CDISC Standards: Explaining SDTM, CDASH, ADaM, ODM-XML, and more

What are CDISC standards?

The map of CDISC standards

Foundational standards

PRM — capturing protocol content

Example of a basic relationship between two classes from the PRM

CDASH — standardizing data collection

CDASH-compliant CRF created in Oracle Health Sciences InForm

SDTM/SEND & SDTMIG/SENDIG — data compilation

Example of variables described in SDTM

ADaM — defining data for analysis

  • describing main principles for creating analysis datasets and metadata
  • describing steps for dataset creation and results generation
  • describing different types of metadata
  • describing dataset content, naming, order of variables, etc.
Analysis results compiled using ADaM principles

Data exchange standards

Structure of CDISC ODM-XML
Design and generation of Linked Clinical Data CubesLaurent Lefort and Hugo Leroux

How to adopt CDISC standards

Level 1: Limited use of CDISC standards

  • Conduct CDISC training
  • Use CDISC PRM in designing CRFs
  • Implement Controlled Terminology
  • Start managing metadata in any format
  • Perform data mapping according to SDTM

Level 2: CDISC standards for regulatory submissions

  • Define and assign data management roles
  • Invest in an electronic data capture (EDC) tool with CDISC support or implement a custom CDISC-compliant solution to your needs
  • Design or build a relational database for eCRFs
  • Adopt Define-XML
  • Implement quality control
  • Implement validation check into your EDC
  • Invest in CDM training or invite data management experts
  • Adopt metrics for commonly requested data
  • Push for enterprise-wide data management

Level 5: Data-driven Business Process enabled by Semantic Technology

Beyond standardization



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