An Alternative CDISC-Submission Domain for Laboratory Data (LB) for Use with Electronic Health Record Data

Abstract

Background: The CDISC SDTM standard for submission 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 uncommon. Therefore the current SDTM is not well suited for cases where interoperability between healthcare and research 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 "Laboratory" (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 fullls the requirements for direct population with data from electronic 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.