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Transport Standards

 

CDISC Transport Standards enable the exchange of data conformant with CDISC Foundational Standards and their Therapeutic Area extensions.

Clinical Trial Registry (CTR)-XML lets technology vendors implement tools that support a "write once, use many times" solution based on a single XML file that holds the information needed to generate submissions for multiple clinical trials for clinical trial registry submissions primarily to the World Health Organization (WHO), European Medicines Agency (EMA) EudraCT Registry and United States ClinicalTrials.gov.

Operational Data Model (ODM)-XML 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 content in many electronic data capture (EDC) tools. ​

Study/Trial Design Model in XML (SDM-XML) is an extension of ODM-XML and allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies, including treatment plans, eligibility and times and events. SDM-XML defines three key sub-modules – Structure, Workflow, and Timing – permitting various levels of detail in any representation of a clinical study’s design.

Define-XML** transmits metadata that describes any tabular dataset structure. When used with the CDISC Foundational standards, it provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM. Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.

Dataset-XML supports the exchange of dataset data based on Define-XML metadata. Dataset-XML complements Define-XML and provides an alternative to the SAS V5 Transport format for the exchange of study datasets for CDISC's Foundational standards. Dataset-XML is a truly non-proprietary, global standard, removing many SAS V5 Transport file restrictions (the current file format required by the FDA and PMDA), such as 8-character variable names and 200-character text fields.

CDISC Standards in RDF provides a representation of the CDISC Foundational standards in a model based on the Resource Description Framework (RDF). RDF provides executable, machine-readable CDISC standards from CDISC SHARE. This file format is a “linked data” view of the standards as an ontology.

The Laboratory Data Model (LAB) provides a standard model for the acquisition and exchange of laboratory data, primarily between labs and sponsors or CROs. The LAB standard was specifically designed for the interchange of lab data acquired in clinical trials.

**Required by the FDA and PMDA (Japan) for new drug submissions