Electronic consent has to show who signed, what exactly they signed, when, and that the investigator confirmed it. The right tool depends on your study, but the evidence it must produce does not. Here are the types of tools, the criteria that separate them, and where Capture fits.
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| General e-signature | Enterprise suite | Unified EDC + eConsent | |
|---|---|---|---|
| Built for informed consent workflows | |||
| Investigator countersignature | |||
| Consent in the same audit trail as study data | |||
| Self-serve setup | |||
| Typical study size | Any | Large | Small to large |
The short version
Criteria
| Criterion | Why it matters | Capture |
|---|---|---|
| Identity verification | Shows the signer is the participant | Email one-time code before signing |
| Signature meaning | Participants must understand they are signing | Acknowledgement of the legally binding statement before signing |
| Investigator countersignature | Consent is complete only when confirmed | Password re-authentication with a meaning statement; "Fully Executed" after countersignature |
| Witness and representative | Participants who cannot read or consent themselves | Optional witness and legally authorised representative signatures |
| Document integrity | Proves what exactly was signed | Each signature cryptographically linked to the document content at signing |
| Evidence export | For monitors, auditors and inspectors | Signed PDF with embedded signature data, timestamps and audit trail |
| Link to study data | Avoids reconciling consent and EDC | eConsent, EDC and ePRO in one study |
Where each fits
A general e-signature tool can work for low-risk studies where consent is simple and the ethics committee accepts it, but you will manage versions, countersignatures and the link to study records yourself. For regulated trials, the question is whether the tool produces the evidence a monitor or inspector expects without manual assembly.
Large global programmes with complex content, many countries and a preference for a fully managed service often choose an enterprise suite. Small and mid-sized sponsors, academic groups and CROs usually get more from a unified platform, where consent sits next to the participant's data and the same team builds both. Read how to write an eConsent form before you build, whichever you choose.
In the US, FDA and OHRP have published guidance on electronic informed consent, and FDA-regulated studies need electronic signatures that meet 21 CFR Part 11 expectations. In Europe and elsewhere, acceptance of electronic and remote consent depends on national rules and ethics committees, so check each country in your study. See electronic signatures for clinical trials.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Capture eConsent
Participants sign on screen after confirming a one-time email code and acknowledging that the signature is legally binding. The investigator countersigns with password re-authentication, and the document is fully executed only then. Witness and legally authorised representative signatures are supported, and the signed PDF exports with the audit trail.
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As a participant would.
Check re-authentication and the final status.
For participants who need one.
Signed PDF, timestamps and audit trail.
Language, remote consent and ethics acceptance.
Questions to ask
Ask how the system verifies identity for remote consent, what the signer sees before signing, and how the investigator's confirmation is recorded. Ask what happens when the consent document is revised: how new versions are approved, how participants are asked to sign the new version, and how the system shows which version each person signed.
Ask about languages, comprehension checks and multimedia if your study needs them, and ask to see the exported evidence for a signed consent. The answers show quickly whether a tool was built for informed consent or adapted from general document signing. For decentralised studies, see the DCT consent template.
It depends on the study. General e-signature tools suit simple, low-risk consent; enterprise suites suit large global programmes; unified EDC and eConsent platforms suit most small and mid-sized studies.
FDA and OHRP have published guidance on electronic informed consent. Outside the US, acceptance depends on national rules and ethics committees.
Yes. In Capture, participants sign on their own device after confirming a one-time email code.
In Capture, optional witness and legally authorised representative signatures are supported.
Capture links each signature cryptographically to the document content at signing and exports a signed PDF with the audit trail.
Yes. The free sandbox has every feature.
Sign a test consent in the free sandbox today.