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21 CFR 11
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Presentations and Workshops

Presentations
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CDISC: Towards Fully Integrated Standards
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VIB: The Evolution of Data Management in Pharma Amsterdam, Netherlands. November 25-26, 2008.
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Event information here.
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CDISC Roadmap
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CDISC International Interchange 2008 Arlington, VA, USA. October 27-31, 2008.
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Event information here.
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Current e-Source Acceptance
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DIA Euro Meeting 2008 Barcelona. March 3-5, 2008.
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Event information here.
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The e-Clinical Trial: CDISC’s Roadmap for a Better Process
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DIA. The Quest to Enable the Electronic Clinical Trial Baltimore, MD, USA. December 6-7, 2006.
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Event information here.
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Trustworthy Data in the Electronic Age: How CDISC Can Help.
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DIA. The Quest to Enable the Electronic Clinical Trial Baltimore, MD, USA. December 6-7, 2006.
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Event information here.
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The Ever Expanding Role of the ODM
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DIA 16th Annual CDM Conference. Basel, Switzerland. November 5-8, 2006.
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Event information here.
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The e-Clinical Trial: CDISC’s Roadmap for a Better Process
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A presentation that examines the CDISC technical road map and how the CDISC standards will support the eClinical process.
DIA 42nd Annual Meeting Philadelphia, PA, USA. June 18, 2006.
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Event information here.
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The Ever Expanding Role of the ODM
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The CDISC ODM was designed to provide a vendor-neutral, platform-independent means of exchanging and archiving electronic clinical data. However, over the last few years the model has been leverage in a number of unexpected ways.
This presentation will provide the audience with new material that reports on the use of the ODM as the CDISC transport standard, its role in the submission of data to the FDA, work performed in using the ODM in the transportation of standard case report form metadata and the extension of the ODM for the transmission of trial registry information for the World Health Organisation.
CDISC Euro Interchange 2006 Berlin, Germany. April 24-27, 2006.
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Event information here.
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CDISC Update Seminar
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Seminar will review the present status of the CDISC models, provide a progress update on the ODM, SDTM, discussions with the FDA and the CDISC Roadmap .
Phase Forward 2006 European Users Conference Ascot, UK. April 5, 2006.
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Event information here.
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Standard eCRFs from CDISC ODM and SDTM
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DIA Creating Clinical Trial Efficiencies through Standard Data Collection Arlington, VA, USA. January 25, 2006.
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Event information here.
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The ODM and Define.xml
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PhUSE Heidelberg, Germany. October 11, 2005.
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2004 CDISC Global Research Project
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DIA 41st Annual Meeting Washington, DC. USA. June 30, 2005.
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The ODM: Easing the Regulatory Burden?
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DIA 41st Annual Meeting Washington, DC. USA. June 30, 2005.
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Reinforcing the Need and Deployment of Standards
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DIA Annual Euro Meeting Lisbon, Portugal. March 2005.
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CDISC ODM and the Regulations
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US Food & Drug Administration Washington DC, USA. November 4, 2004.
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Clinical Data Archive. Does the ODM do the Job?
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International Conference for Clinical Trial Technologies Parexel Akademie, Berlin, Germany. October 14-15, 2004.
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Event information here.
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Impact of CDISC Standards.
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The presentation will cover the CDISC standards, how they impact industry and the benefits to be gained from compliance.
Managing Clinical Trial Results: Maximising the Efficiency of Clinical Data Programmes The Hatton. London, UK. October 11-12, 2004.
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Continuing Evolution of Clinical Data Standards
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World Pharma IT Congress The Brewery, London, UK. September 27-28, 2004.
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Event information here.
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Data Standardisation using CDISC
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The presentation covers the means by which data interchange standards can be leveraged to improve data interchange
Partnering with Central Labs, ECG and Imaging Labs London, UK. June 23-24, 2004.
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CDISC Standards, Where Next?
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The presentation looked at some of the current initiatives being undertaken within CDISC and with partner organisations.
ARCS Annual Meeting - CDISC Standards: The Holy Grail of Data Management Sydney, Australia. June 7, 2004.
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CDISC Standards: Flexibility and Opportunity
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eResearchTechnology European User Group Copenhagen, Denmark. May 19, 2004.
