eConsent moves the informed consent process onto a screen: the information, the conversation, the signature and the record. This guide explains what it is and is not, how a consent session works, what regulators say and how to pick a system. It is an explainer; the product pages cover specific features.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Invitation
Participant opens a link or scans a code
Read
Information shown in sections
Discuss
Questions asked and answered by staff
Sign
Participant signs on screen, identity confirmed
Countersign
Investigator or delegate signs
Copy
Participant receives a copy; record stored
eConsent in brief
Definition
Informed consent is the process through which a person learns about a study and voluntarily agrees to take part. It has always been more than a signature: the participant needs adequate information, time to consider, a chance to ask questions and freedom from pressure. A form documents that the process took place. eConsent keeps all of that and changes the medium.
In practice an eConsent system presents the participant information electronically, often in short sections with plain-language headings, sometimes with diagrams or video. It records that the participant has viewed the content, captures their signature (and the signature of the person who conducted the discussion), stores the exact version signed and produces a copy. Better systems add comprehension questions, identity verification, role-based access for staff and an audit trail.
It is not a substitute for human contact. Regulators and ethics committees expect that participants can ask questions and receive answers from someone knowledgeable. It is also not a data-protection decision: consent to participate in research is a different thing from a GDPR legal basis for processing personal data, which many trials handle separately.
Comparison
| Aspect | Paper process | eConsent |
|---|---|---|
| Presentation | Long printed document | Sections, headings, optional visuals, one version shown |
| Version control | Risk of an old form in a drawer | Single approved version shown, versions recorded |
| Signature | Wet ink, initials per page | Electronic signature with identity and intent controls |
| Completeness | Missed initials or dates found at monitoring | Required steps enforced before completion |
| Copy to participant | Photocopy | PDF generated at signing |
| Remote participation | Post or courier | Possible with the right identity and discussion process |
| Audit trail | Manual file review | Time-stamped events stored with the record |
| Cost and effort | Printing, scanning, filing | Set-up effort, then lower handling |
Benefits depend on how well the process is designed and approved. A badly designed eConsent flow can be worse than a good paper one.
How it works
The study team writes the consent content (see how to write an eConsent form), the IRB or ethics committee approves it and the approved version is loaded into the system.
The participant is given access by a link or code, in clinic or remotely. Their identity is checked in a way that suits the risk of the study.
Content is shown in sections. The participant can go back, and the system may log what was viewed.
The investigator or delegate talks with the participant, in person, by phone or by video, and answers questions. The system should let staff record that this took place.
The participant signs electronically and staff countersign. Some studies add a witness or a legally authorised representative.
The signed document, signature data, timestamps and version are kept. The participant receives a copy.
The consent status should be visible to site staff before screening procedures, and ideally sit beside the participant's data in the same system.
Load a consent template, walk through a test session and export the signed PDF. The free sandbox has every feature, with no credit card and no time limit.
Regulation
This is a summary; the details and your obligations depend on where the study runs. For the regulation texts mapped in detail, read the electronic informed consent regulations guide.
United States. FDA and the HHS Office for Human Research Protections issued joint "Use of Electronic Informed Consent: Questions and Answers" (final December 2016). It explains that electronic consent can meet the requirements of the regulations for informed consent and IRB review and that, where FDA rules apply, electronic signatures should come from systems that meet Part 11 expectations. FDA also has a general informed consent guidance (August 2023) and a Q&A on electronic systems, records and signatures in clinical investigations (final October 2024). Check the current texts.
European Union. The Clinical Trials Regulation sets principles for informed consent, and member states and ethics committees apply them. A recommendation paper on decentralised elements published by EMA, HMA and the Commission in December 2022 discusses electronic consent but is not binding. Ask the ethics committee in each country what it accepts, particularly for remote signatures.
Good clinical practice. ICH E6 requires that the consent process and documents are approved and that the participant is informed before taking part. Treat the current E6 text as the baseline, and see ICH E6(R3) for clinical trial teams.
Data protection. Where GDPR applies, you also need a lawful basis for processing personal data and clear information about it. This is a separate decision from the participation consent.
Choosing
Start from your process and your ethics committee, then compare systems against a short list of requirements. The best-looking demo is not the best choice if the signature controls are weak or the record cannot be exported. For a shortlist, see best eConsent software and the buying view in eConsent software for clinical trials.
Ask each vendor, and test in a sandbox:
Capture eConsent is part of the same platform as EDC and ePRO. See the Capture eConsent product page for the full feature description. In outline:
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Rollout
Describe the process, identity checks and the screens, and ask for feedback before final submission.
Train staff to use the system as a support for discussion, not as a replacement for it.
Some participants prefer paper. Decide whether your study allows it and how both routes are recorded.
Run test consents from start to finish, including countersignature and export.
Record which participant signed which version and when a new version applies.
Know where signed consents are stored and who can open them. See remote patient consent for remote workflows.
eConsent is the use of electronic systems to present informed consent information, capture the participant's and staff signatures, store the signed version and give the participant a copy. It supports the consent process rather than replacing the discussion with the study team.
It can be, when the process meets the applicable rules. In the US, FDA and OHRP have published Q&A explaining how electronic consent can satisfy the regulations. In the EU, acceptance depends on the member state and ethics committee. Your IRB or ethics committee approves the process.
No. A signature is one step. eConsent covers the information presentation, identity, discussion, signatures, version control and record keeping.
No. Many studies use it on a tablet in clinic. It can also be used remotely when the identity and discussion steps are designed for it and approved.
For FDA-regulated studies, the joint Q&A says Part 11 generally applies where the consent and IRB regulations apply, so electronic signatures should come from a system with Part 11 controls. Confirm with your sponsor and IRB.
It varies by vendor and model. Capture has a free sandbox and you pay when you go live with real participants; ask for terms in writing. See eConsent cost per study for what to count.
This page explains the concept, regulation and selection. The Capture eConsent page describes the product features, signature workflow and templates.
Keep exploring
Capture eConsent
Product page.
eConsent software for clinical trials
Buying view.
Electronic informed consent regulations guide
Regulation text mapped.
How to write an eConsent form
Drafting the content.
Remote patient consent
Remote workflows.
Best eConsent software
Shortlist.
Consent template library
Starter templates.
eConsent cost per study
Costs to count.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.