Module 12 Presentations

26/01/2024

FDA Required CDISC Standards:

SDTM ADaM

     

Controlled Terminology

SEND

Define-XML

CDISC Therapeutic Area Standards

The Organisation for Professionals in Regulatory Affairs

9

Other CDISC Models/Initiatives  Operational Data Model ( ODM ) is a vendor neutral and platform independent format, enabling the regulatory-compliant acquisition, archival and interchange of metadata and data for clinical trials.  Protocol Representation Model ( PRM ) is a set of information that is used to describe how protocol elements align. It is called the Domain Analysis Model (DAM), which is a structured framework for capturing data and process requirements around study design, eligibility criteria and study registries. It meets requirements from the ClinicalTrials.gov, WHO registries, and EudraCT registries and helps automate CRF creation and EHR configuration  Clinical Data Acquisition Standards Harmonization ( CDASH ) focuses on standardizing the data acquisition approach, helps ensure traceability of submission data to SDTM. It categorizes data fields into Highly Recommended, Recommended and Optional and is based on 16 standard domains

The Organisation for Professionals in Regulatory Affairs

10

5