List of publications and conference presentations
publications not on CDISC standards and before 2001
Publications regarding CDISC standards
- Submitting clinical data to the FDA in XML format.
Regulatory Rapporteur, Vol.2, No.6, June 2005.
- CDISC Set the Standard. (reprint available on request)
European Pharmaceutical Contractor, Winter 2005.
- CDISC Standards Energize EDC.
Applied Clinical Trials, October 2006 (available online).
- Integral Values - integration of EDC and Electronic Health Records.
(reprint available on request)
European Pharmaceutical Contractor, September 2009, p.16.
- Current Applications and Future Directions for the CDISC Operational Data Model Standard: A Methodological Review
J. Biomed. Inform. 60, 352-362 (2016)
- Towards a Single Data Exchange Standard for Use in Healthcare and in Clinical Research
Studies in Health Technology and Informatics, 248, 55-63 (2018)
- What's Up with LOINC and UCUM? From EHR Records to LB Dataset in Just a Few Minutes
Full paper CDISC virtual European Interchange April 2020
- Fully Automated Generation of COVID-19 SDTM Datasets from Electronic Health Records
Full paper CDISC virtual US Interchange October 2020
- Automated generation of CDISC Biomedical Concepts Starting from Healthcare Terminologies
Full paper CDISC Europe Interchange April 2021
Conference Presentations
Important: By opening or downloading one of the following presentations, you automatically agree with the conditions of use. So, better read them first!
- Implementing the CDISC ODM standard.
PSDM Workshop on CDISC, Weesp (NL), June 2003.
- Affordable Technology for working with CDISC ODM and Lab Standards.
Parexel International Conference for Clinical Trial Technologies, Berlin, October 2004.
- Tools for working with CDISC ODM, Lab and define.xml Standards – What is available?.
CDISC European Interchange Conference, Paris, April 2005.
- 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.
- 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.
- ODM seeks SDTM – the missing link revisited.
CDISC International Interchange Conference, Washington, October 2007.
- CDISC Roadmap Outline: Further development and convergence of SDTM, ODM & Co.
CDISC German Speaking User Group Meeting, Berlin, 2007.
- 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?".
- Bridging the gap between ODM and SDTM: Tools for creating SDTM datasets from ODM data.
CDISC European Interchange Conference, Copenhagen, April 2008.
- CDASH, electronic medical records and ODM – status update.
CDISC German Speaking User Group, Berlin 2009.
Presentation available on request.
- Integration of EHRs with CDISC, CDASH and ODM – A European Initiative.
CDISC European Interchange Conference, Budapest, April 2009.
Presentation available on request.
- Towards a Fully Machine-Readable Protocol: The New ODM Extension for Trial Design / Protocol.
CDISC European Interchange Conference, London, April 2010.
- Towards a Fully Machine-readable Protocol: from ODM-extension to Patient Study Calendar.
CDISC International Interchange Conference, Baltimore, November 2010.
- CDISC end-to-end using one standards set and one format.
DIA Euromeeting 2011, Geneva, 28-30 March 2011.
- Define.xml: Good Practices and Stylesheets.
CDISC European Interchange Conference, Brussels, April 2011.
- Multipurpose usage of the new "Study Design Model in XML" (SDM-XML)
CDISC European Interchange Conference, Stockholm, April 2012.
- The future of ODM
CDISC European Interchange Conference, Bad Neuheim, April 2013.
- It's the semantics stupid! The last mile (or kilometer?) in interoperability between healthcare, clinical research and regulatory agencies
CDISC European Interchange Conference, Bad Neuheim, April 2013.
- A new transport standard for electronic submissions in XML: Dataset-XML
CDISC European Interchange Conference, Paris, April 2014.
- Less is more - A visionary View on the Future of
CDISC Standards
CDISC European Interchange, Vienna, April 2016.
- The CDISC Moonshot - Can we do it?
CDISC European Interchange, London, April, 2017.
- CDISC Standards in the Age of Artificial Intelligence
CDISC European Interchange, Berlin, April, 2018
- From Machine-readable CDISC Standard Specifications to the e-Protocol
Phuse EU Connect, Franfurt, November, 2018
- Open Rules for CDISC, Web Services and the SHARE 2.0 API
CDISC European Interchange,Amsterdam, April, 2019
- Implementing the CDISC Library API in software applications: first experiences
Phuse Connect,Amsterdam, November, 2019
- The Use of LOINC and UCUM in Clinical Research
LOINC Conference, Mataro, Barcelona, October 2019
- What's Up with LOINC and UCUM? From EHR Records to LB Dataset in Just a Few Minutes
CDISC European Virtual Interchange, April, 2020
List of additional materials with links
Movie of the presentation and the demo
- Generating FDA-ready submission datasets for new COVID-19 therapies directly from Electronic Health Records using the new COVID-19 LOINC codes
LOINC Virtual Conference, October, 2020
Remark: presentations at smaller, local conferences and user group meetings, as well as seminars at universities are not included in the list.
Jozef Aerts is a renowned speaker at international conferences
For publications before 2001, please visit the Computer Chemistry Consultancy website.
XML4Pharma, Katzelbachweg 18, 8052 Thal, Austria
