eConsent Without Paper Forms

eConsent without paper forms: 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

eConsent Without Paper Forms

eConsent without paper forms means electronic informed consent only—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. Teams want to eliminate paper forms for consent. Capture provides eConsent in the same platform as EDC and ePRO—one audit trail and same security, no paper forms required.

What eConsent without paper forms is and why teams want it

eConsent without paper forms is fully electronic consent: version control, e-signature, and full audit trail. Teams want it to eliminate paper, simplify consent across sites, and support remote participation. When eConsent 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
  • eConsent: version control, e-signature, and full audit trail; no paper forms
  • 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: eConsent in same platform as EDC and ePRO; no paper forms

Capture approach to eConsent without paper forms

  • eConsent in same platform as EDC and ePRO; one audit trail; no paper forms required
  • 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 trialsDigital informed consent softwareFeatures

FAQ

Questions we hear a lot

What is eConsent without paper forms?
eConsent without paper forms means fully electronic consent—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; no paper forms required.
Do I need paper consent forms with Capture?
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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