HIPAA Compliant · Audit-Ready · Live

Your patients signed.
Can you prove they understood?

ConsentCollect enforces comprehension, sequences multi-party signing, and produces forensic audit evidence — so when consent is challenged, you have answers.

HIPAA Compliant
FHIR R4
21 CFR Part 11
ESIGN Act

No credit card required · Clinical and research plans available

Clinical Activity Audit Log
21 CFR Part 11
Sealed
Subject: Sarah Miller (ID: SUBJ-8801)
Protocol: Cholecystectomy Consent
Form Dispatched09:14 AM
SystemConsent form sent via secure link
Identity Verified09:15 AM
Sarah M.SMS 2FA OTP verification complete
Education Complete09:24 AM
Sarah M.Surgical Risks video watched 100%
Comprehension Verified09:24 AM
Sarah M.Teach-Back Assessment: 4/4 correct
Patient Signed09:25 AM
Sarah M.Biometric signature seal applied
Investigator Signed09:25 AM
Dr. A. Chen, MDProtocol co-signature committed
Audit Trail Sealed09:25 AM
System CoreSHA-256: d4e2f9a1...9f01 · Immutable
Consent Chain Sealed · Forensic Hash Validated · Integrity Verified
Every event cryptographically hashed and timestamped at the moment it occurs.
Built for compliance withHIPAAHL7 FHIR R4ESIGN ActeIDASUETA21 CFR Part 11
§ 01 — WHERE CONSENT FAILS

Signed doesn't mean consented.

In litigation, discovery, or an IRB audit — "they signed it" is where your defense ends, not begins. What happened before that signature is the question.

Comprehension Failure

They signed at 11 PM after pre-op sedation. No one verified they understood.

40% of surgical patients cannot accurately describe the risks they consented to. That's not a patient problem — it's a documentation failure with your name on it.

Sequence Violation

Your investigator co-signed before the subject did.

IRB protocols mandate strict signing order. One inversion — investigator before patient, guardian before subject — breaks the chain of custody. Paper has no enforcement mechanism.

Revenue Loss

8:47 AM. OR assembled. Consent form missing. Case postponed.

Up to 10% of scheduled procedures are delayed or canceled on the morning of surgery due to incomplete consent paperwork. Every one is preventable.

Zero Visibility

847 participants. 94 haven't signed. You found out at the site visit.

Research coordinators operate in the dark. No live dashboard, no expiry alerts, no automated follow-up — just spreadsheets and phone calls that come too late.

Weak Audit Trail

Their lawyer asks: can you prove she understood the stroke risk?

A PDF with a signature proves one thing: that a signature exists. Courtrooms ask different questions — what did she watch, how long did she read, what did she get right on the quiz?

Identity Gap

Anyone with the link could have signed. You have no record of who actually did.

Standard e-signatures carry no identity layer. Without OTP verification, biometric attestation, and IP logging, the named patient's signature is legally indistinguishable from anyone else's.

§ 02 — HOW IT WORKS

A consent workflow built for how healthcare actually works.

Whether you're running a surgical practice or a multi-site clinical trial, the workflow fits.

01

Build

Template library or digitize your paper form — PDF or photograph.

02

Send

Dispatch to every signatory with individual secure access links.

03

Verify

Each signer proves identity before the document opens.

04

Review

Enforced video and document review. Logged to the millisecond.

05

Comprehend

Teach-Back quiz must pass before the signature field unlocks.

06

Sealed

Biometric signature, forensic hash, FHIR R4 export. Instantly.

The signature field doesn't unlock until the patient passes comprehension verification. Not because regulations require it — because that's what informed consent actually means.

§ PRODUCT SHOWCASE

Consent Form Builder

Create compliance-ready forms quickly with access to clinical audit logs, custom formatting tools, and drag-and-drop sequencing. Collaborate efficiently by sending drafts for peer review and comments, then finalize your templates in one click.

Drag & Drop Functionality
Customization Tools
Access to Clinical Audit
Clean & Fast Development
Review & Comments Workflow
Finalize the Form
ConsentCollect Clinical Audit Dashboard & Builder
§ 03 — WHAT IT SOLVES

Nine gaps in your current consent process. All closed.

Comprehension

Patients who can prove they understood — before they sign.

Teach-Back quiz and enforced video review with millisecond-level engagement tracking. The signature field stays locked until comprehension is verified.

Chain of Custody

A signing sequence no party can break or reverse.

Subject → guardian → interpreter → witness → investigator. Each link depends on the last. Sequence violations are structurally impossible, not just discouraged.

Digitization

Legacy paper forms, digitized without touching patient data.

Drop a PDF or photograph a handwritten form. PHI Shield keeps patient identifiers out of the AI pipeline entirely. The output is a structured, audit-ready digital consent.

Research Scale

One link enrolls an entire trial cohort — without coordinator overhead.

CSV manifest upload with Double-Lock identity verification. Participants self-enroll. Investigators track status in real time. Coordinators stop chasing signatures.

Audit Trail

Evidence that holds up in discovery, not just internal review.

Every event — IP address, device, geolocation, timestamp, biometric seal — is cryptographically hashed at the moment it occurs. The record cannot be altered retroactively.

Deadline Management

No procedure canceled for a form that sat in someone's inbox.

Automated SMS and email reminders. Expiry alerts that fire before deadlines, not after. Deadline extension and re-invitation in one click.

