SDTM Validation Rules

Trial Submission Studio validates data against SDTM implementation guide rules.

Validation Categories

Structural Validation

Checks data structure and format.

Content Validation

Checks data values and relationships.

Cross-Record Validation

Checks relationships between records.

Common Validation Rules

Identifier Rules

STUDYID

• Must be present in all records
• Must be consistent across domains
• Cannot be null or empty

USUBJID

• Must be present in all records
• Must exist in DM domain
• Must be unique per subject

DOMAIN

• Must match the domain abbreviation
• Must be uppercase
• Must be 2 characters

Date/Time Rules

–DTC Variables

• Must follow ISO 8601 format
• Supported formats:
  • YYYY-MM-DDTHH:MM:SS
  • YYYY-MM-DD
  • YYYY-MM
  • YYYY

Date Ranges

• End date cannot precede start date
• Study dates should be within study period

Controlled Terminology Rules

SEX

Valid values:

• M (Male)
• F (Female)
• U (Unknown)
• UNDIFFERENTIATED

AESEV

Valid values:

• MILD
• MODERATE
• SEVERE

AESER

Valid values:

• Y (Yes)
• N (No)

Validation Report

Error Summary

┌─────────────────────────────────────────────────────────────┐
│ Validation Summary                                          │
├─────────────────────────────────────────────────────────────┤
│ Errors:   5                                                 │
│ Warnings: 12                                                │
│ Info:     3                                                 │
├─────────────────────────────────────────────────────────────┤
│ Domain: DM                                                  │
│   - 2 Errors                                                │
│   - 3 Warnings                                              │
│                                                             │
│ Domain: AE                                                  │
│   - 3 Errors                                                │
│   - 9 Warnings                                              │
└─────────────────────────────────────────────────────────────┘

Error Details

Each error includes:

• Rule ID: Unique identifier
• Severity: Error/Warning/Info
• Description: What’s wrong
• Location: Affected rows/columns
• Suggestion: How to fix

Fixing Validation Issues

Mapping Issues

1. Verify correct source column is mapped
2. Check data type compatibility
3. Ensure all required variables are mapped

Data Issues

1. Review affected rows
2. Correct values in source data
3. Re-import and re-validate

Terminology Issues

1. Check expected values in codelist
2. Map source values to standard terms
3. Use value-level mapping if needed

Custom Validation

Severity Overrides

Some warnings can be suppressed if intentional:

1. Review the warning
2. Document the reason
3. Mark as reviewed (if applicable)

Adding Context

For validation reports:

• Add comments explaining exceptions
• Document data collection differences
• Note protocol-specific variations

Best Practices

1. Validate incrementally

   • After initial mapping
   • After each significant change
   • Before final export

2. Address errors first

   • Errors block export
   • Warnings should be reviewed
   • Info messages are FYI

3. Document exceptions

   • Why a warning is acceptable
   • Protocol-specific reasons
   • Historical data limitations

4. Review validation reports

   • Keep for audit trail
   • Share with data management
   • Include in submission package

Next Steps

• Controlled Terminology - Valid values
• Exporting Data - Export after validation