Remote Patient Consent for Clinical Trials

Remote patient consent for 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

Remote Patient Consent for Clinical Trials

Remote patient consent for clinical trials lets participants complete informed consent electronically from any location—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and ePRO. End-to-end remote workflow spans consent, data capture, and patient touchpoints. Paper consent doesn’t support remote participation; 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, supporting remote and decentralized workflows.

What remote patient consent is and why teams want it

Remote patient consent allows participants to complete informed consent electronically without being on-site—with version control, e-signature, and full audit trail. Teams want it for decentralized and hybrid trials. 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

  • 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 trials
  • Documentation to support sponsor validation when required (Enterprise)

Operational issues with paper consent and separate systems

  • Paper consent doesn’t support remote 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 remote patient consent

  • 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

eConsent for decentralized clinical trialsDecentralized clinical trial softwareFeatures

FAQ

Questions we hear a lot

What is remote patient consent for clinical trials?
Remote patient consent lets participants complete informed consent electronically from any location—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 remote consent work with data capture?
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.
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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