The Study Data Tabulation Model (SDTM) is a specification for the submission of pre-clinical and

Define-XML files are an essential component of a CDISC data submission to the US FDA.  In the

This course will cover the differences between SDTM standard versions v1.4 to v1.7 and SDTM

The ADaM Theory and Application training is a deep dive into the ADaM standard and should orient

This course covers the CDASH Model v1.0, the CDASH Implementation Guide v2.0, and relevant

Therapeutic Area User Guide, Module 21 provides an understanding of the Prostate Cancer indication,

Define-XML Module Two presents business purpose and technical implementation details for SDTM, SEND

The Analysis Data Model (ADaM) specifies principles for analysis datasets and standards for a

ADaM Module Seven describes key BDS elements that support traceability in data analysis and

The Analysis Data Model (ADaM) specifies principles for analysis datasets and standards for a

Controlled Terminology Module Two provides an overview of the different file formats in which CT is