Controlled Terminology
CDISC Controlled Terminology (CT) provides standardized values for SDTM variables.
Overview
Controlled Terminology ensures:
- Consistency across studies and organizations
- Interoperability between systems
- Regulatory compliance with FDA requirements
Embedded CT Packages
Trial Submission Studio includes the following CT versions:
| Version | Release Date | Status |
|---|---|---|
| 2024-12-20 | December 2024 | Current |
| 2024-09-27 | September 2024 | Supported |
| 2024-06-28 | June 2024 | Supported |
Common Codelists
SEX (C66731)
| Code | Decoded Value |
|---|---|
| M | MALE |
| F | FEMALE |
| U | UNKNOWN |
| UNDIFFERENTIATED | UNDIFFERENTIATED |
RACE (C74457)
| Decoded Value |
|---|
| AMERICAN INDIAN OR ALASKA NATIVE |
| ASIAN |
| BLACK OR AFRICAN AMERICAN |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
| WHITE |
| MULTIPLE |
| NOT REPORTED |
| UNKNOWN |
ETHNIC (C66790)
| Decoded Value |
|---|
| HISPANIC OR LATINO |
| NOT HISPANIC OR LATINO |
| NOT REPORTED |
| UNKNOWN |
COUNTRY (C66729)
ISO 3166-1 alpha-3 country codes:
- USA, CAN, GBR, DEU, FRA, JPN, etc.
AESEV (C66769) - Severity
| Decoded Value |
|---|
| MILD |
| MODERATE |
| SEVERE |
AESER (C66742) - Serious
| Code | Decoded Value |
|---|---|
| Y | Y |
| N | N |
NY (C66742) - No Yes Response
| Code | Decoded Value |
|---|---|
| Y | Y |
| N | N |
VSTESTCD (C66741) - Vital Signs Test Codes
| Code | Decoded Value |
|---|---|
| BMI | Body Mass Index |
| DIABP | Diastolic Blood Pressure |
| HEIGHT | Height |
| HR | Heart Rate |
| PULSE | Pulse Rate |
| RESP | Respiratory Rate |
| SYSBP | Systolic Blood Pressure |
| TEMP | Temperature |
| WEIGHT | Weight |
LBTESTCD - Lab Test Codes
Common examples:
| Code | Description |
|---|---|
| ALB | Albumin |
| ALT | Alanine Aminotransferase |
| AST | Aspartate Aminotransferase |
| BILI | Bilirubin |
| BUN | Blood Urea Nitrogen |
| CREAT | Creatinine |
| GLUC | Glucose |
| HGB | Hemoglobin |
| PLAT | Platelet Count |
| WBC | White Blood Cell Count |
Extensible vs Non-Extensible
Non-Extensible Codelists
Values must exactly match the codelist:
- SEX
- COUNTRY
- Unit codelists
Extensible Codelists
Additional values allowed with sponsor definition:
- RACE (can add study-specific values)
- Some test codes
Using CT in Trial Submission Studio
Automatic Validation
When you map variables with controlled terminology:
- Values are checked against the codelist
- Non-matching values are flagged
- Suggestions are provided
Value Mapping
For source values not in CT format:
- Create value-level mappings
- Map “Male” → “M”, “Female” → “F”
- Apply consistently
CT Version Selection
- Go to Settings → Controlled Terminology
- Select the appropriate CT version
- Validation uses selected version
Handling CT Errors
Value Not in Codelist
Error: “Value ‘XYZ’ not found in codelist”
Solutions:
- Check spelling/case
- Find the correct CT value
- Map source value to CT value
- For extensible codelists, document new value
Common Mappings
| Source Value | CT Value |
|---|---|
| Male | M |
| Female | F |
| Yes | Y |
| No | N |
| Caucasian | WHITE |
| African American | BLACK OR AFRICAN AMERICAN |
Updating CT
New CT versions are released quarterly by CDISC. To use newer versions:
- Check for Trial Submission Studio updates
- New CT is included in app updates
- Select version in settings
Resources
Official References
Next Steps
- SDTM Variables - Variables requiring CT
- Validation - CT validation in practice