EDC with eConsent

EDC with eConsent: one platform for data capture and electronic informed consent with 21 CFR Part 11–aligned controls.

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

Overview

EDC with eConsent

EDC with eConsent means electronic data capture and electronic informed consent in the same platform—one audit trail, version control for consent documents, and electronic signature without a separate consent vendor. Teams want it to simplify compliance and give sites one system for consent and data capture. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned security.

Why teams want EDC with eConsent

Separate consent and EDC systems mean two audit trails and complex handoffs. Built-in eConsent gives you version control, e-signature, and full audit trail in the same platform as CRFs—same security and one build. Operational benefits include faster setup, simpler monitoring, and consistent data integrity for regulatory and ethics review.

Operational benefits of EDC with eConsent

  • One platform and one audit trail for consent and CRFs
  • Consent versioning and e-signature without separate vendor
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security for all data
  • Simpler monitoring and inspection readiness; export for analysis and regulatory use
  • Documentation to support sponsor validation when required (Enterprise)

What slows teams down without built-in eConsent

  • Separate consent system and integration or manual handoff
  • Two audit trails and reconciliation for consent and data
  • Higher cost and longer implementation for consent workflows
  • Monitoring and compliance review across multiple systems

Capture workflow for EDC with eConsent

  • Built-in eConsent: version control, e-signature, and full audit trail in same platform as EDC and ePRO
  • One audit trail for all data; 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Study builder to configure visits, forms, and consent; support for consent amendments
  • Export for analysis and regulatory use; documentation for validation (Enterprise)

Related

EDC with built-in ePROEDC with randomizationFeatures

FAQ

Questions we hear a lot

What is EDC with eConsent?
EDC with eConsent means electronic data capture and electronic informed consent in the same platform—one audit trail, version control, and e-signature. Capture includes eConsent in the same system as EDC and ePRO.
Do I need a separate eConsent vendor?
No. Capture includes eConsent. Consent documents can be versioned and signed 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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