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ODM Certification

 

 

 

New Pricing effective April 2014 for 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 is currently partnering with Next Step Clinical Systems to provide ODM Certification.

 

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 Information for Companies with Products to be Certified:

  • Your organization/company must be a CDISC member in good standing
  • 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 – for the current fee schedule see 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 and keep your annual renewal fees current to maintain your listing in the ODM Certification table on the CDISC web site
  • For complete program information, reference CDISC Operating Procedure (COP) 002.

 

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 includes:

An initial assessment (up to 8 hours) and up to 5 additional days (40 hours) 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. Reference COP 002 for complete ODM certification program information.

 

- Annual Renewal to maintain listing

 

 

  • The Initial Fee includes up to 5 days for an ODM Expert to perform the certification, documentation of the certification in a final report, inclusion of the vendor’s name and certified product(s) in the ODM Certified Product listing, inclusion in the CDISC Registered Solutions Provider list for ODM and all the advertising CDISC does on behalf of the ODM Certified Products.
  • The Annual Renewal fee is to maintain the listings in CDISC ODM Certified Products and Registered Solutions Provider lists.
  • The Update Fee applies when a vendor wishes to have their product certified against another version of ODM or there is a new version of a certified product that needs re-certification. CDISC will charge time, materials and any travel necessary to complete the certification assuming the vendor has maintained CDISC membership and ODM Certification Annual Fees.

 

CLICK HERE to apply for ODM Certification.

 

The current list of ODM Certified products:

ODM Data Import ODM Data Export
Snapshot Transactional Snapshot Transactional
MetadataData MetadataData MetadataData MetadataData
BioClinica
http://www.bioclinica.com/
BioClinica Express & BioClinica Export Utility
Version: Version 4.1
Date of Certification: 06.07.09
ODM Version: V1.2
CTEP Limited
http://www.realworldedc.com/
Core Tailor
Version: V1.1.2
Date of Certification: 10.23.10
ODM Version: V1.3
eResearch Technology
Expert ODB
Version: 6.4.1.10
Date of Certification: 06.20.11
ODM Version:
The EMMES Corporation
http://www.emmes.com/
AdvantageEDC
Version: 20 (ODM Data Download v1.0)
Date of Certification: 09.20.11
ODM Version: V1.3
Flexcipio SA
http://www.flexcipio.com/
eClinical Platform
Version: Version 1.1
Date of Certification: 11.17.08
ODM Version: V1.3
Formedix
http://www.formedix.com/
Origin Study Modeller
Version: 2.8.4
Date of Certification: 10.19.09
ODM Version: V1.3
Mebix, Inc.
http://www.mebix.co.jp/
CapTool Prime
Version: 1.0.4
Date of Certification: 07.02.10
ODM Version: 1.3
Medidata Solutions
http://www.mdsol.com/
Medidata Designer
Version: V2.5
Date of Certification: 09.26.07
ODM Version: V1.2 (V1.2.1)
Medidata Solutions
http://www.mdsol.com/
Medidata Rave
Version: 5.6.2
Date of Certification: 04.16.08
ODM Version: V1.2 & V1.2.1
MedNet Solutions
http://www.mednetstudy.com/
ENLIGHTEN
Version: ODM Export Utility V1.1
Date of Certification: 11.21.09
ODM Version: 1.3
OmniComm Systems
http://www.omnicomm.com/1Home/index.asp
eClinical Data Capture (EDC)
Version: 5.0.0.1
Date of Certification: 02.11.08
ODM Version: V1.3
Oracle Corporation
http://www.phaseforward.com/
Central Designer
Version: Version 1.2 SPO
Date of Certification: 10.21.08
ODM Version: V1.3
Oracle Corporation
http://www.phaseforward.com/
Inform Adapter
Version: Version 1.2 SP3
Date of Certification: 10.21.08
ODM Version: V1.3
Perceptive Informatics, Inc.
http://www.perceptive.com/
DataLabs Clinical
Version: V4.1.2.1 Build 11300
Date of Certification: 07.06.07
ODM Version: V1.2
PHT
http://www.phtcorp.com/
StudyWorks
Version: 4.9.5
Date of Certification: 05.27.08
ODM Version: V1.2 & V1.2.1
XClinical
http://www.xclinical.com/
MARVIN
Version: V1.7.7
Date of Certification: 06.12.07
ODM Version: V1.2 (V1.2.1)
XML 4 Pharma
http://www.xml4pharma.com/
ODMDesigner
Version: 2008 R1
Date of Certification: 06.11.08
ODM Version: V1.2, V1.2.1 & V1.3