Form 1572
Use the Form 1572 2016 template to simplify high-volume document management.
What Form 1572 covers
Form 1572 is the FDA Statement of Investigator used by a clinical investigator to document commitments for conducting an investigational study. It identifies the investigator and research site, records applicable qualifications and study responsibilities, and confirms obligations involving the protocol, informed consent, institutional review board oversight, safety reporting, and study records. The investigator reviews the completed statement, signs it, and provides it through the sponsor’s submission process. signNow can route the prepared PDF for an electronic signature, capture the signing event, and retain the completed document with its audit trail.
Who uses Form 1572 and why
Clinical investigators
Clinical investigators use Form 1572 to document their study commitments, site information, qualifications, and responsibilities before participating in an FDA-regulated investigational study. Sponsors and clinical research organizations coordinate review, signature routing, and controlled storage of the completed statement.
Study sponsors
Sponsors and research organizations prepare Form 1572 templates, verify investigator and site details, route signatures, and retain the completed statement with its certificate and audit trail. Coordinators may support preparation, but the investigator remains responsible for reviewing and signing the statement.
How Form 1572 signing works
The signNow workflow connects the sponsor-approved Form 1572 source file with investigator review, signature, and controlled recordkeeping.
Upload: Upload the sponsor-approved Form 1572 PDF Review: Review detected fields and study details Route: Route the statement to the investigator Complete: Capture signature and audit evidence
How to complete Form 1572 online
Prepare the current Form 1572 carefully, then use signNow to route the investigator’s signature and preserve the completed record.
Upload:
Upload the current PDF Prepare:
Review detected fields and add missing signature or date fields Assign:
Assign the investigator as signer Send:
Send through the sponsor-approved workflow Archive:
Store the completed PDF and audit trail
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Key features for Form 1572 workflows
signNow connects Form 1572 preparation, investigator routing, electronic signing, audit evidence, and controlled record storage in one workflow.
Field preparation
Upload the current Form 1572 PDF and review signNow’s detected fields before adding or correcting signature, date, and required-entry fields. This reduces manual placement errors while keeping the sponsor’s source document intact.
Signer routing
Assign the investigator as the signer and send the document through a controlled email workflow or signing link. The routing record connects the completed statement to the intended investigator and study process.
Audit trail
Capture the signing event with timestamps, signer activity, and a certificate of completion. The audit trail gives study teams an organized record supporting review of how Form 1572 was executed.
Reusable template
Use templates for recurring investigator submissions while checking study-specific details before each send. Templates can standardize field placement without replacing sponsor review of investigator, site, and protocol information.
Mobile signing
Review and sign Form 1572 from a desktop or mobile device. Mobile access is useful for investigators working away from the site office, provided the sponsor’s security and access requirements are followed.
Controlled storage
Store the completed PDF and audit trail in the designated study repository. signNow’s security controls include encryption in transit and at rest, while the sponsor remains responsible for retention and access policy.
Signer authentication for Form 1572
PKI signatures:
X.509 certificates:
Two-factor authentication:
SMS OTP:
ID verification:
Signing evidence:
Find and fill out the correct form 1572 2016 2019
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 2016 | 4.8 Satisfied (8185 Votes) |
Platform requirements for Form 1572
Form 1572 can be prepared through a supported browser using Windows, macOS, iOS, or Android. signNow encrypts data in transit with TLS 1.2 or TLS 1.3, and its mobile apps support document review and signing.
Browsers Chrome, Firefox, Edge, and Safari Operating systems Windows, macOS, iOS, and Android Secure connection TLS 1.2 or TLS 1.3 connection
Organizations handling investigator records should use managed devices, current browser versions, and controlled access. Enterprise deployments can connect signNow through API integrations and SSO provisioning; configure retention, signer authentication, and certificate requirements according to the study sponsor’s procedures and applicable FDA recordkeeping obligations.
What the Form 1572 audit trail records
The audit trail documents how the investigator accessed, reviewed, signed, and completed Form 1572 without replacing sponsor quality-control review.
Authenticate signer:
Capture timestamp:
Record activity:
Seal record:
Create certificate:
Retrieve audit trail:
Recordkeeping practices for Form 1572
Use a controlled workflow that preserves the completed Form 1572, its audit trail, and the study-specific retention decision.
Preserve the complete signed record
Export the audit trail
Restrict study-file access
Verify fields before signature
Privacy and disclosure pitfalls
Including investigator credentials or site information in the wrong version of Form 1572 can expose sensitive study details and require controlled correction before signature. Sending the statement without confirming electronic-consent procedures can weaken evidence that the investigator understood and intended to sign the electronic record. Granting broad workspace access can expose signed Form 1572 records to personnel outside the sponsor, site, or quality-assurance roles that require access. Storing the completed PDF without its audit trail can make it harder to demonstrate signer attribution, timestamps, and the sequence of document actions.
Documents outside Form 1572
Notarization
Wills
Family law
Real-estate deeds
Form 1572 troubleshooting questions
Resolve Form 1572 workflow issues by checking the source PDF, signer assignment, authentication, audit evidence, and sponsor retention controls.
Upload the current Form 1572 PDF and inspect signNow’s detected fields before sending. If a required field is missing, add it manually and compare the final document with the sponsor-approved source. Do not assume automatic detection identified every study-specific entry or signature location.
Assign the investigator’s email address as the signer and confirm the recipient before sending. signNow can use email delivery, signing links, or stronger authentication options. The sponsor should select the method required by its study procedures and document any identity-verification decision.
signNow’s Business plan includes legally binding eSignatures, templates, audit trails, and mobile apps at $8 per user per month when billed annually. Confirm the selected plan’s capabilities before routing Form 1572, especially if bulk sending or advanced authentication is required.
Electronic signing generally receives legal recognition under ESIGN, 15 U.S.C. ch. 96, and applicable UETA law when intent, consent, attribution, and record reproducibility are established. The sponsor must also confirm that its protocol, institution, and submission process permit electronic execution.
Export the completed Form 1572 together with its certificate of completion and audit trail. Keep the files in the sponsor-approved study repository, apply role-based access, and follow the applicable FDA recordkeeping policy rather than relying only on the platform copy.
signNow supports encryption in transit with TLS 1.2 or TLS 1.3 and encryption at rest with AES-256. If the workflow contains protected health information, HIPAA compliance requires a business associate agreement and appropriate sponsor controls.
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