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Data submission is the process of marking data entry as complete and submitting it for review. This transitions data from “in progress” to the review workflow.

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Submission Process

1

Complete Data Entry

Fill in all required fields in the questionnaire.
2

Review Entry

Review all entered data for accuracy.
3

Validate

Ensure all validation rules pass.
4

Submit

Click “Complete” or “Submit” to finalize.

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Record Status Flow

After submission, records follow this workflow:

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Submission Requirements

Before submission is allowed:

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Required Fields

All required fields must be completed:
  • Indicated with required marker
  • Validation prevents submission if missing
  • Optional fields can be left blank

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Validation Rules

All validation must pass:
  • Range checks
  • Format validation
  • Cross-field validation

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Warnings vs. Errors

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What Happens After Submission

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Site View

After submission, site users:
  • Can view the submitted data
  • Cannot edit without reopening
  • See the submission timestamp

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Study Team View

Study team can:
  • Review submitted data
  • Raise queries for clarification
  • Verify the record
  • Send for signature

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Reopening Submitted Records

If changes are needed after submission:

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Before Verification

1

Navigate to Record

Open the submitted questionnaire response.
2

Reopen

Click “Edit” or “Reopen” (if available).
3

Make Changes

Update the data as needed.
4

Re-submit

Submit again after changes.

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After Verification

Changes to verified records:
  • May require query process
  • Resets verification status
  • Documented in audit trail
Reopening submitted records is tracked. Always document reasons for changes.

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Submission Timestamps

All submissions are timestamped:

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Audit Trail

Submission events are recorded:
  • Who submitted
  • When submitted
  • Any subsequent changes
  • Re-submissions
Access the audit trail from the record detail view.

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Batch Submission

Submit multiple records at once:
1

Select Records

From the participant list, filter for completable records.
2

Review

Ensure all records are ready for submission.
3

Bulk Submit

Submit all selected records.
Even with batch submission, ensure each record has been reviewed individually.

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Submission Notifications

Notifications can be configured for:
  • Study team: When new data is submitted
  • Site team: When queries are raised
  • Signers: When records need signature

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Best Practices

Always review data before submission to minimize queries.
Submit completed records promptly to keep the review process moving.
Resolve validation warnings before submission when possible.
If changes are needed after submission, document the reason clearly.

Data Quality

Review and verification process.

CRF Signing

Signature workflow after verification.