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Data security encompasses the measures and controls that protect your clinical research data from unauthorized access, modification, or loss.

Data Protection Measures

Encryption

Access Controls

Authentication

Login Security

Multi-Factor Authentication

When available:
  • Additional verification step via an authenticator app (TOTP)
  • Backup recovery codes generated at enrolment — store these safely; each code works once and lets you sign in if you lose access to your authenticator
  • Reduces unauthorised-access risk
Recovery codes can be downloaded as a file or copied from the MFA setup screen. When you use one, it is consumed and an entry appears in your audit trail.
If you enabled MFA before backup codes were introduced, re-enrol from your user profile to generate a recovery code.

Data Storage

Cloud Infrastructure

Carelane uses enterprise cloud services:

Data Isolation

PHI Handling

Protected Health Information receives special treatment:

Reduced PHI Requests by Default

The participant enrolment form now requests fewer PHI fields by default. Essential fields (such as pseudonym and the study-configured status) remain pre-populated; optional PHI fields — for example subject name, medical record number, full date of birth, or subject initials — must be explicitly enabled per study. This supports data-minimisation requirements and reduces the compliance footprint of new studies.
Only enable PHI fields that are necessary for your study. Once PHI data is collected, retention and access rules apply even if the field is later disabled.

Data Integrity

Measures to ensure data integrity:

Incident Response

If a security incident occurs:
1

Detect

Automated monitoring detects issues.
2

Contain

Immediate containment actions.
3

Assess

Evaluate scope and impact.
4

Notify

Notify affected parties as required.
5

Remediate

Fix the underlying issue.

Your Role in Data Security

Best Practices

Use strong, unique passwords. Enable MFA if available.
Only enable PHI fields you actually need.
Protect exported files appropriately.
Report any security concerns immediately.

Access Control

Managing access permissions.

Audit Trails

Activity logging.