Fda 1572
Use a Fda 1572 2019 template to make your document workflow more streamlined.
What Form FDA 1572 does
Form FDA 1572 is the Investigator’s Statement for an FDA-regulated clinical investigation of an investigational drug or biologic. The clinical investigator identifies the study, sponsor, research site, qualifications, responsible personnel, reviewing institutional review board, and required commitments. The investigator signs the statement to confirm that the information is accurate and that the study will follow the protocol, investigational-product controls, informed-consent requirements, and applicable FDA regulations. signNow can help prepare a completed form, route it to the required signer, and retain the executed PDF and audit trail.
Who completes Form FDA 1572
Clinical investigators use Form FDA 1572 to identify their qualifications, trial responsibilities, and study-site details before participating in an FDA-regulated investigational drug or biologic study. signNow can route the completed statement for signatures and preserve the executed record with its audit trail. Clinical research coordinators prepare investigator packets for principal investigators and subinvestigators, checking that study title, protocol number, facility information, and delegated responsibilities match sponsor records before sending Form FDA 1572 through a controlled signature workflow.
Organizations that use Form FDA 1572
Form FDA 1572 belongs in clinical-trial workflows where investigators, sponsors, research sites, and coordinators must document study responsibilities.
Independent clinical investigators use Form FDA 1572 to document personal qualifications, research-site details, delegated study responsibilities, and commitments before signing an investigational drug or biologic study statement. Academic medical centers and research hospitals use controlled templates to collect investigator statements across departments, while coordinators verify protocol, site, and reviewing IRB information before routing each signature. Contract research organizations and pharmaceutical sponsors coordinate investigator packets across multiple sites, using audit trails and repositories to monitor completed statements without treating signNow as the FDA filing authority.
These tasks are executed by both individual contributors and centralized administrators depending on organizational policy and required controls.
How signNow handles Form FDA 1572
The workflow moves the investigator statement from controlled preparation through signature and study-record archival.
Upload and inspect: Upload the sponsor-approved Form FDA 1572 and review detected fields. Assign the investigator: Add the investigator as signer and configure authentication. Route for signature: Send the statement for review and electronic signature. Archive the record: Store the signed PDF with its audit trail.
Ways to send and sign Form FDA 1572
- Use the signNow web app to upload Form FDA 1572, place or confirm fields, and prepare a controlled request for the investigator’s signature.
- Use the signNow mobile app when coordinators or investigators need to review study-site information and complete the statement from an iOS or Android device.
- Use kiosk mode for supervised, on-site completion only when the study organization controls the device and confirms the investigator’s identity.
- Create a shareable signing link when the sponsor’s procedure permits link-based access, then preserve the completed form and audit trail in controlled records.
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Recommended Form FDA 1572 workflow setup
Configure the workflow around investigator identity, study-record integrity, auditability, and the retention rule applicable to the clinical investigation.
| Setting | Recommendation |
|---|---|
| Authentication method | Email verification with SMS OTP |
| Signature type | Electronic signature with signer intent |
| Audit trail | Detailed completion certificate and activity log |
| Document retention | Two years after investigation ends under 21 CFR 312.62(c) |
| Encryption | TLS 1.2/1.3 in transit and AES-256 at rest |
What the Form FDA 1572 audit trail records
The audit trail documents the signature transaction separately from the clinical judgment that the investigator and sponsor apply to the form’s content.
Authenticate signer:
Capture timestamp:
Record document hash:
Seal transaction:
Review completion:
Retrieve audit trail:
Best practices for Form FDA 1572
Accurate study information, controlled versions, verified signing, and documented retention reduce avoidable clinical-trial record problems.
Reconcile every study field before signing
Control versions and superseded statements
Authenticate the responsible clinical investigator
Archive the form with its audit trail
Find and fill out the correct expiration date march 31 2022
airSlate SignNow helps you fill in and sign documents in minutes, error-free. Choose the correct version of the editable PDF form from the list and get started filling it out.
| Versions | Form popularity | Fillable & printable |
|---|---|---|
| FDA 1572 *2019 2019 | 4.8 Satisfied (1323 Votes) | |
| FDA 1572 *2019 2013 | 4.7 Satisfied (336 Votes) |
Key signNow features for Form FDA 1572
Form FDA 1572 workflows benefit from controlled templates, signer authentication, audit evidence, and organized storage for investigator and sponsor records.
