English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

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.

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