When a participant consents from home, how do you know who signed? This page lays out the verification options, what regulators ask for, and what Capture does (email one-time code, two-step signature, staff countersignature) and does not do (no ID document scan, no selfie or video check, no KYC).
Free sandbox · No credit card · 21 CFR Part 11 aligned
Participant reads the consent on their phone
Version shown is fixed
Acknowledges the legal-binding statement
Enters the one-time code sent to their email
Step 1 of the two-step check
Signs on screen
Step 2
Staff countersign with password re-authentication
Then status becomes Fully Executed
What to know first
The requirement
On paper, identity is checked implicitly: the person sits in the room, the coordinator knows who is in the room and signs as witness to the process. Remote consent removes the room. The question regulators and ethics committees ask is whether the electronic process still gives equivalent confidence that the signer is who the record says. For FDA-regulated work, the electronic signature rules of 21 CFR Part 11 add that a signer's identity should be verified before an electronic signature is established, and the electronic informed consent Q&A from FDA and OHRP expects a remote process to include a way to confirm that the person signing is the participant or the legally authorized representative.
Notably, neither document names a technology. "Click I agree" without a linked identifier is generally not considered an acceptable electronic signature, but what counts as sufficient identification is left to the sponsor and the reviewing ethics committee, guided by risk. A minimal-risk survey and a first-in-human study with a vulnerable population reasonably need different levels of assurance. In the EU, ethics committees and national authorities apply their own expectations, and the eIDAS regulation defines levels of electronic signature that some countries or committees may reference; check what yours expects.
The practical conclusion is to treat identity verification as a layered control rather than a feature you buy. Some layers live in the software, others in the study procedure and others in who you recruit and how. The table below sets them out so you can choose, and document, the combination your study needs.
The options
General industry options, not a statement of what any one vendor offers. The last column says whether Capture provides it.
| Method | What it establishes | Main weakness | In Capture? |
|---|---|---|---|
| Email one-time code | The signer controls the email address used for the invitation | Does not prove who owns the mailbox | Yes: mandatory step in the two-step signature |
| SMS one-time code | The signer controls a phone number | SIM swap and shared phones; needs number on file | Not claimed |
| Staff-verified identity by call or visit | A trained person confirms the participant against what they know or have seen | Depends on procedure and documentation | As your SOP, with staff countersignature recorded |
| Government ID document scan | The ID looks genuine and matches the name given | Privacy impact; accessibility; extra vendor | No |
| Selfie or video liveness match | The face matches the ID photo | Bias, accessibility and data-protection concerns | No |
| National digital identity or qualified signature | Identity proofed by a state or trust service | Availability varies by country | No |
| In-person verification, then remote follow-up | Identity established once at the clinic | Requires a visit | Fits: consent can be reviewed remotely after an onsite check |
Check that anything you add in the identity layer is covered by the consent form, the privacy notice and ethics approval. Collecting ID images creates additional personal data to protect.
What Capture does
The Capture signing flow is designed so a signature is tied to a verified step, an acknowledged statement and the exact document the participant saw.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
What Capture does not do
Listing limits plainly lets your ethics committee and QA decide whether the remaining layers are enough. Capture does not provide the following, and this page does not imply that it does.
Layers
4
In software
3
Send a consent to your own email in the free sandbox, complete the code step, sign and countersign. Then decide which extra layers your study needs.
Designing the layers
Start with the risk questions: how serious is the study, how vulnerable are participants, how easy would impersonation be and what would it cost if the wrong person signed? A low-burden observational study using people already known to the site needs little beyond a code-verified signature and countersignature. A study that pays participants, recruits through open social channels or involves a restricted population carries a higher risk of fraudulent enrollment and justifies a staff call.
A short scheduled call between a trained coordinator and the participant is a strong control. The coordinator confirms who they are speaking to against what the site knows, answers questions and records the call in the study file. Capture records the countersignature and the audit trail; the call itself is a procedure you document, not a feature we claim.
When a representative signs, the identity question has two parts: who the representative is and their relationship to the participant. Capture supports LAR signatures; the relationship check remains a site procedure. See legally authorized representative consent and pediatric assent.
Where a witness is required, such as for participants who cannot read, Capture supports an optional witness co-signature. For more on that process, see impartial witness eConsent.
Document the identity approach in the protocol or consent procedure and in the privacy notice, get the ethics committee to approve it and file evidence of each check. A control that is not documented does not exist at inspection. Our decentralized trial consent template is a starting point for the wording; adapt it with your reviewers.
Evaluation checklist
Useful for Capture and for every alternative you are comparing, including those in [best eConsent software](/solutions/best-econsent-software).
Ask for the sequence step by step and test it yourself in a sandbox.
Look for a hash or equivalent that binds the signature to the content seen.
Check who may countersign and how their identity is confirmed.
Check that the signed PDF carries signature data, timestamps and the audit trail.
ID images and biometrics need legal basis, security and retention rules.
Confirm the process supports a pre-consent call or onsite check.
Signing is verified through a two-step process that includes mandatory email OTP confirmation, an on-screen signature and an acknowledgement of the legal-binding statement. Authorized site staff then countersign with password re-authentication.
No. Capture does not provide ID document scanning, selfie or video liveness verification or KYC. If your study needs those layers, add them through a documented site procedure or a separate tool approved by your ethics committee.
It proves control of an email address at that moment, not who owns it. Whether it is enough depends on study risk and your ethics committee and sponsor; many studies combine it with a staff call or onsite check.
The FDA and OHRP Q&A on electronic informed consent expects a remote process to include a way to confirm the signer is the participant or LAR, without prescribing a method. Check current guidance and your local ethics committee requirements.
Yes. Capture supports LAR signatures. The representative relationship check is a site procedure.
Each signature is cryptographically linked (hashed) to the exact document content at signing time, and the signed consent exports as a PDF with embedded signature data, timestamps and audit trail.
No claim is made for advanced or qualified signatures under eIDAS. If your jurisdiction requires them, confirm with your ethics committee before relying on Capture signatures alone.
Open the free sandbox, send a consent to your own email, complete the code step, sign and countersign. It has every feature, with no credit card and no time limit.
Keep exploring
Digital informed consent software
The full eConsent workflow.
Remote patient consent
Consent without a site visit.
Electronic signatures for clinical trials
How the two-step signature works.
Impartial witness eConsent
Witnessed consent.
Legally authorized representative consent
Consent by a representative.
eConsent for decentralized trials
Remote-first consent.
Free sandbox with every feature. Send yourself a consent, verify with the code, sign and countersign.