Evidence & Performance Blog

We almost all know what CDISC is. It is a consortium that develops and maintains clinical data standards, like SDTM (Study Data Tabulation Model) and ODM (Operational Data Modeling).

The purpose of SDTM is to store clinical trial data, in XPT format together with standardized and organized metadata.

The purpose of ODM is to store not only clinical data, but also all data belonging to clinical trials (protocol, queries, DCF, data, metadata, audit-trail …) in XML format.

On the other hand we have the HL7 standard. Standardized messages related to the electronic patient file used to exchange patient data across the hospital structure. Typically a record could contain patient’s information, their consultations, their prescriptions etc…

Those two different worlds try to get closer to each other; in fact they deal with the same information, because some of the clinical data is already captured in the patient’s record. It would be a high benefit if some data coming from the hospital could already be integrated in the clinical trial.

The BRIDG Model has been designed to link both clinical research data and patients file data.

Of course, both standards are quite different, so the challenge lies in the integration of one standard with the other.

Initiated a couple of years ago, the BRIDG project demonstrates that data integration is not easy, and cannot be done over a night.

But what will be done in a long term period? Keep both entities and bridge them together? Wouldn’t it be more profitable to have a unique standard for both? But is it feasible?

More information can be found here: HL7, CDISC, BRIDG.

Additional information can also be found here: http://www.clinpage.com/article/the_future_of_odm_sdtm_and_cdisc/C12