EDC for Clinical Trial Investigators

EDC for clinical trial investigators: selection criteria and fit for investigator-led studies. EDC with eConsent, ePRO, and 21 CFR Part 11–aligned controls.

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

Overview

EDC for Clinical Trial Investigators

EDC for clinical trial investigators must support investigator-led or site-led studies: one platform for EDC, eConsent, and ePRO with 21 CFR Part 11–aligned controls and documentation for validation when required. This guide gives investigators selection criteria, a checklist, common mistakes, and how Capture fits. Use it to build a shortlist or internal case for selecting software.

Selection criteria for investigators

Investigators need: one platform for consent and data capture (and ePRO if required); 21 CFR Part 11–aligned controls and HIPAA-aligned security; ease of use for sites and participants; documentation to support validation when studies are regulated; and pricing and contract fit for investigator-led studies. Avoid assuming only sponsor or CRO-led systems are available; many platforms support investigator-led use.

Checklist for investigator EDC selection

Integrated eConsent, ePRO, and EDC in one platform and one audit trail
21 CFR Part 11–aligned controls and HIPAA-aligned security
Ease of use for sites and participants; support for investigator-led studies
Documentation and support for validation when required
Pricing and contract fit for investigator-led studies
Export for analysis and publication or regulatory use

Common mistakes for investigators selecting EDC

Choosing software built only for large sponsor or CRO-led trials
Not checking validation documentation for regulated investigator-led studies
Underestimating site and participant ease of use
Not clarifying pricing and contract for investigator-led use

Where Capture fits for investigators

Single platform for EDC, eConsent, ePRO, and safety; built for early-phase and small studies
21 CFR Part 11–aligned controls and HIPAA-aligned security; documentation for validation (Enterprise)
Book a demo to evaluate fit for investigator-led studies

EDC for academic clinical trials EDC for investigator-initiated trials Features

FAQ

Questions we hear a lot

What EDC fits clinical trial investigators?

Look for one platform for EDC, eConsent, and ePRO with 21 CFR Part 11–aligned controls and support for investigator-led studies. Capture supports investigator-led use; book a demo to evaluate fit.

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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