FH-Prof. Dr.

Jozef Aerts




Development  of open standards for design of clinical studies, exchange and archival of clinical data and of electronic submissions to the FDA

Integration of electronic health records with data capture for clinical research (CDISC, CDA, FHIR)

Exchange of in health data between systems that use different standards (HL7, OpenEHR, ASTM,  …) 


The use of RESTful web services in Medical Informatics and Clinical Research and its Implementation in Europe. Health Informatics meets eHealth. Proceedings of the 11t eHealth 2017 Conference, IOS Press, 2017.

Current Applications and Future Directions for the CDISC Operational Data Model Standard: A Methodological Review, Journal of Biomedical Informatics, Volume 60, April 2016, Pages 352–362. Authors: Sam Hume; Jozef Aerts; Surendra Sarnikar; Vojtech Huser.

An Alternative CDISC-Submission Domain for Laboratory Data (LB) for Use with Electronic Health Record Data, the European Journal for Biomedical Informatics, 2015: 11(1):en2-en9

Generating a caBIG Patient Study Calendar from a Study Design in ODM with Study Design Model Extension, CDISC Journal Nr. 1, October 2011.

Integral Values - integration of EDC and Electronic Health Records, European Pharmaceutical Contractor, September 2009, p.16.

CDISC Standards Energize EDC, Applied Clinical Trials, October 2006.

Submitting clinical data to the FDA in XML format, Regulatory Rapporteur, Vol.2, No.6, June 2005.

CDISC set the standard, European Pharmaceutical Contractor, Winter 2005.

Kuchinke W, Aerts J, Semler SC, Ohmann C: CDISC standard-based electronic archiving of clinical trials; in: Methods Inf Med. 48(5) 2009, S. 408 – 413

Kuchinke W, Aerts J, Semler SC, Ohmann C: Möglichkeiten für eine Standard basierte Archivierung von Dokumenten und Daten in klinischen Studien;
in: mdi – Forum der Medizin-Dokumentation und Medizin-Informatik; Hrsg: BVMI / DVMD; 1 / 2009, S. 35 – 36.

 Präsentationen auf internationale Konferenzen

The use of RESTful web services in Medical Informatics and Clinical Research and its Implementation in Europe. eHealth Summit Austria 2017, Vienna, May 2017

The CDISC Moonshot - can we do it? 
CDISC European Interchange Conference, London, April 2017

Open Rules for CDISC Standards (poster)
CDISC European Interchange Conference, London, April 2017

ELGA meets FHIR (mit E.Jaritz, R.Mischak), eHealth Summit Austria 2016, Wien, Mai 2016 (Poster)

Less is more: A Visionary View on the Future of CDISC Standards
CDISC European Interchange Conference, Wien, Mai 2015

SDTM Validation Rules in XQuery.
CDISC German-speaking User Group, Eschborn, September 2015

CDISC Standards May Harm Your Health - Unless You SHARE Them.
CDISC European Interchange Conference, Basel, May 2015

A new transport standard for electronic submissions in XML: Dataset-XML.
CDISC European Interchange Conference, Paris, April 2014

The future of ODM.
CDISC European Interchange Conference, Bad Nauheim, April 2013.

"It is the semantics stupid!". The last mile (or kilometer?) in interoperability between healthcare, clinical research and regulatory agencies.
CDISC European Interchange Conference, Bad Nauheim, April 2013.

Multipurpose usage of the new "Study Design Model in XML" (SDM-XML)
CDISC European Interchange Conference, Stockholm, April 2012.

Define.xml: Good Practices and Stylesheets.
CDISC European Interchange Conference, Brussels, April 2011.

CDISC end-to-end using one standards set and one format.
DIA Euromeeting 2011, Geneva, 28-30 March 2011.

Towards a Fully Machine-readable Protocol: from ODM-extension to Patient Study Calendar.
CDISC International Interchange Conference, Baltimore, November 2010.

Towards a Fully Machine-Readable Protocol: The New ODM Extension for Trial Design / Protocol.
CDISC European Interchange Conference, London, April 2010.

Integration of EHRs with CDISC, CDASH and ODM – A European Initiative.
CDISC European Interchange Conference, Budapest, April 2009.

Bridging the gap between ODM and SDTM: Tools for creating SDTM datasets from ODM data.
CDISC European Interchange Conference, Copenhagen, April 2008.

An Analysis of Recent Guidance - How Does it Help? How Does it Hurt?
DIA Euromeeting Barcelona 2008: Session "Guidance and Regulations in the Age of Electronic Records: Over-interpretation and unnecessary Burdens. Is Risk Assessment the key to Practicality?".

ODM seeks SDTM – the missing link revisited.
CDISC International Interchange Conference, Washington, October 2007.

From Protocol to Submission. The Value of using CDISC Standards. Experiences from a long-time implementer.
The Changing World of Clinical Trials - European Clinical Research Conference, European eClinical Conference, 16th Annual European CDM Conference, Basel, November 2006.

Implementing CDISC LAB, ODM and SDTM in a Clinical Data Capture and Management System - How we did it. (together with Xavier Bessette, i-Clinics Belgium)
CDISC European Interchange Conference, Berlin, April 2006.

Tools for working with CDISC ODM, Lab and define.xml Standards – What is available?.
CDISC European Interchange Conference, Paris, April 2005.

Affordable Technology for working with CDISC ODM and Lab Standards.
Parexel International Conference for Clinical Trial Technologies, Berlin, October 2004.

Sonstige Präsentationen

Gastseminar "Neuere Methoden in der Medizinischen Informatik", Institut für Medizinische Informatik, Universitätsklinikum Münster, Titel: "Die Zukunft des CDISC ODM Standards", Februar 2016

CDISC User Group Meering, Berlin, September 2013

XML und Pharma
Johner-Institut für IT im Gesundheitswesen, Konstanz, September 2011.

CDISC Roadmap Outline: Further development and convergence of SDTM, ODM & Co.
CDISC German Speaking User Group Meeting, Berlin, 2007.

Implementing the CDISC ODM standard.
PSDM Workshop on CDISC, Weesp (NL), June 2003.-        


Chemie Studium an die Universität Leuven (Belgien)

Doktorarbeit in Chemie und Kristallografie an die Universität Leuven (Belgien)