Table 1.

Characteristics of both models for administrative data

Patient record : HL7/CDA	Clinical study : CDISC/ODM
Only one patient	Several patients
One visit per document	Several visits for the same patient per message
Document identifier + patient identifier	Clinical trial identifier + document identifier
Detailed and complete information on the patient	Absence of administrative information on patients.
Links between the documents of the same patient	References to other clinical trials