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Carelane is designed to support compliance with major regulatory frameworks for clinical research and data protection.

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Regulatory Frameworks

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21 CFR Part 11

FDA regulation for electronic records and signatures:
RequirementCarelane Support
Audit TrailsComplete change history
Electronic SignaturesAuthenticated signatures
User IdentificationUnique user accounts
System Access ControlsRole-based permissions
Authority ChecksPermission verification

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HIPAA

Healthcare data protection:
RequirementCarelane Support
Access ControlsRole-based access
Audit ControlsAccess logging
Transmission SecurityEncryption in transit
Data IntegrityChange tracking

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GDPR

European data protection:
RequirementCarelane Support
Lawful ProcessingConsent documentation
Data MinimizationConfigurable PHI
Access RightsData export
Data ProtectionSecurity measures

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ICH GCP

Good Clinical Practice:
RequirementCarelane Support
Protocol ComplianceStructured data collection
Source DocumentationAudit trails
Data IntegrityValidation and verification
MonitoringReview capabilities

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Electronic Signatures

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Signature Requirements

21 CFR Part 11 requires:
RequirementImplementation
Unique IDUser-specific accounts
Signature MeaningClear intent capture
TimestampDate and time recorded
LinkageBound to signed record

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Using Electronic Signatures

1

Complete Record

Finish data entry and verification.
2

Review

Review data before signing.
3

Sign

Apply electronic signature.
4

Record

Signature is recorded with timestamp.

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Audit Trail Requirements

Regulatory audit trail requirements:
RequirementHow Met
Computer-generatedAutomatic logging
SecureImmutable records
Date/time stampedUTC timestamps
Original and modifiedBefore/after values
Not obscuredPrevious values visible

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Data Integrity

ALCOA+ principles:
PrincipleImplementation
AttributableUser identification
LegibleClear data display
ContemporaneousTimestamps
OriginalPrimary data capture
AccurateValidation rules
CompleteRequired fields
ConsistentStandard formats
EnduringData retention
AvailableExport capabilities

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System Validation

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Validation Approach

Carelane undergoes validation including:
  • Requirements documentation
  • Design documentation
  • Testing documentation
  • Validation reports

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Your Responsibilities

ResponsibilityActions
QualificationAssess fitness for purpose
SOPsDevelop procedures for use
TrainingTrain users appropriately
OngoingMonitor and maintain

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Compliance Documentation

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Available Documentation

DocumentPurpose
Security OverviewSecurity measures
Validation SummaryValidation approach
Compliance MatrixRegulatory mapping

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Your Documentation

Maintain your own:
  • SOPs for Carelane use
  • Training records
  • Validation records
  • Audit documentation

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Regulatory Inspections

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Preparing for Inspections

1

Document System Use

Maintain records of how Carelane is used.
2

Export Audit Trails

Prepare audit trail exports.
3

Review Access

Document who had access and why.
4

Prepare Training Records

Show user training documentation.

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During Inspections

Carelane supports:
  • Audit trail review
  • Data export
  • Access log review
  • Signature verification

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Best Practices

Know which regulations apply to your study.
Maintain complete documentation.
Ensure users understand compliance requirements.
Periodically review compliance status.

Audit Trails

Audit trail details.

CRF Signing

Electronic signatures.