Extended Cooperation in Clinical Studies through Exchange of CDISC Metadata between Different Study Software Solutions

Summary

Objectives: Our objectives were to analyze the possibility of an exchange of an entire clinical study between two different and independent study software solutions. The question addressed was whether a software-independent transfer of study metadata can be performed without programming efforts and with software routinely used for clinical research.

Methods: Study metadata was transferred with ODM standard (CDISC). Study software systems employed were MACRO (InferMed) and XTrial (XClinical). For the Proof of Concept, a test study was created with MACRO and exported as ODM. For modification and validation of the ODM export file XML-Spy (Altova) and ODM-Checker (XML4Pharma) were used.

Results: Through exchange of a complete clinical study between two different study software solutions, a Proof of Concept of the technical feasibility of a system-independent metadata exchange was conducted successfully. The interchange of study metadata between two different systems at different centers was performed with minimal expenditure. A small number of mistakes had to be corrected in order to generate a syntactically correct ODM file and a “vendor extension” had to be inserted. After these modifications, XTrial exhibited the study, including all data fields, correctly. However, the optical appearance of both CRFs (case report forms) was different.

Conclusions: ODM can be used as an exchange format for clinical studies between different study software. Thus, new forms of cooperation through exchange of metadata seem possible, for example the joint creation of electronic study protocols or CRFs at different research centers. Although the ODM standard represents a clinical study completely, it contains no information about the representation of data fields in CRFs.

Keywords

Standardization - clinical trial - medical informatics - metadata - CDISC

• References

• 1 http://www.tmf-ev.de
• 2 Kuchinke W, Ohmann C. “eTrials” werden zur Routine. Dtsch Arztebl 2003; 100 (047) A 3081-4.
• 3 Aerts J. The impact of XML on Pharmaceutical R&D. Clinical Trials, DrugDev123 2002 Editorial IT (1.2.2002), 212 http://www.drugdev123.com
• 4 Alschuler L, Bain L, Kush R.. Improving data collection for patient care and clinical trials, March 26, 2004. Science Next Wave. American Association for the Advancement of Science http://nextwave.sciencemag.org/
• 5 Kush R.. The world of standards for clinical research. Pharmatech 2003, Business Briefing pp 100-2.
• 6 Fetsch T, Verplancke P. Erfolgsfaktoren für eTrials. DZKF 2003; 5/6 24-8.
• 7 CDISC, Overview of the CDISC Operational Data Model for clinical data acquisition and archive, CDISC, 10.10.2001 www.cdisc.org
• 8 Kacher D.. CDISC ODM White Paper: Vendor extensions to the CDISC ODM DTD, CDISC 10.10.2001. www.cdisc.org
• 9 Iberson-Hurst D. The CDISC Operational Data Model: Ready to Roll?. Applied Clinical Trials 2004 July 1, 2004
• 10 Hume S. Connecting at the Connectathon. Applied Clinical Trials 2001 Sep 1, 2001