eConsent for Academic Clinical Research

eConsent for academic clinical research: electronic consent with 21 CFR Part 11–aligned controls. Lean teams, budget sensitivity, investigator-led workflows.

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

Overview

eConsent for Academic Clinical Research

eConsent for academic clinical research supports investigator-led and academic trials: 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. Academic studies often have lean teams, budget sensitivity, and investigator-led workflows—they need one platform without enterprise consent pricing or separate vendors. Operational issues with paper consent include version drift and no single audit trail. Capture provides eConsent in the same platform as EDC and ePRO—one audit trail, built for academic and investigator-led use.

What eConsent for academic research is and why teams want it

Academic and investigator-led studies need electronic consent with full audit trail and 21 CFR Part 11–aligned controls—with lean teams, budget sensitivity, and investigator-led workflows. 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
  • Remote and 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
  • Pricing and support that fit lean teams and academic budgets
  • 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 cost for lean teams
  • Need for one platform for consent, CRFs, and ePRO with one audit trail
  • Capture: eConsent in same platform as EDC and ePRO; fit for academic and investigator-led use

Capture approach to eConsent for academic research

  • eConsent in same platform as EDC and ePRO; one audit trail; fit for academic and investigator-led use
  • 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

EDC for academic clinical trialseConsent software for clinical trialsFeatures

FAQ

Questions we hear a lot

What is eConsent for academic clinical research?
eConsent for academic research supports electronic consent in investigator-led or academic trials—with 21 CFR Part 11–aligned controls. Capture includes eConsent in the same platform as EDC and ePRO, with fit for lean teams and academic workflows.
Do I need a separate eConsent vendor for academic studies?
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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