Informed consent, signed from anywhere
E-Consent
Send versioned consent documents that participants read and sign on their phone, with the audit trail a monitor expects.
What you get
- Section-by-section acknowledgment and an optional comprehension check
- Typed or drawn signatures with LAR, witness, and investigator countersignature
- Version control with IRB metadata — a new version retires the old one and flags re-consent
- Declining and withdrawing are first-class, recorded actions
- Full audit trail: who signed, when, from where, and the exact wording they saw
Why it matters
Consent is the step that stalls enrollment. Build your IRB-approved document in Trialflow, send it by email or SMS, and let the participant work through it at their own pace — acknowledging each section, answering a comprehension check, and signing. Your investigator countersigns from the same record, and the whole trail is waiting when a monitor asks.
See it in action
E-Consent, inside Trialflow
FAQ
E-Consent questions, answered
Do participants need an account or an app?+
No. They get a private link by email or SMS, open it on whatever device they have, and read and sign there. The same link stays available afterwards so they can re-read the document or withdraw.
How do you handle a protocol amendment?+
Publish a new version. The previous one is retired, the wording locks as soon as anyone has signed it, and consents captured against the old version are flagged for re-consent — so you always know who is consented to which version.
What exactly is captured for the audit trail?+
Every signature stores the signer, their capacity (participant, legally authorized representative, witness, or investigator), the timestamp, IP address, user agent, and the exact attestation text shown above the signature box. Section acknowledgments and each comprehension-check attempt are recorded too, and the document body is snapshotted onto the request when it is sent, so later edits can never change what someone agreed to.
Can someone decline or withdraw?+
Yes, and both are recorded actions rather than dead ends. Declining is offered on the same screen as signing; withdrawing is available from the participant’s link after signing. Either one clears the standing consent flag and notifies your team.
Can we consent in person on a site device?+
Yes. Choose in-person delivery and Trialflow generates the link without transmitting it, so the participant can sign on a tablet at the site with the same acknowledgments and audit trail.
Is this 21 CFR Part 11 validated?+
The module is built around what a monitor or auditor asks for — attributable signatures, integrity of what was signed, evidence of comprehension, and a recorded right to say no. That gives you a defensible record; formal Part 11 validation remains a site and sponsor exercise on top of it, and we are happy to walk your QA team through the controls.
Can the consent document be shown in another language?+
Yes. Add per-language translations of the sections and the participant reads and signs in their language, with the same acknowledgments and audit trail.
See E-Consent in action
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