Validation

Trial Submission Studio validates your data against CDISC standards before export.

Validation Overview

flowchart LR
    subgraph Input
        DATA[Mapped Data]
    end

    subgraph Checks
        STRUCT[Structure<br/>Required variables]
        CT[Terminology<br/>Codelist values]
        CROSS[Cross-Domain<br/>Consistency]
    end

    subgraph Output
        ERR[Errors]
        WARN[Warnings]
        INFO[Info]
    end

    DATA --> STRUCT --> CT --> CROSS
    STRUCT --> ERR
    CT --> WARN
    CROSS --> INFO
    style ERR fill: #f8d7da, stroke: #721c24
    style WARN fill: #fff3cd, stroke: #856404
    style INFO fill: #d1ecf1, stroke: #0c5460

Validation checks ensure your data:

• Conforms to SDTM structure
• Uses correct controlled terminology
• Meets FDA submission requirements

Running Validation

Automatic Validation

Validation runs automatically when you:

• Complete column mapping
• Make changes to mappings
• Prepare for export

Manual Validation

Click Validate in the toolbar or press Ctrl+R (⌘R on macOS).

Validation Results

Result Categories

Results Panel

┌─────────────────────────────────────────────────────────────┐
│ Validation Results                           [✓] [⚠] [ℹ]   │
├─────────────────────────────────────────────────────────────┤
│ ❌ SD0001: USUBJID is required but not mapped               │
│    Rows affected: All                                        │
│    Fix: Map a column to USUBJID                             │
├─────────────────────────────────────────────────────────────┤
│ ⚠️ CT0015: Value "M" not in SEX codelist                    │
│    Rows affected: 45, 67, 89                                │
│    Expected: MALE, FEMALE, UNKNOWN                          │
├─────────────────────────────────────────────────────────────┤
│ ℹ️ INFO: 1250 rows will be exported                         │
└─────────────────────────────────────────────────────────────┘

Validation Rules

Structural Rules

Controlled Terminology Rules

Cross-Domain Rules

Fixing Validation Errors

Mapping Errors

1. Click on the error message
2. The relevant mapping is highlighted
3. Adjust the mapping or source data

Data Errors

1. Note the affected rows
2. Correct the source data
3. Re-import and re-validate

Terminology Errors

1. Review the expected values
2. Map source values to controlled terms
3. Or update source data to use standard terms

Controlled Terminology Validation

Supported Codelists

Trial Submission Studio includes embedded controlled terminology:

• CDISC CT 2025-09-26 (latest)
• CDISC CT 2025-03-28
• CDISC CT 2024-03-29

Codelist Validation

For variables like SEX, RACE, COUNTRY:

• Source values are checked against valid terms
• Invalid values are flagged
• Suggestions for correct values are provided

Validation Reports

Export Validation Report

1. Complete validation
2. File → Export Validation Report
3. Choose format (PDF, HTML, CSV)
4. Save the report

Report Contents

• Summary statistics
• All validation messages
• Affected data rows
• Recommendations

Best Practices

1. Validate early and often - Fix issues as you go
2. Address errors first - Then warnings
3. Document exceptions - If warnings are intentional
4. Keep validation reports - For audit trails

Next Steps

• Exporting Data - Export validated data
• Controlled Terminology - CT reference