Note: one LOINC code maps to many CDISC variables
Using LOINC in Clinical Research
- LOINC codes are NOT required by CDISC standards
- LOINC codes ARE required by some regulators for regulatory submissions (e.g., US FDA as of Mar 2020)
- LOINC codes ARE required in some countries for healthcare IT systems
Use LOINC codes supplied by the analytical lab where applicable and available.
The US FDA recognizes that not all tests have LOINC terms. For those that don’t, or where analysis is done by small specialty labs that do not have the facility to provide them, the codes may be omitted and explained in the SDRG, but the FDA does expect that some effort be made to obtain them.
US FDA/CDISC/Regenstrief/NIH LOINC Working Group is addressing implementation concerns and has published recommendations for submission of LOINC codes.
The US FDA Standards Website states that “…The FDA plans to review the Working Group document and provide recommendations in the Study Data Technical Conformance Guide.”
CDISC SDTM findings domains can use the standard variable LOINC.
CDISC is preparing mappings of common LOINC codes to SDTMIG variable values
Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the U.S. Food and Drug Administration, November 2018
LOINC Getting Started Guide
LOINC Overview Video
LOINC and RELMA Workshops
LOINC Essentials eBook - Covers the basics of LOINC and specific mapping strategies: