EDC for Behavioral Health Studies

EDC for behavioral health studies: mental health, ePRO, and 21 CFR Part 11–aligned controls in one platform.

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

Overview

EDC for Behavioral Health Studies

Behavioral health studies evaluate mental health, substance use, and behavioral interventions with clinician-assessed and patient-reported instruments. Your EDC must support consent, CRFs, ePRO for validated scales and questionnaires, and full auditability for regulatory and publication use. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so behavioral health study teams can capture clinical and PRO data with one audit trail.

Why behavioral health studies need the right EDC

Behavioral health studies rely heavily on validated PRO instruments and often sensitive data. You need one system that handles consent, CRFs, and ePRO with the same audit trail and access controls, plus HIPAA-aligned security. Standalone ePRO systems often don’t integrate with EDC. Capture integrates ePRO with EDC and eConsent so behavioral health endpoints are captured with the same controls and audit history as clinical data.

Common behavioral health study workflow

Protocol and consent; ethics and regulatory approvals
Site activation and enrollment
Baseline and on-treatment; clinician and patient-reported instruments
Safety and AE capture; suicidality and crisis protocols as required
Data review and query resolution
Database lock and export for analysis and regulatory use

Traditional tool pain points

Separate ePRO and EDC systems; no single audit trail
High cost for mental health–specific or PRO-focused vendors
Limited flexibility for scale and instrument changes
Concerns about data security and HIPAA for sensitive PRO data

How Capture supports behavioral health studies

Unified EDC with eConsent and ePRO; flexible forms for scales and assessments
One platform and one audit trail; HIPAA-aligned security for sensitive data
21 CFR Part 11–aligned controls; export for analysis and regulatory use
Documentation for sponsor validation (Enterprise)

ePRO for patient-reported outcome studies EDC for quality of life studies Features

FAQ

Questions we hear a lot

Is Capture suitable for behavioral health studies?

Yes. Capture supports behavioral health studies with flexible EDC, eConsent, and ePRO. You get 21 CFR Part 11–aligned controls and HIPAA-aligned security for sensitive PRO data.

Can we use ePRO for mental health instruments?

Yes. Capture includes ePRO and eCOA. Validated scales and questionnaires can be configured and scheduled. Data is captured with the same audit and security controls as the rest of the study.

What about HIPAA for sensitive data?

Capture is designed with HIPAA-aligned security and 21 CFR Part 11–aligned controls. We provide documentation to support sponsor validation when required (Enterprise).

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