eConsent Software for Clinical Trials

eConsent software for clinical trials: electronic informed consent with 21 CFR Part 11–aligned controls. Integrated with EDC and ePRO.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

Overview

eConsent Software for Clinical Trials

eConsent software for clinical trials lets you conduct electronic informed consent with version control, e-signature, and full audit trail—with 21 CFR Part 11–aligned controls when integrated with EDC and ePRO. Operational issues with paper consent include transcription errors, version drift, and no single audit trail. Remote workflow requires consent that participants can complete remotely with full traceability. Capture provides eConsent in the same platform as EDC and ePRO—one audit trail and same security.

What eConsent is and why teams want it

eConsent is electronic informed consent: version-controlled consent documents, e-signature, and full audit trail. Teams want it to simplify consent across sites and support remote participation. When eConsent is in the same platform as EDC and ePRO, you get one audit trail; when it’s separate, you get integration cost and two audit trails.

Operational issues with paper consent

  • Paper consent: version drift, transcription errors, no single audit trail
  • Remote and multi-site consent: need for one system with version control and e-signature
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and ePRO
  • Consent amendments and re-consent with full audit trail
  • Documentation to support sponsor validation when required (Enterprise)

Remote workflow and Capture fit

  • Paper consent doesn’t support remote or multi-site workflows efficiently
  • Separate consent system: two audit trails and reconciliation
  • Need for one platform for consent, CRFs, and ePRO with one audit trail
  • Capture: eConsent in same platform as EDC and ePRO; one audit trail

Capture approach to eConsent

  • eConsent in same platform as EDC and ePRO; one audit trail
  • Version control, e-signature, and consent amendments with full audit trail
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore eConsent or book a demo

Related

EDC with eConsentRemote patient consent for clinical trialsFeatures

FAQ

Questions we hear a lot

What is eConsent software for clinical trials?
eConsent software supports electronic informed consent with version control, e-signature, and full audit trail—with 21 CFR Part 11–aligned controls. Capture includes eConsent in the same platform as EDC and ePRO.
Do I need a separate eConsent vendor?
No. Capture includes eConsent. You can version and sign consent electronically; each consent event is recorded in the audit trail with the same controls as the rest of the study.
Is Capture 21 CFR Part 11–aligned?
Yes. Capture is designed with 21 CFR Part 11–aligned controls (electronic signatures, audit trails, access control) and HIPAA-aligned security. We provide documentation to support sponsor validation when required (Enterprise).

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