1. CDISC Use of LOINC Codes

2. LOINC Code Definition Component Property Time System Scale Method
Analyte: Sodium, IgG, HIV-1 Antibody
Property
Defines the nature of the UOM
Examples: Mass Concentration (mg/dL), Count, Time
Time
Time span of test: Point in Time, 24 Hour Clearance
System
Specimen type: Whole Blood, Serum, Urine
Scale
Nature of the result value: Qualitative, Ordinal, Quantitative
Method
Test Method: Ion Selective Electrode (ISE), Dip Stick, Methodless

3. Example LOINC Codes Component Property Time System Scale Method
Glucose
MCNC PT
SER QN
SCNC
Creatinine UR
Creatinine Clearance
SRAT
24H
HIV1 Antibody
ACNC
ORD
EIA IB

4. CDISC Strengths Post Coordinated Codes (CDISC)
Separate fields for each concept
Much better fit for Data Warehouses, Statistical Analysis, Informatics, Data Mining etc.
Pre-Coordinated Codes (LOINC)
Single Code includes multiple concepts
Much better fit for real time, machine to machine messaging

5. CDISC Issues with LOINC
Property
SI vs. Conventional may be different codes (e.g. glucose mg/dL vs mmol/L)
Methods
Does CDISC FDA want method specific vs. methodless codes.
Does performing lab (LBNAM) really override method?
Time Draws
Does CDISC/FDA want time draw specific codes for true challenge tests (e.g. post-dose glucose)?

6. Why/How to Use LOINC What is the business driver to use LOINC Codes?
Should LOINC codes be in the transmission model, or as metadata in SHARE?
If we do LOINC codes (US based), why not SNOMED (EU, Canada, Australia based)?