Clinical Data Interchange Standards Consortium
The Clinical Data Interchange Standards Consortium is a standards developing organization (SDO) dealing with medical research data linked with healthcare, made to enable information system interoperability and 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. Since December 2016, CDISC standards are mandatory for submission to US FDA.
CDISC standards are harmonized through a model that is also a HL7 standard and is the process to becoming an ISO/CEN standard.
History
- Late 1997 – Started as a Volunteer group
- Summer 1998 – Invited to form DIA SIAC
- 1999 – SDS v1.0; ODM v0.8
- 2000 – SDS v1.1
- Feb 2000 – Formed an Independent, non-profit organization
- Dec 2001 – Global participation
- 2001 – SDS v2.0; ODM v1.0
- 2002 – ODM v1.1; ADAM v1.0
- 2003 – LAB v1.0; SDTM v1/SDTM-IG v3.0; BRIDG Model Initiated; SEND 1.0
- 2004 – LAB v1.1; ODM v1.2; SDTM v3.1
- 2005 – Define.xml Implementation; Release ; SEND v.2; ODM v1.2.1; SDTM v1.1/SDTMIG v3.1.1; ODM mapped to HL7 RIM
- 2006 – BRIDG v1.0, v1.1; BRIDG posted as open-source model
- 2007 – ODM v1.3; LAB & SDTM Aligned; BRIDG posted as open-source model
- 2008 – BRIDG v2.0, v2.1, v2.2; CDASH v1.0; ESDI document published
- 2009 – SDTM v1.2/SDTMIG 3.1.2; ADAM v2.1 and ADAMIG v1.0; Imaging CRFs; CDISC-IHE RFD and RPE
- 2010 – Protocol Representation Model; v1.0; BRIDG v3.0; ODM v1.3.1; HHS-ONC/HITSP Interoperability Specification #158; CDISC-IHE RPE
- 2011 – CDASH v1.1; SEND v3.0; Study Design XML v1.0, ADAM Examples in Commonly Used Statistical Analysis Methods v1.0
- 2012 – The ADAM Basic Data Structure for Time-to-Event Analyses v1.0, ADAM Data Structure for Adverse Event Analysis v1.0
- 2013 – Define-XML Version 2.0, SDTM v1.4/SDTMIG v3.2
- 2014 – SHARE R1
- 2015 – ARM v1.0 extension for Define-XML Version 2
- 2016 – Dataset XML, Therapeutic Areas, CTR-XML, ADAMIG v1.1, ADM OCCDS v1.0
Overview of standards
- Dataset.XML
- * Enables communication of study results as well as regulatory submission to FDA.
- Study Data Tabulation Model
- * Recommended for FDA regulatory submissions since 2004.
- * The SDTM Implementation Guide 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.
- Standard for Exchange of Non-clinical Data (SEND)
- * The SEND Implementation Guide provides predefined domains and examples of non-clinical data based on the structure and metadata defined by the SDTM.
- Analysis Data Model
- * Defines dataset and metadata standards that support statistical analyses and traceability. ADaM is one of the required standards for data submission to FDA and PMDA.
- Operational Data Model (ODM)
- * 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
- * The Lab standard is used for the exchange of laboratory data between labs and CROs
- Case Report Tabulation Data Definition Specification
- * Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf".
- Clinical Data Acquisition Standards Harmonization
- * 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.
Individual standards
Operational Data Model (ODM)
The CDISC Operational Data Model 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.ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. 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. 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 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.
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:- Dataset definition
- Dataset variable definitions
- Controlled Terminology definitions
- Value list definitions
- Links to supporting documents
- Computational method definitions
- Comments definitions