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Participant records contain all data collected for a participant, including questionnaire responses, status history, and documentation.

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Record Structure

Each participant record includes:

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Viewing Records

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Participant Summary

The summary view shows:
  • Current status and pathway progress
  • Outstanding items (incomplete forms, pending queries)
  • Recent activity

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Questionnaire Responses

View completed and in-progress questionnaires:
  • Grouped by visit or time point
  • Status indicators (in progress, completed, verified)
  • Data entry timestamps

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Record Status

Questionnaire responses have their own status:

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Data Entry

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Entering Data

1

Open Questionnaire

Navigate to the participant and select a questionnaire.
2

Enter Data

Complete the fields according to the form design.
3

Save Progress

Save in progress at any time. Data is preserved.
4

Complete

Mark as complete when all required fields are filled.

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Editing Data

After submission:
  • Site team can edit if no queries are open
  • Edits are tracked in the audit trail
  • Reason for change may be required
All data changes are recorded with timestamps and user identification for audit purposes.

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Record Workflow

The typical record workflow:

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Alternative Flows

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Viewing Record Details

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Field-Level Information

For each field, view:
  • Current value
  • Entry timestamp
  • Who entered the data
  • Change history (if modified)

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Audit Trail

The record audit trail shows:
  • All data entry events
  • Value changes
  • Status transitions
  • User actions
Navigate to the participant record and click “Audit Trail” to view the complete history of changes for that participant.

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Data Validation

Records may include validation:
  • Required field checks
  • Range validation (min/max values)
  • Conditional logic (fields appearing based on other answers)
  • Calculated fields (auto-computed from other values)

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Missing Data

Track missing mandatory fields:
  • Records with missing required fields are flagged
  • Cannot be marked complete until all required fields are filled
  • Study team can view missing data reports

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Attachments and Documents

Upload supporting documents:
  • Source documents
  • Consent forms
  • Images or scans
1

Open Document Section

Navigate to participant > Documents.
2

Upload

Click upload and select the file.
3

Add Metadata

Provide document title and type.

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Best Practices

Enter data close to the time of collection for accuracy.
Save progress regularly to avoid data loss.
Double-check entries before marking complete.
Always provide clear reasons for any data corrections.

Data Entry

Detailed data entry procedures.

Data Quality

Query management and verification.