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cdisc.org/odm

ODM (Operational Data Model) certification provides a way for CDISC (Clinical Data Interchange Standards Consortium) to ensure that vendors who support one or more ODM use cases in their software, do so in a manner that complies with the current production version of the ODM Specification

The CDISC ODM is a standard XML based model designed to support interchange and archive clinical trials data.

Versions 164.7.4 and later of CleanWEB are certified for CDISC ODM v.1.3.2. This certification applies to Metadata Import and Export, as well as to Clinical Data Import / Export in snapshot mode.

The official list of certified products is listed on the web site of CDISC, at the following URL http://www.cdisc.org/resources/odm

CleanWEB also implements the CDASH (Clinical Data Acquisition Standards Harmonization) standard. CDASH establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.

Certification Requirements

Modules “EDC” and “Designer” have been audited for the purpose of the CDISC – ODM certification. The two modules include ODM import/export functions for the authorized users:

  • Designer (desktop application) : Metadata Import / Export.
  • EDC (WEB based application) : Metadata and Clinical Data Import / Export in “snapshot” mode.

Metadata Import

ODM certified software provides a metadata import function that allows a sponsor to provide metadata in ODM format to drive study setup activities. The metadata import function must comply with the conformity requirements in the ODM specification.

Metadata Export

ODM certified software provides a metadata export function that allows a sponsor to obtain a copy of the study definition in ODM format. The exported ODM file must comply with the conformity requirements in the ODM Specification, it must validate against the ODM Schema and must accurately reflect the metadata as viewed in the software product.

Clinical Data Import (snapshot mode)

ODM certified software provides a data import function that allows a sponsor to load study data in ODM format into the product. Snapshot mode imports mean that the imported data will not include audit trail or electronic signature information. The clinical data import function must comply with the conformity requirements listed in the ODM Specification.

Clinical Data Export (snapshot mode)

ODM certified software provides a data export function that allows a sponsor to export clinical data from the system in ODM format. A Snapshot mode export will not include audit trail or electronic signature information. The exported ODM file must comply with the ODM Specification, must validate against the ODM Schema and must accurately reflect the data as viewed in the software product.

Documentation

  • CleanWEB : CDISC-ODM Import / Export Module – Technical Specifications (Ref.: CW-189-TEC)
  • CleanWEB : CDISC – ODM Import/Export – User Manual (Ref.: CW-190-USM)
  • Certification report

To obtain documentation or more information, please

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Global Regulatory Requirements

CDISC Standards are now required for regulatory submissions to FDA (U.S.) and PMDA (Japan).
CFDA has endorsed CDISC standards in their Clinical Trial Data Management Technology Guide (July 2016)

Learn more About CDISC