Clinical Trial Pre-Screening Tools

Clinical trial pre-screening tools: eligibility and pre-screening in one platform with 21 CFR Part 11–aligned controls.

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

Overview

Clinical Trial Pre-Screening Tools

Clinical trial pre-screening tools support eligibility and pre-screening in one workflow—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and eConsent. Common blockers include manual pre-screening and paper forms. What software changes is one platform for pre-screening and enrollment—so eligibility checks flow into consent and CRFs. Capture provides pre-screening and enrollment in the same platform as EDC, eConsent, and ePRO—one audit trail and same security.

What this workflow covers

Pre-screening covers initial eligibility checks before full screening and consent. When pre-screening is in the same platform as EDC and eConsent, you get one audit trail; when it’s separate, you get integration cost and two audit trails.

Common blockers and what software changes

  • Manual pre-screening and paper forms: slow, no single audit trail
  • One platform for pre-screening, consent, and enrollment; one audit trail
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and eConsent
  • Pre-screening data in same system as CRFs
  • Documentation to support sponsor validation when required (Enterprise)

Common blockers

  • Manual pre-screening slows enrollment
  • Separate pre-screening system: two audit trails and reconciliation
  • Need for one platform for pre-screening, consent, and data capture with one audit trail

Capture workflow for pre-screening

  • Pre-screening and enrollment in same platform as EDC and ePRO; one audit trail
  • Study builder to configure eligibility and pre-screening workflows
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore workflow or book a demo

Related

Online patient screening for clinical trialsPatient eligibility screening softwareFeatures

FAQ

Questions we hear a lot

What are clinical trial pre-screening tools?
Pre-screening tools support initial eligibility checks in the same platform as consent and data capture—with 21 CFR Part 11–aligned controls. Capture includes pre-screening and enrollment in the same platform as EDC, eConsent, and ePRO.
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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