CDISC Presentations and Publications
As one of the main evangelists of the CDISC standards in Europe, Jozef Aerts of XML4Pharma has given a good amount of presentations on this topic.
Also, we have written a number of articles on the use of CDISC standards which have been published in high-quality magazines.
Presentations
- 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.
- "CDASH, electronic medical records and ODM – status update". CDISC German Speaking User Group, Berlin 2009:
- 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?". Presentation: "An Analysis of Recent Guidance - How Does it Help? How Does it Hurt?".
- "Bridging the gap between ODM and SDTM: Tools for creating SDTM datasets from ODM data, CDISC European Interchange 2008, Copenhagen".
- "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.
- X.Bessette (i-Clinics) and J.Aerts: "Implementing CDISC LAB, ODM and SDTM in a Clinical Data Capture and Management System - How we did it".
CDISC 2006 European Interchange Conference, Berlin, April 2006.
- "Tools for working with CDISC ODM, Lab and define.xml Standards – What is available ?". CDISC 2006 European Interchange Conference, Paris, April 2005
- "Implementing the CDISC ODM standard", PSDM Workshop on CDISC, Weesp, June 2003
Publications
- 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
- "CDISC Standards Energize EDC", Applied Clinical Trials, October 2006 (available online)
- 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.
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