The CDISC Operational Data Model (ODM) Certification program exists to provide assurance that your ODM-capable products are able to produce ODM files with a high level of conformity to the published specifications.
The ODM Certification process covers seven use cases:
ODM Certification Use Cases |
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Metadata Export
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Metadata Import
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Metadata Interoperability - Metadata import and export are pre-requisites
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Snapshot Clinical Data Export - Metadata export is a pre-requisite
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Transactional Clinical Data Export - Metadata export is a pre-requisite
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Snapshot Clinical Data Import - Metadata import is a pre-requisite
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Transactional Clinical Data Import - Metadata import is a pre-requisite
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The ODM certification process includes:
- A preliminary assessment (up to 8 hours)
- Performance of certification (up to 40 hours), including:
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- Conformity testing of ODM files generated by your company’s software
- Product testing using ODM documents designed to exercise ODM features
- Product documentation review
- Final certification report
Benefits
The benefits of obtaining ODM Certification for your products include:
- The perpetual right to use the CDISC ODM Certified logo on certified versions of your product
- Acknowledgement and advertising through CDISC to the industry that your product(s) meet compliance criteria for the ODM version specified
- Alphabetical listing by company name of certified product(s) on our website with annual renewal
- Announcements in the CDISC eNewsletter and social media to mention products that have achieved ODM certification
- Publicity of ODM certified products and vendors at CDISC events
Fees
ODM Certification Fees:
The Initial Fee includes up to six days (48 hours) for an ODM Expert to perform the initial assessment, the conformity testing, documentation of the certification in a final report, inclusion of your company’s name and certified product(s) in the ODM Certified Product listing.
The Annual Renewal Fee will be invoiced with your annual membership dues and is to maintain ODM Certified Products on the CDISC web site.
The Update Fee applies to have the current version of a certified product certified against another version of ODM, or to certify a new version of a previously certified product. CDISC will charge only actual time and materials and any travel necessary to complete the certification activities provided the vendor has maintained CDISC Membership and ODM Certification Annual Fees.
ODM Certification Fees |
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Gold Members |
Platinum Members | |||||
| Total # of Employees in Organization | Initial Fee | Annual Fee |
Version Update Fee (must be current with annual fee) |
Initial Fee | Annual Fee |
Version Update Fee (must be current with annual fee) |
| >=1000 | $10,000 | $3,000 | T&M+Travel | $9,000 | $2,500 | T&M+Travel |
| 100 - 999 | $9,000 | $2,000 | T&M+Travel | $8,000 | $1,200 | T&M+Travel |
| 1 - 99 | $7,000 | $1,000 | T&M+Travel | $6,000 | $600 | T&M+Travel |
You must be a CDISC member to apply for ODM Certification. For complete program information, reference CDISC Operating Procedure (COP) 002.