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Protocol compliance means conducting the study according to the approved protocol. Carelane provides tools to support and monitor compliance.

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Protocol Elements in Carelane

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Mapping Protocol to Configuration

Protocol SectionCarelane Configuration
ObjectivesStudy objectives
Study DesignArms, design type
EligibilityScreening questionnaires
Schedule of ActivitiesParticipant pathways
AssessmentsQuestionnaires
Data CollectionCRF design

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Implementing Protocol Requirements

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Eligibility Criteria

Implement eligibility screening:
1

Create Screening Forms

Design questionnaires capturing inclusion/exclusion criteria.
2

Add to Pathway

Include in screening visit.
3

Review Process

Establish eligibility review procedures.
4

Document Decisions

Record eligibility determinations.

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Visit Schedule

Match pathway to protocol SoA:
ProtocolCarelane
Visit 1 - ScreeningScreening Visit in pathway
Visit 2 - BaselineBaseline Visit
Visit 3 - Week 4Week 4 Visit
Visit N - EOSEnd of Study Visit

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Required Assessments

Ensure all protocol assessments are captured:
  • Map each assessment to a questionnaire
  • Include all required data points
  • Match visit windows to protocol

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Deviation Management

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What is a Protocol Deviation?

Any departure from the approved protocol:
TypeExamples
EligibilityEnrolled ineligible participant
VisitMissed visit, visit out of window
AssessmentMissed required assessment
ProcedureIncorrect procedure performed

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Documenting Deviations

1

Identify Deviation

Recognize when deviation has occurred.
2

Document

Record what happened and why.
3

Assess Impact

Evaluate impact on participant safety and data.
4

Implement Corrections

Take corrective actions as needed.
5

Report

Report per protocol and regulatory requirements.

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Deviation Categories

SeverityCriteria
MajorAffects participant safety, data integrity, or rights
MinorAdministrative or procedural; no safety/data impact

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Compliance Monitoring

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Site-Level Compliance

Monitor compliance indicators:
IndicatorWhat to Look For
Visit CompletionVisits conducted within windows
Assessment CompletionRequired assessments performed
Query RateData quality indicators
Deviation ReportsFrequency and severity

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Study-Level Compliance

Track overall study compliance:
  • Protocol deviation trends
  • Site comparison
  • Systemic issues identification

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Protocol Amendments

When the protocol changes:
1

Receive Amendment

Obtain approved protocol amendment.
2

Assess Impact

Determine impact on Carelane configuration.
3

Update Configuration

Modify questionnaires, pathways, or settings.
4

Communicate

Notify sites of changes.
5

Train

Provide training on new requirements.
6

Document

Record amendment implementation.
Some configuration changes may affect existing data or require migration. Plan amendments carefully.

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Tools for Compliance

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Pathway Windows

Configure visit windows to flag out-of-window visits:
  • Target visit dates
  • Acceptable ranges
  • Overdue alerts

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Required Fields

Make critical assessments required:
  • Cannot complete without entering
  • Reduces missing data

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Validation Rules

Add validation to catch errors:
  • Range checks
  • Logical checks
  • Cross-field validation

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Best Practices

Configure Carelane to match the protocol exactly, including terminology.
Ensure all site staff understand protocol requirements.
Don’t wait for issues; monitor compliance continuously.
Document deviations as soon as they’re identified.

Monitoring

Site and data monitoring.

Participant Pathways

Configure study schedules.