Record Structure
Each participant record includes:| Component | Description |
|---|---|
| Demographics | Basic participant information and identifiers |
| Status History | Timeline of status changes |
| Questionnaire Responses | CRF data organized by pathway |
| Documents | Uploaded files and attachments |
| Queries | Data quality queries and resolutions |
| Audit Trail | Complete history of all changes |
Viewing Records
Participant Summary
The summary view shows:- Current status and pathway progress
- Outstanding items (incomplete forms, pending queries)
- Recent activity
Questionnaire Responses
View completed and in-progress questionnaires:- Grouped by visit or time point
- Status indicators (in progress, completed, verified)
- Data entry timestamps
Record Status
Questionnaire responses have their own status:| Status | Code | Description |
|---|---|---|
| In Progress | in-progress | Data entry not complete |
| Completed (Site) | completed-site | Site has submitted the record |
| Queries in Progress | needs-correction | Has open queries requiring response |
| Verified (Study Team) | verified-study-team | Data reviewed and verified |
| Signed (Site) | signed-site | Signed by authorized signer |
Data Entry
Entering Data
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.
Record Workflow
The typical record workflow:Alternative Flows
| Scenario | Flow |
|---|---|
| Query Raised | Completed → Queries in Progress → Completed (after resolution) |
| Correction Needed | Verified → Queries in Progress → Verified (after correction) |
Viewing Record Details
Field-Level Information
For each field, view:- Current value
- Entry timestamp
- Who entered the data
- Change history (if modified)
Audit Trail
The record audit trail shows:- All data entry events
- Value changes
- Status transitions
- User actions
Accessing Audit Trail
Accessing Audit Trail
Navigate to the participant record and click “Audit Trail” to view the complete history of changes for that participant.
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)
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
Attachments and Documents
Upload supporting documents:- Source documents
- Consent forms
- Images or scans
Best Practices
Complete Entries Promptly
Complete Entries Promptly
Enter data close to the time of collection for accuracy.
Use Save Frequently
Use Save Frequently
Save progress regularly to avoid data loss.
Review Before Completing
Review Before Completing
Double-check entries before marking complete.
Document Corrections
Document Corrections
Always provide clear reasons for any data corrections.
Related
Data Entry
Detailed data entry procedures.
Data Quality
Query management and verification.