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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.

Conference Presentations

• 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.



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



• 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.

Upcoming conferences (presentation confirmed)

• Making CDISC End-to-End Possible: Gap Analysis And The New Study Design Model Standard.
  Clinical Data Standarisation & Management 2011, London, June 2011

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, Schlossbergstr. 20, 78224 Singen, Germany. Phone: +49 7731 975044