HL7 CDA R2 Based Document Sharing in Biomedical Research: Design of a Severe Adverse Event (SAE) Report Document

Abstract

Background: The IT infrastructure requirements of Medical Research Networks (MRNs) are increasing with time and technological progress. The demand for modularity, interoperability and the support of standards calls for new strategies. In the healthcare domain, the application of Integrating the Healthcare Enterprise (IHE) profiles is a widely established approach. Hence, pursuing this approach may lead to a future-oriented system architecture enabling the integration of biomedical research with the healthcare domain. Objectives: The present paper focuses on the document sharing aspect based on HL7 Clinical Document Architecture (CD A), especially on the CDA document design of a Severe Adverse Events (SAE) report document taken from a clinical trial in the field of paediatric oncology. Methods: The CDA document design for the pre-existing SAE form was based on the CDA R2 specification and state-of-the-art implementation guidelines issued by the ELGA GmbH and IHE. To facilitate interoperability with third party information systems the focus was on using external vocabulary and code lists as well as predefined CDA structure templates. Results: A CDA document design for an SAE report was developed. The document was at least Level 2 and to a large extent Level 3 coded. Conclusions: eCRFs can b e designed on the basis of CDA R2 while interoperability in large MRNs has to b e ensured through validation against strict business rules. Further questions regarding IT infrastructure which result from particular requirements of MRNs have to b e dealt with in the future.