Consent that leaves a paper trail worth having.
Beacon drafts study-specific informed consent forms and tracks versions, so every participant record points to the exact consent they signed — and amendments never overwrite history.
Beacon drafts study-specific informed consent forms (ICFs) covering purpose, procedures, risks, benefits, alternatives, voluntary participation, withdrawal rights, data handling, and contact information. Final ICF language is approved by the reviewing IRB — Beacon prepares the materials; the IRB decides.
- Consent forms are versioned per study.
- Each participant’s consent record links to the exact text and date they accepted.
- Amendments preserve history without overwriting prior versions.
- HIPAA authorization language can be included where the study requires it.
- Withdrawal is honored on request, at any time.
Related: the regulatory affairs section covers IRB readiness packages and commercial IRB coordination.
Our eConsent policy
Consent is a regulatory and ethical act, not a checkbox. Our platform records who consented, to which version of which document, and when — and it keeps that record immutable so the consent trail is as strong at the end of the study as it was on day one.
What we do: versioned consent documents, electronic signature capture, timestamped audit records linking each participant to the exact text they accepted, amendment handling that preserves history, re-consent workflows when a protocol changes, and withdrawal honored at any time. HIPAA authorization language can be included where the study requires it.
What we don’t claim: the platform is designed to support consent workflows that satisfy regulatory expectations — it is not itself a legal determination. Whether a consent process satisfies 21 CFR Part 11, GCP, or your IRB’s requirements depends on your protocol, your IRB, and how the platform is configured; final determinations belong to your IRB and responsible parties. We’ll help you present your consent workflow for review honestly and completely.
Every consent document on the platform is retained per the study’s record-retention agreement, and participants may request their consent record at any time through the study team.
Setting up a study that needs consent workflows?
Start a draft and configure consent as part of study start-up, or ask us first.