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Participant pathways define the structured sequence of data collection activities that participants complete throughout the study. Pathways are the schedule of activities (SoA) implemented as actionable templates.

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What are Pathways?

A pathway is a template that defines:
  • Which questionnaires to complete
  • When to complete them (visits, time points)
  • The order of activities
  • Optional conditional logic

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Pathway Structure

Pathways organize activities into logical groups:

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Visits or Time Points

Activities grouped by study visit:
  • Screening Visit
  • Baseline Visit
  • Week 4 Visit
  • End of Study Visit

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Activity Types

TypeDescription
QuestionnaireData collection form (CRF)
TaskNon-data-collection activity
SignatureElectronic signature requirement

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Creating Pathways

See Pathway Templates for creating reusable pathway templates.

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Study-Specific Pathways

1

Navigate to Study Design

Open Study Design > Pathways.
2

Add or Import Pathway

Create a new pathway or import from a template.
3

Configure Structure

Add visits/groups and activities.
4

Set Timing

Configure time windows for each activity.
5

Save

Save the pathway for use in the study.

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Pathway Assignment

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During Enrollment

Select the pathway when creating a participant:
1

Add Participant

Start the enrollment process.
2

Select Pathway

Choose from available pathways.
3

Create

The pathway generates scheduled activities.

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Arm-Specific Pathways

Different arms can use different pathways:
  • Control arm: Standard observation pathway
  • Treatment arm: Intervention-specific pathway
Configure arm-pathway associations in study design.

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Pathway Progress

Track participant progress through the pathway:
IndicatorDescription
CompletedActivity finished
In ProgressActivity started
DueActivity within time window
UpcomingFuture activity
OverduePast time window

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Conditional Activities

Activities can be conditional:
  • Based on answers to previous questionnaires
  • Based on participant status
  • Based on arm assignment
In the pathway editor, select an activity and add conditions. Activities only appear when conditions are met.

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Modifying Participant Pathways

Individual participant pathways can be modified:

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Adding Activities

Add unscheduled activities:
  • Ad-hoc questionnaires
  • Unplanned visits
  • Additional assessments

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Skipping Activities

Mark activities as skipped with a reason:
  • Missed visit
  • Not applicable
  • Participant declined
Document reasons for all pathway modifications. These appear in the audit trail.

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Repeating Activities

Some activities may repeat:
  • Periodic assessments
  • Multiple treatment cycles
  • Ongoing monitoring
Configure repetition rules in the pathway template.

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Pathway Reports

Generate reports on pathway completion:
ReportDescription
Completion RatePercentage of activities completed
Overdue ActivitiesActivities past their window
Missing DataIncomplete questionnaires

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Best Practices

Design pathways to match your protocol’s schedule of activities exactly.
Set time windows that reflect actual clinical practice.
Use descriptive names that site staff will understand.
Test pathways with test participants before enrolling real participants.

Pathway Templates

Create reusable pathway templates.

Participant Status

Status transitions along the pathway.