The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and related areas of healthcare". The standards support medical research from protocol through analysis and reporting of results and 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]Since December 2016, CDISC standards are mandatory for submission to US FDA.[2][3]
CDISC standards are harmonized through a model that is also a HL7 standard and is the process to becoming an ISO/CEN standard.
Recommended for FDA regulatory submissions since 2004.
The SDTM Implementation Guide (SDTM-IG) gives a standardized, predefined collection of domains for clinical data submission, each of which is based on the structure and metadata defined by the SDTM.
The SEND Implementation Guide (SEND-IG) provides predefined domains and examples of non-clinical (animal) data based on the structure and metadata defined by the SDTM.
Analysis Data Model (ADaM)
Defines dataset and metadata standards that support statistical analyses and traceability. ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).
The highlights of ODM: includes an audit trail, utilizes XML technology, machine- and human-readable, all information are independent of databases, storing of ODM is independent of hard- and software.
Laboratory Data Model (LAB)
The Lab standard is used for the exchange of laboratory data between labs and CROs
Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf".
Clinical Data Acquisition Standards Harmonization (CDASH)[6]
Defines a minimal data collection set for sixteen safety SDTM Domains, harmonizing element names, definitions and metadata. The objective is to establish a standardized data collection baseline across all submissions.
CDISC Terminology
Defines controlled terminology for SDTM and CDASH, provides extensible lists of controlled terms designed to harmonize data collected across submissions.
The CDISC Operational Data Model[7] (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.[8]
ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012.[9] 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 a number of constructs for modelling electronic Case Report Forms (CRFs). ODM is often combined with the 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.
The ODM schema is generally divided into three categories of data: Metadata, Admin data, and Clinical data. Metadata describes the structure of the eCRFs within the study, and how they relate to scheduled visits. Admin data contains references to users, locations, and any additional non-structural and non-clinical reference data. Clinical data contains all eCRF item values and references both Metadata and Admin data.[10]
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 CDISCSDTM, SEND or ADaM[11] format to regulatory authorities. The key metadata components to support submissions are:
Dataset definition
Dataset variable definitions
Controlled Terminology definitions
Value list definitions
Links to supporting documents
Computational method definitions
Comments definitions
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 on the CDISC website.
Clinical Trial Representation allows representing basic characteristics of a clinical trial, such as study sponsor, study name, size of the trial (number of participants). The standard was first introduced in 2016.
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.
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, the relationship among data elements, properties in a relationship, and controlled terminologies) relevant to clinical studies more efficiently and consistently. With all this 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 maintains a list of solutions providers, subject matter experts and consultants deemed to have sufficient knowledge and experience implementing the various CDISC standards.
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.
Full import allows importing of ODM-formatted clinical data (Metadata and Data). This is useful for setting up the EDC system to capture data. It 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.
The EDC system will generate ODM data files for further processing. For example, REDCap Cloud data capture systems to allow export of a study in ODM.[12]
