CDISC ODM Standard

The Operational Data Model (ODM) provides a format for representing the study metadata, study data and administrative data associated with a clinical trial.

It represents only the data that would be transferred among different software systems during a trial, or archived after a trial.

It need not represent any information internal to a single system, for example, information about how the data would be stored in a particular database.

The ODM model assumes that a study's clinical data will consist of several kinds of entities. These include:

• subjects
• study events (a series of forms connected to an event)
• forms (aggregations of item groups)
• item groups (groups of items that will be analyzed together)
• items (single data item such as Hb%)
• annotations (comment applied to any of the above)