LOINC codes and ryze

both cdisc controlled terms and loinc code provide a mechanism for identifying lab data, however the loinc code is not a “human readable” identifier, it is just a code number, whereas the cdisc controlled terms used in lbtestcd, lbtest, lbmethod etc are human readable, descriptive text, e g loinc 2955 3 vs “c64809” sodium sodium , urine loinc can be used to organise the data from labs, however the data collected from local labs may not match cdisc standards or may change depending on site or source some labs may provide a loinc code and some may not loinc codes historically have not been required for an fda submission, however from 15th march 2020, new drug applications (ndas), abbreviated new drug applications (andas), and certain biological license applications (blas) will require loinc coding a helpful guide is available from cdisc, see https //www cdisc org/kb/articles/loinc and sdtm cdisc also provides a lookup table for converting loinc codes to cdisc/nci sdtm controlled terms the following steps describe how to translate loinc code to cdisc sdtm take the raw data from the local lab and assign a loinc code if the local lab test is missing some of the details to classify as a specific loinc code, you can assign a more generic loinc code e g if the local lab fails to record if a sample is serum, plasma or whole blood, use the more generic loinc test for blood by assigning a loinc code you can then use the cdisc lookup table the loinc code can be assigned at the local lab or at a central lab some labs may assign their own loinc code use the cdisc loinc lookup table to find the cdisc code 3\ build your datasets in ryze, for example by importing the sdtm assets (such as the labs dataset) found in the cdisc code lookup table if it is not assigned by the local lab, remove the loinc code if you assign loinc code at a central lab, it may not be considered accurate you can then use the cdisc lookup table to assign the applicable sdtm variables, units, terminology etc in ryze then it is accurate for submission using this method makes the process of assignment of lab identifiers (such as lbtest, lbtestcd, lbspec, lbmethod) consistent across all lab sources and avoids misassigning local lab data vs central lab data mapping loinc to the cdisc/nci c code, then translating from c code to sdtm submission text, allows the process to adapt to different cdisc/nci versions where the sdtm submission text may change for a given term it also allows you to change things like nci terminology with version changes and it'll work across all the lab data