e-Clinical Trials 2009

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The Workshop

PRE CONFERENCE WORKSHOP

Linking Electronic Health Record (EHR) and clinical trial systems, possibilities, added value and challenges
Tuesday 12 May 2009
Led by:	Gilbert van Zeijl (MSc) Medical Informatician MAASTRO CLINIC
About the workshop:
Last year a group from pharma and software industry, clinical and academic world brought out a political statement about the added value of electronic health records and its use for research. This workshop will scout the challenges and added value for different stakeholders on the road to linking EHR and eCRF.
Workshop agenda
13:00	Delegate registration and coffee
13:30	Session 1: Linking EHR and eCRF from the viewpoint of the pharma industry Outlining added value Discussing challenges Defining requirements
14:15	Session 2: Linking EHR and eCRF from the viewpoint of data managers Outlining added value Discussing challenges Defining requirements
15:00	Coffee break
15:30	Session 3: Linking EHR and eCRF from the viewpoint of the clinical world Outlining added value Discussing challenges Defining requirements
16:15	Session 4: Analysing the gap between the current situation (IST) and the envisioned situation (SOLL) in this workshop, resulting in a recommendation to all involved parties Where do viewpoints agree with each other? What are main differences between viewpoints? Wrapping up; recommendations to all stakeholders
17:00	Conclusion
17:10	Close of workshop
About your workshop leader
Gilbert van Zeijl has a master degree in both biology and informatics. He worked for many years as a free-lance database specialist in Europe and around the world. For 7 years Mr. van Zeijl has been working in the clinical and academic world in Maastricht, The Netherlands. He has been involved in data management of many clinical research projects including setting up an eCRF system and building clinical data warehouses. Recently Mr. van Zeijl successfully implemented a system for clinical data exchange between all 7 hospitals of the Province of Limburg, The Netherlands.
About your workshop company
MAASTRO, Maastricht Radiation Oncology, is a co-operation between MAASTRO clinic, the University of Maastricht (UM) and the University Hospital Maastricht (azM). The medical physics department of MAASTRO provides physics and technical support for MAASTRO Clinic, which offers state-of-the-art radiotherapy to more than 3000 cancer patients each year from the Limburg area in the Netherlands. MAASTRO clinic currently has 7 modern linear accelerators. A strategic highlight of MAASTRO is Computer Aided Theragnostics (CAT). See www.maastro.com for more details.

POST CONFERENCE WORKSHOP

Standard based electronic archiving of clinical trials: deciding on a long lasting storage strategy
Friday 15 May 2009
Led by:	Wolfgang Kuchinke Coordination Centre of Clinical Studies (KKS) Heinrich-Heine University Duesseldorf
About the workshop
	Electronic archiving of clinical trials represents a true challenge because of the complexity and size of the documentation and because more and more clinical information already arises electronically. This workshop will explore the conditions of standard based electronic archiving, covering regulatory, organisational, technical and economic aspects. It will lead you to a concept of integrated archiving of both study documents and study databases. Thus, it will take you through new developments helping you to make decisions about forward-looking secure long-term storage of clinical trials based on standards.
Workshop agenda
9:00	Delegate registration and coffee
9:30	Session 1: Requirements and challenges of electronic archiving Identifying the key issues in electronic archiving of clinical trials Document archiving (trial master file, investigator site file) Database archiving The central aspect: understanding the life cycle of documents Archiving from EDC systems Archiving from document management systems Is paper still necessary for archiving?
10:15	Session 2: Regulatory and organisational aspects GCP compliant archiving Part 11, Annex 11, and other laws and regulations Archiving in international trials: different national regulations? Different durations for storage of different documents Data protection aspects of archiving
11:00	Coffee break
11:30	Session 3: Standards for electronic archiving Advantages of standard based archiving Points to consider for TIFF, PDF, ASCII, XML CDISC archiving: is it sufficient? The problem of the representation level of documents Using the CDISC healthcare link for archiving Using electronic signatures for archiving documents
12:15	Session 4: Economic aspects and future trends in archiving Understanding cost factors in electronic archiving How is integration in archiving possible? Concept for an integrated standard-based archiving of the entire clinical study
13:00	Conclusion
13:10	Close of workshop
About your workshop leader
Dr. Wolfgang Kuchinke has an educational background in biology and clinical pharmacology. He received a doctorate at the University of Cologne in Germany. Since 2000 he has worked at the Coordination Centre for Clinical Trials (KKS) of the Heinrich-Heine University in Duesseldorf. He started with the management of clinical trials and has focused since on information technology using the internet for clinical trials. Recently, as a Transvac Manager, he is involved in the entry of regenerative biotherapies into clinical trials and the facilitation of international trials at ECRIN (European Clinical Research Infrastructure Network).
About your workshop company
KKSD is a centre for support of clinical trials located at the medical faculty of the University Duesseldorf in Germany. It conducts and assists in the entire spectrum of clinical research and helps their clients to meet legislative, regulatory and technical requirements. As an organisation member of the telematics platform (TMF) and ECRIN, KKSD is working on the realisation of an European infrastructure for electronic clinical trials.