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Documentation Index

Fetch the complete documentation index at: https://docs.carelane.io/llms.txt

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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

TypeImplementation
In TransitTLS 1.2+ for all connections
At RestAES-256 encryption for stored data
DatabaseEncrypted database storage
BackupsEncrypted backup storage

Access Controls

ControlPurpose
AuthenticationVerify user identity
AuthorizationControl resource access
Role-Based AccessPermission by role
Session ManagementSecure session handling

Authentication

Login Security

FeatureDescription
Password RequirementsStrong password policies
SSO SupportGoogle, Microsoft integration
Session TimeoutAutomatic logout after inactivity

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:
AspectImplementation
ProviderEnterprise-grade cloud
RegionsConfigurable data residency
RedundancyMultiple availability zones
BackupsRegular automated backups

Data Isolation

LevelIsolation
OrganizationSeparate data contexts
StudyStudy-specific access
PHISpecial handling for sensitive data

PHI Handling

Protected Health Information receives special treatment:
MeasurePurpose
Access LoggingTrack all PHI access
MinimisationCollect only needed PHI
EncryptionAdditional encryption for PHI
Access ControlStrict role requirements

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:
MeasureHow It Works
Audit TrailsComplete change history
Version ControlTrack all modifications
ValidationPrevent invalid data
ChecksumsDetect data corruption

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

ActionImportance
Strong PasswordsFirst line of defense
Don’t Share CredentialsMaintain accountability
Report ConcernsEarly detection
Follow PoliciesConsistent protection

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.