ODM – The Operational Data Model
What is the ODM?
The ODM is a CDISC standard which allows clinical systems to exchange data using XML (Extensible Mark-up Language) and which defines the content and structure of Case Report Forms (CRFs) or a clinical database.
It can contain metadata* and data**, and can describe everything that has gone on in a clinical database.
* The metadata portion describes the study design and any changes to the design as a result of protocol amendments.
** The data portion can be a snapshot of the data at a specific time, a series of transactional updates to data, or a complete archive of all captured data including any changes and audit information etc.
ODM data is an ideal archive format because it is vendor neutral, portable and can be read anywhere. Furthermore, ODM data supports a transactional model where any changes to data can be exported from a live database. This makes the ‘streaming’ of ODM data and the subsequent conversion to datasets easier and faster.
Business Benefits of Using ODM
Streamlined study specification
Used in database specification, ODM’s vendor neutrality allows sponsors and CROs to exchange designs and agree on amendments quickly and easily.
Libraries of reusable study designs
ODM facilitates reuse of study metadata by being vendor neutral – there is no need to create libraries of metadata for each different data collection system. This enables the ability to simply drag and drop design elements from study to study. Formedix recently assisted a major pharma company in the release of a sizeable ODM library which is freely available for download – you can access it here.
Automated build of Electronic Data Capture (EDC) solutions
With ODM it is possible to specify a study independent of the system it will be implemented in, then use that specification to build the desired EDC system once it is chosen. This level of automation means a higher quality EDC build with less validation required. Some systems support direct import of ODM metadata, while others can be generated using 3rd party products that build systems from the ODM.
Automated generation of archive and submission ready CRFs
Complete archive and submission ready CRFs can be generated from ODM metadata and data. Extensions to the ODM allow companies to add their own ‘look and feel’ without requiring each of their EDC providers to invest in specialist coding efforts.
Sam Hume at AstraZeneca recently presented a compelling use case for the ODM for submission ready CRFs. His presentation can be found here.
Data exports in a standard format
Sponsor companies typically work with multiple CROs and Pharma partners. Now instead of asking each CRO or EDC vendor to package their data in a specialised dataset format with all of the associated time and cost, they can, at the press of a button, receive snapshot and transactional ODM files containing all their data and metadata in a single standardised format.
Time and cost savings for your company
The ODM standard is focused on the operational portion of a study and as such is unlikely to be regulated for. This misses the point however – ODM is not a standard that needs to be regulated for. It’s not a standard that people implement because they have to. Companies around the world (including the largest EDC and Electronic Patient Reported Outcomes (ePro) players: Medidata, PhaseForward, Datalabs, PHT, eRT) are implementing ODM support in their products and processes because it saves them and their customers time and money.
Formedix’s own clients have reported a 68% reduction in study build and review and approval times along with 30-50% savings in CRO study operational costs.ODM is driving real world cost savings today.
Formedix Products which use the ODM to help you in your Clinical Trials Process:
- OriginTM Study Modeller – A dedicated CDISC ODM Study Database Design and Specification Tool
- Origin TransformTM for Paper CRF – Used in conjunction with OriginTM Study Modeller to automatically produce print ready CRFs.
- Origin TransformTM for Your EDC Partner – Used with OriginTM Study Modeller for 3rd Party EDC system auto-generation including database and eCRF presentation.
- Origin TransformTM for SRCRF – Used with OriginTM Study Modeller to output Submission Ready Case Report Forms (SRCRFs).