eConsent for Decentralized Clinical Trials

eConsent for decentralized clinical trials: electronic consent with 21 CFR Part 11–aligned controls. End-to-end remote workflow with data capture and patient touchpoints.

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

Overview

eConsent for Decentralized Clinical Trials

eConsent for decentralized clinical trials supports electronic informed consent in DCTs—where participants may complete consent remotely with version control, e-signature, and full audit trail. End-to-end remote workflow spans consent, data capture, and patient touchpoints. Operational issues with paper consent and separate systems create two audit trails. Capture provides eConsent in the same platform as EDC and ePRO—one audit trail for consent and data capture, built for decentralized and hybrid trials.

What eConsent for DCTs is and why teams want it

Decentralized trials need consent that participants can complete remotely—with version control, e-signature, and full audit trail. When eConsent is in the same platform as EDC and ePRO, the entire remote workflow—consent, data capture, patient touchpoints—is in one audit trail.

End-to-end remote workflow for DCTs

  • Remote consent with version control and e-signature; full audit trail
  • Consent, data capture, and patient-reported data in one platform and one audit trail
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security for all touchpoints
  • Support for decentralized and hybrid trial designs
  • Documentation to support sponsor validation when required (Enterprise)

Operational issues with paper consent and separate systems

  • Paper consent doesn’t support decentralized participation
  • Separate consent system: two audit trails and no single view of remote workflow
  • Need for one platform for consent, CRFs, and ePRO with one audit trail
  • Capture: eConsent in same platform as EDC and ePRO; end-to-end remote workflow

Capture approach to eConsent for DCTs

  • eConsent in same platform as EDC and ePRO; one audit trail for consent and data capture
  • End-to-end remote workflow across consent, data capture, and patient touchpoints
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore eConsent or book a demo

Related

Decentralized clinical trial softwareRemote patient consent for clinical trialsFeatures

FAQ

Questions we hear a lot

What is eConsent for decentralized clinical trials?
eConsent for DCTs supports electronic consent in decentralized trials—with 21 CFR Part 11–aligned controls. Capture includes eConsent in the same platform as EDC and ePRO, supporting end-to-end remote workflow.
How does eConsent work in DCTs?
Capture includes eConsent and EDC in one platform. Consent and data capture share one audit trail, so remote consent and subsequent data capture are traceable end to end for DCTs.
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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