Clinical Data Interchange Standards Consortium

The Clinical Data Interchange Standards Consortium (CDISC) is an open, multidisciplinary, neutral, 501(c)(3) non-profit standards developing organization (SDO) that has been working through productive, consensus-based collaborative teams, since its formation in 1997, to develop global standards and innovations to streamline medical research and ensure a link with healthcare. The CDISC mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare". The CDISC Vision is "informing patient care and safety through higher quality medical research". The CDISC suite of standards supports medical research of any type from protocol through analysis and reporting of results. They have been shown to decrease resources needed by 60% overall and 70-90% in the start-up stages when they are implemented at the beginning of the research process).[1]

They are harmonized through a model that is now not only a CDISC standard but also an HL7 standard on the path to becoming an ISO/CEN standard, thus giving the CDISC standards (harmonized together through BRIDG) international status and accreditation.

CDISC History

Overview of CDISC standards

Individual CDISC standards

Operational Data Model (ODM)

The CDISC Operational Data Model (ODM) is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data for clinical research studies. ODM is a vendor neutral, platform independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information.[3] ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012.[4] ODM extensions have been developed to create a number of additional CDISC standards, including Define-XML, Dataset-XML, SDM-XML, and CTR-XML and future planned standard Protocol-XML.

ODM is an XML based standard and it is an XML schema that provides number of constructs for modeling electronic Case Report Forms (CRFs). ODM is often combined with Study Data Model standard to more fully model trial arms or trial activities. ODM is also used in sending forms data from a clinical trial system to an Electronic Health Record (EHR) system.

Define-XML

Define-XML supports the interchange of dataset metadata for clinical research applications in a machine-readable format. An important use case for Define-XML is to support the submission of clinical trials data in CDISC SDTM, SEND or ADaM format to regulatory authorities. The key metadata components to support submissions are:

Define-XML can also be used to describe proprietary, non-CDISC dataset structures. The Define-XML model is implemented using extensions to the CDISC Operational Data Model (ODM) XML schema. The current version is 2.0 published in

BRIDG

CDISC BRIDG model is a unifying model of the domain of clinical research and research studies. It defines basic elements such as investigator, subject, study, intervention. It is used to keep all standards consistent. It was first introduced in 2006 with version 2 released in 2008. It can be obtained as UML model as well as .OWL format.

SHARE

CDISC SHARE (Shared Health and Clinical Research Electronic Library) is a metadata repository that supports the development, governance, publishing, and consumption of CDISC standards in human and machine-readable formats. SHARE helps users find, understand, and use rich metadata (i.e., research concepts, data elements and attributes, relationship among data elements, properties in relationship, and controlled terminologies) relevant to clinical studies more efficiently and consistently. With all these information in a single repository, SHARE will improve integration and traceability of clinical data end-to-end, from protocol through analysis. SHARE will provide a collaborative standards development environment that will improve quality, integration, and consistency across CDISC standards.

CDISC registered solutions providers

CDISC maintains a list of solutions providers, subject matter experts and consultants deemed to have sufficient knowledge and experience implementing the various CDISC standards.

ODM and EDC integration

Electronic Data Capture (EDC) systems can be certified as compliant with the Operational Data Model (ODM) by CDISC. There are two main types of integration, ODM Import and ODM Export.

ODM Import

Full import allows importing of ODM-formatted clinical data (MetaData and Data). MetaData only import allows only the importing of MetaData. This is useful for setting up the EDC system to capture data. Basically allows third party software to define the forms, variables etc. used in the EDC system. This provides an EDC vendor-neutral system for defining a study.

ODM Export

The EDC system will generate ODM data files for further processing.

See also

Further reading

References

  1. ↑ "Andrea Vadakin: CDISC standards and innovations, 2012" (PDF).
  2. ↑ "Dataset".
  3. ↑ Huser, V; Sastry, C; Breymaier, M; Idriss, A; Cimino, J. J. (2015). "Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)". Journal of Biomedical Informatics 57: 88–99. doi:10.1016/j.jbi.2015.06.023. PMID 26188274.
  4. ↑ "ODM".

External links

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