CDISC ODM Certification

13-Mar-2013 - CDISC announces the Re-Launch of the ODM Certification Program!

CLICK HERE to apply for ODM Certification.

CDISC began the ODM Certification program in 2007 with the intent of providing the industry, the CDISC user community and companies offering ODM-capable products, the assurance that ODM files have a high level of conformity to the published specifications. CDISC announces the re-launch of the ODM Certification Program with our new partner - Next Step Clinical Systems. The CDISC ODM Certification uses a suite of updated certification tools, developed by Next Step Clinical Systems, which are capable of testing products against the latest ODM version requirements.

Benefits of ODM Certification for the CDISC User Community:

• Assurance that the products you implement have been tested and are compliant with the CDISC Operational Data Model such that certified tools will be able to seamlessly exchange data in a common format.
• The opportunity to ‘plug and play’ with tools that are ODM Compliant, providing more choice in applications for research data collection and exchange.
• Additional benefits of products that use ODM, including archive of data in a manner that is readily retrievable without the specific system that captured the data, support for CDASH such that data can be readily formatted into SDTM for eSubmissions and generally saving time and resources in clinical research through the use of CDISC data standards.

Benefits of ODM Certification for Organizations with ODM-capable Products:

• Acknowledgement and advertising through CDISC to the industry that the product(s) you provide meets compliance criteria for the ODM version specified
• Listing by CDISC of your certified product(s) on our web site, to be displayed in a more prominent manner
• Announcements by CDISC in the eNewsletter and social media blasts to describe products that have achieved ODM certification
• Publicity of ODM certified products at CDISC events and events CDISC attends (e.g. on posters and in conference programs) 
• Automatic listing of your company/organization on the Registered Solutions Provider list for ODM

Program Requirements for Companies with Products to be Certified:

• Your organization/company must be a CDISC member
• There will be an initial fee for the certification process and listing of your company and product(s) as well as an annual renewal fee based on the size of your organization /company and level of CDISC membership – see chart below.
• After your product has passed the certification process and all invoices are paid CDISC will post the results in the ODM Certification table on our web site
• The version(s) of your product(s) will be listed with the ODM component(s) and version(s) they are certified against
• You must remain a CDISC member in good standing to maintain your listing in the ODM Certification table on the CDISC web site

NOTICES:

CDISC reserves the right to remove any product from the list that is found to be non-compliant. CDISC is making the information available in the ODM Certification list as a service with the assurance that the listed version of a product has been certified to have the identified ODM capabilities. CDISC makes no assurance regarding other versions of the product with any of the ODM versions unless those other product versions have been specifically tested through the ODM Certification Process against any of the ODM versions

The ODM Certification process covers 7 use cases:

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 final report

Pricing for the ODM Certification Program has 2 components:

Initial Fee includes up to 5 days to perform the certification (including preliminary assessment), a final report, inclusion of your company in the ODM Certified Product listing, inclusion in the CDISC Registered Solution Provider List for ODM (normally an additional fee) and all the advertising CDISC does on behalf of the ODM Certified Products.

- Annual Renewal to maintain listing

CLICK HERE to apply for ODM Certification.

The current list of ODM Certified products: