CDISC

About CDISC

The Clinical Data Interchange Standards Consortium, known as CDISC, is a 501(c)(3) global, nonprofit charitable organization that develops data standards to streamline clinical research and enable connections to healthcare. The official CDISC website is loaded with information to support various needs and interests. Though not an exhaustive list of interests, we find most ClinSpark users:

• are new to CDISC and want to learn more

• want to learn the ODM used to build ClinSpark

• want to increase knowledge of foundational standards, especially SDTM

• want to verify Foundry Health’s membership

• want to share use of clinical research data

ODM

The CDISC Operational Data Model (ODM) is a vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information. ODM-XML facilitates the regulatory-compliant acquisition, archival and exchange of metadata and data. It has become the language of choice for representing case report form (CRF) content in many electronic data capture (EDC) tools.

The latest information on the ODM can be viewed on the CDISC website.

SDTM

The CDISC Study Data Tabulation Model (SDTM) is a way to organize and format the data collected in a clinical trial.  Data is organized into groupings called Domains. Domains contain data for topics like Demographic data or Adverse Events.

The SDTM Implementation Guide contains standardized domains.

• Domains have a fixed set of of allowed variables

• Variables have standard names and labels, standard data types, formats and other attributes

• Some variables are populated using standard lists of values

• Many of the Questions (e.g. test names) are standardized