answer against the source record. A designation belongs to its actual holder and scope. If terminology or the development purpose is unclear, request the responsible owner’s determination; do not select the nearest-looking box.
Reconcile references, obligations and attachments
Map each referenced application to the permitted information and the necessary authorization. Compare the contents selection with files actually present. Inspect the CRO agreement and identify transferred obligations accurately; a vendor contract title is not evidence that every sponsor obligation has transferred. Give the authorized signer the final form, attachment inventory and unresolved-issue record together. The real signer must review and execute the actual commitments; preparation software must not manufacture the signature or certification date.
Fictional example: a new study is not a new IND
A team adds a protocol to an existing IND but copies the “initial” serial number and original-application selection from its first submission. Compare the assigned IND and submission tracker, correct the transaction identity and select the actual purpose. If a second team has already reserved a sequence, reconcile the tracker before proceeding. The useful output is one coherent transaction record, not merely a form with every box populated.
Reconcile the transaction before reusing a prior form
Use this working record with the submission tracker and final attachment inventory.
| Control | Compare | Mismatch to resolve |
|---|---|---|
| Sponsor | Actual responsibility and controlled identity | Supplier or consultant copied into the sponsor field |
| IND identity | Assigned record and cover letter | Referenced application mistaken for the sponsor’s own IND |
| Serial number | Actual submission history | Original serial reused for a later transaction |
| Submission purpose | Content being submitted now | Original-application selection copied for an amendment |
| Conditional information | Current product and submission evidence | DHT, RWE or designation answer inferred from an older form |
| Transferred obligations | Actual agreement and scope | All obligations assumed transferred because a CRO is involved |
Current edition: the October 6 download has a 05/26 footer and includes the real-world-evidence question at 12B; the linked instructions have a 6/24 footer. Reconcile labels and applicable instructions rather than relying on the obsolete saved form.
Review exercise: one publisher reserved a serial number while another submitted correspondence. Resolve the authoritative transaction history before finalizing the next form. An internally consistent form and cover letter can still both carry the wrong serial number.
Check the cover letter and assess whether the transaction also needs Form 3674. A new protocol and another IND amendment may have different certification treatment even though both are subsequent submissions.
Your preparation checklist
0/3 checkedUse this to track your review in this visit. Checks are not saved and do not establish regulatory compliance.
Frequently asked questions
Is a company supplying the study drug necessarily the IND sponsor?
No. The 1571 instructions distinguish drug supply from responsibility for initiating the investigation and submitting the IND. Identify the actual sponsor and its controlled records rather than copying the manufacturer’s name because it appears on the product documentation.
Should the initial serial number be reused when adding a new protocol?
No. The instructions identify 0000 for the initial IND and consecutive numbering for later submissions. Reconcile the actual IND history and current transaction before assigning the serial. A new study under an existing IND is not automatically a new original application.
Does using a CRO mean all sponsor obligations have transferred?
No assumption should be made from the vendor relationship alone. Review the actual transferred obligations and report them accurately on the form. Keep sponsor identity, authorized representation and the scope of transferred responsibilities distinct when preparing the signer’s review copy.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Form instructions
Form FDA 1571: Investigational New Drug Application ↗Form footer 05/26; printed OMB expiry July 31, 2027. Actual fields, including RWE at 12B, and footer inspected October 6, 2026.
Form instructions
FDA: Instructions for Form 1571 ↗6/24 instructions, seven pages, inspected October 6, 2026. Some internal field cross-references differ; reconcile by field label with the actual 05/26 form.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 1.1. A heading identifies placement, not mandatory applicability.