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 Plus monthly

Global: Zendy Tools annual

Global: Zendy Tools monthly

Global: Zendy Free Plan

Data standards are now required for many submissions to the United States Food and Drug Administration (FDA). The required standard for submission of clinical data is the Clinical Data Interchange Standards Consortium (CDISC) Submission Data Tabulation Model (SDTM). Currently, 45 business rules and 115 associated validation rules exist for SDTM data. However, such rules have not yet been developed for therapeutic area data standards developed under the last reauthorization of the Prescription Drug User Fee Act (PDUFA V). The objective of this effort was to develop data validation rules for new therapeutic area data standards in four mental health domains, assess the metadata required to associate such rules with standard data elements, and assess the level of data validation possible for therapeutic area data elements.

studies in health technology and informatics

Development of Data Validation Rules for Therapeutic Area Standard Data Elements in Four Mental Health Domains to Improve the Quality of FDA Submissions.