eConsent for Multi-Site Clinical Trials

eConsent for multi-site clinical trials: electronic consent with 21 CFR Part 11–aligned controls. One platform across sites.

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

Overview

eConsent for Multi-Site Clinical Trials

eConsent for multi-site clinical trials lets you run electronic informed consent across sites with one version, e-signature, and full audit trail—with 21 CFR Part 11–aligned controls when integrated with EDC and ePRO. Multi-site trials need consistent consent versioning and one audit trail across sites. Operational issues with paper consent include version drift and site-to-site inconsistency. Capture provides eConsent in the same platform as EDC and ePRO—one audit trail across all sites.

What eConsent for multi-site trials is and why teams want it

Multi-site trials need consent with one version across sites, e-signature, and full audit trail. When eConsent is in the same platform as EDC and ePRO, you get one audit trail across sites; when it’s separate, you get integration cost and two audit trails.

Operational issues with paper consent

  • Paper consent: version drift across sites, transcription errors, no single audit trail
  • 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 across sites
  • Documentation to support sponsor validation when required (Enterprise)

Remote workflow and Capture fit

  • Paper consent doesn’t support multi-site consistency or remote workflows efficiently
  • Separate consent system: two audit trails and reconciliation across sites
  • 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 across sites

Capture approach to eConsent for multi-site trials

  • eConsent in same platform as EDC and ePRO; one audit trail across all sites
  • 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

eConsent software for clinical trialsEDC with eConsentFeatures

FAQ

Questions we hear a lot

What is eConsent for multi-site clinical trials?
eConsent for multi-site trials supports electronic consent across sites with one version 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 for multi-site trials?
No. Capture includes eConsent. You can version and sign consent electronically across sites; 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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