CDISC

CDISC ODM Certification Service

Click here to apply for CDISC ODM Certification

CDISC logoNext Step Clinical Systems offers ODM Certification services on behalf of CDISC. The CDISC Operational Data Model (ODM) provides a platform independent, vendor neutral XML standard for clinical trials study data interchange and archive. Since it was introduced in 2001, use of the ODM has become increasingly important for organizations using CDISC standards as the basis of their clinical research systems.

To maximize the value of the ODM for the organizations that implement it, CDISC offers a certification service. The service is provided to software vendors who provide software products or services for reading and writing ODM XML documents and who want to assure their customers that

  • ODM documents produced by their products comply with the requirements of the ODM Specification.
  • Software products that allow ODM documents as input, use the information provided in the ODM as intended by the ODM Specification.

The ODM Certification process covers 7 use cases:

ODM Certification Use Cases
Metadata Export
Metadata Import
Metadata Interoperability – Metadata Import and Export are pre-requisites
Snapshot Clinical Data Export – Metadata export is a pre-requisite
Transactional Clinical Data Export – Metadata export is a pre-requisite
Snapshot Clinical Data Import – Metadata import is a pre-requisite
Transactional Clinical Data Import – Metadata import is a pre-requisite

The certification process flow includes:

  • Preliminary assessment
  • Conformity testing of ODM files produced by vendors’ software
  • Product testing using ODM documents designed to exercise ODM features
  • Product documentation review
  • Certification report

For more information about the Next Step Clinical Systems’ CDISC ODM Certification Service, contact us at Info@nextstepclinicalsystems.com.

For information about pricing of ODM Certification see CDISC ODM Certification.