Digital Informed Consent Software

Digital informed consent software: electronic consent with version control, e-signature, and 21 CFR Part 11–aligned controls. Integrated with EDC and ePRO.

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

Overview

Digital Informed Consent Software

Digital informed consent software supports 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 version drift, transcription errors, and no single audit trail. Remote workflow requires consent that participants can complete with full traceability. Capture provides digital informed consent in the same platform as EDC and ePRO—one audit trail and same security.

What digital informed consent is and why teams want it

Digital informed consent is electronic consent with version control, e-signature, and full audit trail. Teams want it to simplify consent across sites and support remote participation. When consent 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
  • Digital consent: version control, e-signature, and full audit trail
  • 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: digital consent in same platform as EDC and ePRO; one audit trail

Capture approach to digital informed consent

  • Digital informed consent 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

eConsent software for clinical trialsEDC with eConsentFeatures

FAQ

Questions we hear a lot

What is digital informed consent software?
Digital informed consent software supports electronic 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 consent 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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