Over the last few years our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SDTM, SEND and ADaM.
This post shines a spotlight on the lesser known Operational Data Model (ODM) standard, which is often overlooked as it's not required by any regulators. Why should you be interested in it? Because it can be used as a standard way to define forms, independent of the data collection system. These forms can then be turned into organizational standards, driving data quality and consistency. Finally they can be used to drive your data collection system. In short, they put you in control.
With the right tools in place sponsors and CROs can define data collection standards while remaining flexible in their EDC choice. They can also take control of their EDC build to save time and money. Standardizing your data collection means greatly reduced future study build cost due to re-use and increased consistency between studies.Read More