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Participants are the research subjects enrolled in your clinical study. Carelane provides tools to manage the full participant lifecycle from enrollment through study completion.

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Participants Overview

Enrollment

Add new participants to your study.

Participant Records

Manage participant data and CRFs.

Participant Pathways

Define the participant journey through the study.

Participant Status

Track and manage participant status transitions.

CRF Signing

Electronic signature workflows for CRFs.

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Participant Lifecycle

Participants progress through defined states: See Participant Status for the complete status reference.

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Participant Identification

Each participant is identified by:
PHI collection is configured at the study level. Only enabled PHI fields are available for data entry.

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Working with Participants

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Viewing Participants

Access participants from:
  • Study > Participants: All participants across sites
  • Site > Participants: Participants at a specific site
Filter by:
  • Status
  • Site
  • Arm assignment
  • Pathway progress

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Participant Details

Click a participant to view:
  • Basic information and identifiers
  • Current status and history
  • Pathway progress
  • CRF completion status
  • Query status

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Data Collection

Participant data is collected through:
  • Questionnaires: Structured data collection forms (CRFs)
  • Pathways: Scheduled sequences of questionnaires
  • Ad-hoc Forms: Additional data collection as needed

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Participant Data Flow

1

Enrollment

Site creates participant record with basic information.
2

Pathway Assignment

Participant is assigned a pathway defining their data collection schedule.
3

Data Entry

Site team enters data into questionnaires per the pathway.
4

Review

Study team reviews submitted data.
5

Verification

Data reviewer verifies data quality.
6

Sign-off

Authorized signer approves completed CRFs.

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Best Practices

Use consistent pseudonym formats across sites (e.g., “Site-Participant” numbering).
Enter data promptly after collection to maintain data quality.
Keep participant status current to accurately reflect their study progress.
Address data queries promptly to maintain clean data.