CDISC Data Standards

 What is CDISC?

    Clinical Data Interchange Standards Consortium founded in 1997, is a non-profit data standards organization that develops standards for study planning, collecting, organizing and analyzing data.

PRM:

Protocol Representation Model (PRM) provides a standard for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria, and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries, and EudraCT registries. PRM assists in automating CRF creation and EHR configuration to support clinical research and data sharing.

CDASH:

Clinical Data Acquisition Standards Harmonization establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review. 

SDTM:

Study Data Tabulation Model provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting.

ADaM:

Analysis Data Model defines dataset and metadata standards that support:

• Efficient generation, replication, and review of clinical trial statistical analyses
• Traceability between analysis results, analysis data, and data represented in SDTM.

The ADaM Implementation Guide states: To assist review, ADaM datasets and metadata must clearly communicate how the ADaM datasets were created. The verification of derivations in an ADaM dataset requires having at hand the input data used to create the ADaM dataset. A CDISC-conformant submission includes both SDTM and ADaM datasets; therefore, it follows that the relationship between SDTM and ADaM must be clear. This requirement highlights the importance of traceability between the analyzed data (ADaM) and its input data (SDTM).

Traceability is built by clearly establishing the path between an element and its immediate predecessor. The full path is traced by going from one element to its predecessors, then on to their predecessors, and so on, back to the SDTM datasets, and ultimately to the data collection instrument.

ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

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