How to Digitize Clinical Trial Consent Forms

How to digitize clinical trial consent forms: steps, common blockers, and tool options. eConsent with 21 CFR Part 11–aligned controls.

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

Overview

How to Digitize Clinical Trial Consent Forms

You digitize clinical trial consent forms by using eConsent in the same platform as EDC and ePRO—so consent is version-controlled, e-signed, and captured with one audit trail and 21 CFR Part 11–aligned controls. Quick answer: use one platform that includes eConsent. Steps: define consent documents and versioning; choose one platform for eConsent and EDC; build study and run validation/UAT if regulated; launch. Common blockers: paper consent, separate consent system. Tool options: look for integrated eConsent, same platform as EDC. Capture fit: one platform for EDC, eConsent, ePRO; version control and e-signature with full audit trail.

Quick answer and steps

Digitizing consent means eConsent in the same platform as EDC and ePRO—so consent has version control, e-signature, and one audit trail. Lead with a direct answer and numbered steps.

Steps/process

  • Define consent documents and versioning
  • Choose one platform for eConsent and EDC
  • Build study; run validation/UAT if regulated
  • Launch; consent captured with version control and e-signature
  • Documentation to support sponsor validation when required (Enterprise)

Common blockers

  • Paper consent; no version control or single audit trail
  • Separate consent system; two audit trails
  • Need for one platform for consent and data capture with one audit trail
  • Capture: eConsent in same platform as EDC and ePRO

Tool options and Capture fit

  • One platform for EDC, eConsent, ePRO; version control and e-signature with full audit trail
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore workflow or book a demo

Related

eConsent software for clinical trialsDigital informed consent softwareFeatures

FAQ

Questions we hear a lot

How do I digitize clinical trial consent forms?
Use one platform that includes eConsent in the same system as EDC and ePRO so consent has version control, e-signature, and one audit trail. Capture includes eConsent; explore workflow or book a demo.
Is Capture 21 CFR Part 11–aligned?
Yes. Capture is designed with 21 CFR Part 11–aligned controls and HIPAA-aligned security. We provide documentation to support sponsor validation when required (Enterprise).

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