EHR Integration

Consent data that actually lives in your EHR.

Every completed consent exports as a validated FHIR R4 resource — importable directly into Epic, Cerner, or any compliant system. No copy-paste, no data silos.

IRB Workflow

IRB revision cycles resolved in minutes, not revision rounds.

Clara AI reads IRB comments and proposes targeted corrections. Apply them directly to your ICF. Version history is automatic. Every revision is audit-logged.

Geofencing

Restricted signing boundaries and verified site location.

Ensure trial protocol compliance by enforcing or flagging signatures completed outside authorized clinical boundaries, backed by tamper-resistant location telemetry.

Clinical Auditor & Liability Shield

An invalid consent form is a
$425,000 malpractice trap.

Consent forms are routinely thrown out in court because they are written at a college grade level, omit critical alternative treatments, or lack chronological proof. Paper forms and standard e-signatures leave you defenseless in front of a jury.

$425k+
Average national settlement payout for medical malpractice claims.
$580k
Annual loss per hospital from misplaced or delayed paper consent forms.
66%
Of surgical procedures missing consent forms on the morning of surgery.
$62/min
Cost of operating room delays, piling up administrative waste.
CLARA CLINICAL AUDITOR
2 ISSUES DETECTED
ACTIVE DOCUMENT DRAFT
Cholecystectomy_Informed_Consent_v4.pdf
Critical Readability DeficitBLOCKER

Form scored 12.4 on Flesch-Kincaid (University-level reading). Malpractice courts throw out documents exceeding grade level 8.0.

Missing Alternate Treatments DisclosureWARNING

No reference to non-surgical biliary management discovered. Omission of medical alternatives triggers 78% of disclosure lawsuits.

🛡️ Bypass Protection Enabled: If you publish this form without auditing, ConsentCollect locks a permanent, non-repudiable AUDIT_BYPASSED affidavit to your digital record.
§ 04 — FOR RESEARCH TEAMS

Run a 500-participant trial. Enroll them all from one link.

Research consent has different anatomy — multiple parties, sequential authority, regulatory traceability, and enrollment at a scale that individual form management can't touch.

Complex consent chains, fully supported.

Subject, LAR, guardian, minor assent, interpreter, witness, investigator. Each role has a defined position in the signing sequence. The system enforces it.

Participants must be on-site to sign.

GPS geofencing locks the signing link to a defined radius around the trial site. Remote signing from outside the boundary is blocked and logged.

Biospecimen and sub-study opt-ins built in.

Modular consent blocks for genetics, biobanking, and secondary research. Participants opt into exactly what they choose. Each decision is recorded separately.

NCT numbers bound at the ICF level.

Trial registry numbers are embedded in the form metadata. No manual typing, no coordinator errors, no ICF that references the wrong study.

Double-Lock Identity Verification
OTP (Lock 1) + personal access code from study letter (Lock 2). Both required before enrollment proceeds.
Real-Time Enrollment Dashboard
Live status for every participant: pending, awaiting investigator, fully signed. Action alerts fire before deadlines are missed.
Lazy Enrollment — One Link, Many Participants
The master link is published once. Each participant self-identifies against the manifest and receives a unique consent instance.
Full Forensic Chain Per Participant
Every enrollment clone carries its own cryptographic snapshot hash, audit trail, and FHIR export. Each participant's record is independent.
§ 05 — COMPLIANCE ARCHITECTURE

Compliance isn't a feature. It's the foundation.

Built zero-trust, privacy-first, from the architecture up — not retrofitted onto a generic document tool.

  • AES-256 encryption for all PHI at rest and in transit
  • Cryptographic document snapshot hash generated at send-time — tamper detection built in
  • IP address, device fingerprint, and GPS coordinates logged per signature event
  • Biometric attestation (FaceID, Fingerprint, PIN) required at final signing step
  • Immutable audit logs structured for litigation discovery and IRB submissions
  • Role-based access controls with full session audit for every staff action
HIPAA
Fully HIPAA Compliant PHI handling and data governance
ESIGN
Electronic Signatures in Global and National Commerce Act
FHIR R4
HL7 Fast Healthcare Interoperability Resources — validated export
eIDAS
EU Electronic Identification and Trust Services
UETA
Uniform Electronic Transactions Act
21 CFR 11
FDA Electronic Records and Signatures regulations
§ 06 — PRICING

Per active patient. Not per envelope.

You pay for the patients you actively manage. Your entire workflow, not your click count.

Free Sandbox
$0/forever

Try all features risk-free with 1 active form and a cap of 5 signers/participants total. No credit card required.

Start Free
Clinical Practice
$49/mo

Solo practitioners through multi-physician clinics. Staff seat–based tiers from $49 to $399/mo.

View Clinical Plans
Research & Clinical Trials
$149/mo

Independent PIs through large CRO networks. Per-study pricing with unlimited participants and signatories.

View Research Plans

Large clinic networks, hospital systems, and multi-site CROs —contact Hospital Relations →

Paid upgrades have no free trials. Refunds are strictly limited to a 3-day window for unused accounts. Read our Refund Policy.

§ 07 — QUESTIONS

The questions your legal team will ask.

Clinical & Research Plans

Stop hoping a PDF holds up.
Start knowing it will.

Every procedure you run without forensic-grade consent documentation is a liability that hasn't surfaced yet.

No credit card required · Clinical and research plans · Enterprise contact available