Background: The CDISC SDTM standard for submis- sion of clinical study data to the FDA was developed at a time when the extraction of data from electronic health records or hospital information systems was still uncom- mon. Therefore the current SDTM is not well suited for cases where interoperability between healthcare and re- search has already been realized.
Objectives: It is therefore necessary to adapt the SDTM to accommodate for these present-day use cases.
Methods: A critical analysis of the existing "Labora- tory" (LB) SDTM domain has been made with respect to the suitability to represent data extracted from electronic health records.
Results: An alternative "Laboratory" domain (abbreviated LN Laboratory New) for usage with data from electronic health records is presented.
Conclusions: The alternative LN domain presented ful lls the requirements for direct population with data from elec- tronic health records. As a by-product, it allows reviewers at the FDA to actually compare laboratory data between studies and submissions which was not possible with the classic SDTM "Laboratory" domain.