Form Fda 1572 Food And Drug Administration

Use a Form FDA 1572 PDF Food And Drug Administration 2013 template to make your document workflow more streamlined.

What Form FDA 1572 means

Form FDA 1572 is the Statement of Investigator used in U.S. clinical research to identify the investigator, trial site, responsible personnel, institutional review board, and laboratories. The investigator signs it to state qualifications, accept protocol responsibilities, follow informed-consent and reporting obligations, and permit FDA inspection of relevant records. A sponsor or coordinator can upload the form to signNow, place or detect fillable fields, route it to the investigator, and preserve the signed PDF with an audit trail. The form supports study documentation; it does not replace sponsor, IRB, or FDA requirements.

How the Form FDA 1572 workflow works

Use a controlled sequence to prepare, sign, and preserve the investigator statement without changing its clinical-trial content.

Upload form: Upload the current investigator statement
Prepare fields: Detect or place required fields
Send packet: Route the form to the investigator
Archive evidence: Store the signed record and audit trail

Signer authentication:

Verify identity and signing access

Timestamp capture:

Record the signing event time

Document hashing:

Link the signed file to its digest

Tamper-evident sealing:

Protect the completed record from unnoticed changes

Audit history:

Preserve signer actions and document history

Trail export:

Retrieve or export evidence for study review

Setting	Recommendation
Authentication method	SAML SSO with SCIM provisioning
Signature type	Electronic signature with signer intent
Audit trail	Capture timestamps, IP addresses, and signer actions
Document retention	Retain records under 21 CFR 312.62(c)
Encryption	AES-256 at rest and TLS 1.2 or 1.3 in transit

Signer authentication for Form FDA 1572

PKI:

PKI-based signer authentication

X.509 certificates:

Certificate-based document identity

Two-factor authentication:

Additional account verification

SMS OTP:

One-time passcodes by text

ID verification:

Identity checks for signers

Audit evidence:

Recorded investigator signing event

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Platform requirements for Form FDA 1572

Form FDA 1572 can be prepared and signed through a browser on Windows or macOS using Chrome, Firefox, Safari, or Edge. Signers can review the investigator statement on iOS and Android devices through signNow mobile apps, subject to organizational controls and internet access.

Browsers Chrome, Firefox, Safari, and Edge
Operating systems Windows, macOS, iOS, and Android
Devices Desktop and mobile signing

Clinical-trial teams should use managed devices, controlled account permissions, and an approved storage policy for signed Form FDA 1572 records. Enterprise deployments may connect signNow through API access or SSO, while regulated teams should confirm their certificate, audit-trail, and retention configuration against the sponsor’s procedures and FDA recordkeeping obligations.

Recordkeeping practices for Form FDA 1572

Accurate fields, investigator attribution, controlled access, and documented retention keep Form FDA 1572 usable during sponsor, IRB, and FDA review.

Validate every investigator and site field

Confirm the current Form FDA 1572 version, investigator name, site information, responsible personnel, IRB, and laboratory details before sending. Compare the completed statement with the sponsor’s study file, because signNow preserves the workflow record but does not determine whether clinical-trial information is accurate.

Route the certification to the investigator

Assign the signature request to the investigator named on Form FDA 1572, not to a coordinator completing administrative preparation. Use signNow role assignments and signer authentication to document who signed, then review the audit trail before filing the completed statement.

Apply the investigator record retention rule

Retain the signed Form FDA 1572 and completion evidence according to the study record plan. For investigator records, 21 CFR 312.62(c) requires retention until two years after a marketing application is approved for the indication, or two years after investigation discontinuation and FDA notification if no application is filed.

Archive the signed statement securely

Export or otherwise preserve the signed PDF and audit trail in the sponsor’s controlled repository. Restrict access to authorized study personnel, maintain a reproducible copy, and document any replacement or correction process instead of overwriting the original signed record.

Find and fill out the correct form fda 1572 pdf food and drug administration

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)

Risks of mishandling Form FDA 1572

Incomplete certification

Missing signature

Attribution dispute

Unverified investigator identity

Integrity challenge

Altered study record

Recordkeeping gap

Unrecoverable audit evidence

Who works with Form FDA 1572

Clinical investigators use Form FDA 1572 to identify their qualifications, trial site, responsible personnel, IRB, and laboratories while documenting required commitments. signNow can route the prepared investigator statement for signature and preserve the completed record with its audit trail for sponsor-controlled study files.
Clinical research coordinators prepare investigator packets, verify required fields, and send them for the investigator’s signature. With signNow templates, role-based access, and audit trails, coordinators can organize repeated site workflows without signing on the investigator’s behalf.

Integrations for investigator records

Connect clinical-trial document workflows with named CRM, ERP, cloud storage, and project systems to route Form FDA 1572 records consistently.

Features	signNow	DocuSign	Adobe Sign	PandaDoc	Dropbox Sign
Starting price	$8/user/month annually	Not verified	Not verified	Not verified	Not verified
Free trial	7 days, no card	Not verified	Not verified	Not verified	Not verified
Bulk send	Business Premium included	Not verified	Not verified	Not verified	Not verified
Audit trails	Included on Business	Not verified	Not verified	Not verified	Not verified

Privacy and disclosure pitfalls

Uploading an outdated Form FDA 1572 can leave investigator qualifications, facility details, or protocol information inconsistent with the current clinical-trial file.
Sending the form to the wrong signer can weaken attribution because the investigator, rather than delegated study staff, must provide the required certification.
Exposing investigator addresses, telephone numbers, or professional credentials through uncontrolled sharing can create unnecessary privacy and access-management risk.
Failing to preserve the signed form and completion history can make later sponsor, IRB, or FDA record review harder to document.

Form FDA 1572 troubleshooting questions

Resolve signing, attribution, retention, and compliance questions before placing a completed Form FDA 1572 in the clinical-trial record.

Confirm that the uploaded file is the intended Form FDA 1572 version and that investigator, facility, IRB, laboratory, and protocol fields remain readable. signNow Business provides templates and audit trails, but clinical-trial teams must validate content against sponsor and FDA requirements before sending.

The investigator should be assigned the signature field because Form FDA 1572 contains the investigator’s certification and commitments. signNow lets the sender specify signer roles and capture the signing event; delegated staff should not substitute their own signature for the investigator’s.

Use signNow’s audit trail to review the signer identity, timestamps, IP address, and document actions. Under ESIGN and UETA, electronic records can support enforceability when intent, consent, attribution, and reliable retention are established; FDA-specific procedures may require additional controls.

Business includes audit trails, templates, and mobile apps at $8 per user per month with annual billing. Business Premium costs $15 per user per month annually and adds bulk send, which can help distribute repeated investigator packets.

signNow is HIPAA compliant when a business associate agreement is required, and its compliance materials include SOC 2 Type II and ISO 27001. FDA-regulated organizations should separately verify whether their workflow needs 21 CFR Part 11 controls and configure them appropriately.

If a signer cannot open the invitation, resend it or provide a controlled signing link after confirming the email address. The signer may use a supported browser or mobile app; the sender should retain the completed Form FDA 1572 and its audit trail with the study records.

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Form Fda 1572 Food And Drug Administration

What Form FDA 1572 means

How the Form FDA 1572 workflow works