Participants sign and verify by email OTP. Investigators countersign with their password. Every signature is hashed to the exact document it was applied to.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
2
required signatures: participant, then investigator
1
email OTP step before a signature is accepted
2
optional signers: witness and LAR
Hashed
to the exact document content at signing
How it works
They read the consent document on their own device and draw their signature.
A one-time passcode is sent to their email and must be confirmed before the signature is accepted.
The participant confirms they understand the signature is legally binding before it is captured.
Authorized site staff review the document and countersign with password re-authentication. The document is now Fully Executed.
Why it holds up
A signature that stands in for wet ink needs to prove three things: who signed, that they meant to, and that the record has not changed since. Capture’s flow addresses all three, rather than just capturing an image.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Who can sign
Signs on their own device after reading the consent document.
Countersigns with password re-authentication after reviewing the signed document.
Optional co-signature for impartial third-party verification, when required.
Can sign on behalf of a participant who cannot consent themselves, with the relationship recorded.
Build a free sandbox study and go through the participant and countersignature flow end to end.
The difference
The participant draws their signature on screen, then confirms it through a one-time passcode sent to their email, after acknowledging that the signature is legally binding.
After the participant signs, an investigator or authorized site staff member reviews the document and signs it again, re-authenticating with their password. The document is only Fully Executed once both signatures are recorded.
Yes. If the participant cannot consent themselves, a Legally Authorized Representative can sign on their behalf, and that relationship is recorded with the signature.
Each signature records a hash of the exact document content at the moment of signing. If the document changes afterward, the hash no longer matches, so alteration is detectable.
No. Witness co-signature is optional and configured per study, for cases that specifically require impartial third-party verification.
For most consent and countersignature workflows, yes, provided your IRB or ethics committee accepts electronic consent. Confirm any board-specific requirements for a given study.
Keep exploring
21 CFR Part 11 compliance checklist
The regulation this signature workflow is built for.
Audit trail software
Where every signature event is logged.
eConsent software
The full consent-building and signing workflow.
Digital informed consent software
Replacing paper consent with a digital process.
ALCOA+ data integrity checklist
How a verified signature supports Attributable and Original.
Econsent without paper forms
Moving a whole consent process off paper.
Free sandbox with every feature. No credit card, no sales call.