Controlled upload
Upload the sponsor-approved Form FDA 1572 and confirm its study-specific fields before placing or reviewing signature fields.
Signer routing
Route the investigator statement to the named signer using email verification or stronger authentication configured for the study workflow.
Audit trail
Preserve the completed statement with a certificate of completion and detailed activity history for later study-record review.
Reusable templates
Use reusable templates for recurring investigator statements while keeping each study, protocol, site, and signer assignment distinct.
Mobile access
Allow investigators and coordinators to review or sign from supported desktop and mobile workflows when study procedures permit.
Record integrations
Connect completed records with repositories such as Box, Egnyte, Google Drive, or AWS according to the organization’s records policy.
Security controls for Form FDA 1572
Transport encryption:
Stored-document encryption:
Security certification:
Information security:
Regulated records:
Protected health information:
Form FDA 1572 use cases in clinical research
Clinical-trial teams can adapt electronic signature workflows to investigator statements while preserving study-specific review and records controls.
Healthcare research
Fertility Centers of Illinois describes using airSlate SignNow with an API and responsive support for its healthcare organization. A comparable clinical-research workflow can route investigator statements and preserve completed records.
- Healthcare study administration
- API-connected document routing
The customer story supports the operational value of connecting electronic signature workflows with healthcare systems, but it does not state that the organization used Form FDA 1572 specifically. For a trial, the sponsor should map the form, signer, study, and repository requirements separately.
Multisite clinical trials
A clinical research organization managing multicenter studies may prepare one Form FDA 1572 packet per investigator and site, then send each statement through a controlled sequence.
- Site-specific investigator statements
- Centralized completion tracking
signNow can provide reusable templates, signer routing, completion certificates, and audit-trail records for this administrative process. The sponsor remains responsible for determining whether each statement is complete, current, appropriately signed, and retained under the study’s governing procedures.
Common Form FDA 1572 problems
The protocol number, study title, or sponsor information differs between Form FDA 1572 and the current clinical-trial documentation. A site address, reviewing IRB, subinvestigator, or delegated responsibility changes after the investigator signs the statement. Teams retain the signed PDF but omit the completion certificate or audit trail needed to explain the electronic signing transaction. A coordinator routes the statement to the wrong investigator or uses an outdated template for a different study site.
Processing stages for Form FDA 1572
Processing time depends on study review and investigator availability; signNow organizes the document sequence without creating an FDA filing deadline.
Prepare the statement
Deliver to the investigator
Complete investigator review
Archive the completion
How long to retain Form FDA 1572 records
Retention depends on the record owner and study status; apply the cited FDA rules and any longer sponsor or institutional policy.
Two years after study end
Three years after study completion
Two years after application action
Two years after study end
Two years after investigation end
Form FDA 1572 troubleshooting questions
These answers address field preparation, electronic-signature evidence, plan capabilities, privacy controls, and the boundary between signing and FDA study administration.
Upload the sponsor-approved Form FDA 1572 as a PDF, then inspect every detected field before sending. Auto-detection can accelerate preparation, but the coordinator must confirm that study, site, investigator, and signature fields are mapped correctly. The Business plan includes templates and audit trails.
A completed electronic Form FDA 1572 can support an auditable signing record when intent, consent, signer attribution, and record retention requirements are satisfied. ESIGN and applicable state law govern electronic-signature enforceability; FDA study-record obligations still apply separately under 21 CFR Part 11 and related regulations.
Use signNow’s audit trail and completion certificate to preserve delivery, signer activity, timestamps, and the final document. For regulated clinical records, confirm the organization’s validation, access-control, and retention procedures; a platform feature does not replace sponsor or institutional responsibility.
Business includes legally binding eSignatures, audit trails, templates, and mobile apps. Business Premium adds bulk send, kiosk mode, request payments, and quick invite links. Select the plan based on the study organization’s workflow, authentication, and records requirements rather than assuming every FDA control is included automatically.
HIPAA compliance is available with a business associate agreement where protected health information is involved. Form FDA 1572 itself identifies investigators and study information, so the sponsor or institution should determine whether the transaction includes PHI and apply its privacy and access policies.
A signed Form FDA 1572 should not be treated as a substitute for sponsor submission, investigator qualification review, IRB oversight, or FDA inspection requirements. Export the executed document and audit trail, then place them in the sponsor’s or institution’s controlled study-record repository.
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