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Moderator for the session entitled 'Views of the EDC/eCT Market
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Moderated discussion covering the current EDC, eCT market place.
2004 Bio-IT World Conference + Expo Boston, USA. April 2004.
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Leveraging Standards
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The presentation covers how organisations who adopt standards gain opportunity and operational flexibility.
2004 Bio-IT World Conference + Expo Boston, USA. April 2004.
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CDISC Update
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Update for the Association of Clinical Data Management. Undertaken on behalf of CDISC
ACDM Annual Meeting Bristol, UK. February 2004..
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CDISC Update
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Update regarding CDISC to the EDM Forum. Undertaken on behalf of CDISC
EDM Forum Meeting Geneva, Switzerland. November 2003..
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CDISC Case Studies
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Presentation on CDISC Case Study material
CDISC Euro Meeting Basel, Switzerland. November 2003.
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CDISC in Europe
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Presentation on CDISC activities in Europe
1st CDISC Interchange Bethesda, VA, USA. October 2003.
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The NHS in Your Pocket
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Presentation on mobile data capture technologies used for subject data collection.
Note: NHS is the UK National Health Service
The NHS in your Pocket Møller Center. Churchill College, Cambridge University. August 2003.
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Workshops
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CDISC End-to-End Workshop
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DIA 2nd Annual Clinical Forum. Ljubljana, Slovenia. October 20-23, 2008.
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eClinical Workshop
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A workshop detailing the concepts behind eClinical trials
DIA. The Quest to Enable the Electronic Clinical Trial. Baltimore, MD, USA. December 6-7, 2006.
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CDISC End-to-End Workshop
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CDISC US Interchange. Bethesda, MD. September 25, 2006.
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CDISC End-to-End Seminar
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A seminar detailing how the CDISC models work end-to-end
DIA 42nd Annual Meeting. Philadelphia, PA, USA. June 18, 2006.
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The CDISC ODM
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Bay Area CDISC User Group. South San Francisco, CA, USA. January 26, 2006.
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ODM Course
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CDISC Course. Rahway, NJ, USA. January 23, 2006.
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ODM Course
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CDISC Course. Somerset, NJ, USA. December 2, 2005.
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The CDISC Standard: Four Models Working in Harmony
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A seminar detailing how the CDISC models work end-to-end
Frontier Sciences. Buffalo, NY, USA. November 22, 2005.
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CDISC Standards: A Practical Tutorial
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DIA Four Worlds - One Vision: Delivering Quality Data Effectively. Prague, Czech Republic. November 6, 2005.
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ODM Course
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US CDISC Interchange. Bethesda, MD, USA. 22 September 2005.
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The CDISC Standard: Four Models Working in Unison
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US CDISC Interchange. Bethesda, MD, USA. September 19, 2005.
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From Clinician to Submission: How the ODM can improve your process
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Exelixis. South San Francisco, CA, USA. July 25-26, 2005.
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From Clinician to Submission: How the ODM can improve your process
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SAIC. McLean, VA. USA. July 18-19, 2005.
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ODM Course
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NNIT. Copenhagen, Denmark. June 14, 2005.
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ODM Course
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Japan 1st CDISC Interchange. Tokyo, Japan. June 9, 2005.
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eClinical Trials Workshop
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A workshop detailing the concepts behind eClinical trials
BIO-IT. Boston, USA. May 16, 2005.
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Benefits And Challenges With ePRO
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DIA ePRO Workshop. Arlington, VA, USA. April 2005.
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eClinical Trials Workshop
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A workshop detailing the concepts behind eClinical trials
DIA Annual Euro Meeting. Lisbon, Portugal. March 2005.
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eClinical Trials
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A workshop detailing the concepts behind eClinical trials
DIA Three Worlds One Voice. Amsterdam, Netherlands. November 7, 2004.
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CDISC/CenterWatch Survey & eClinical Metrics
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A workshop presenting the results from the CDISC Research Projects on the attitudes to the adoption of e-Clinical and EDC technologies. Also covered an examination of e-Clinical metrics.
2004 CDISC EU Interchange. Brussels, Belgium. May 2004.
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XML Technology
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A workshop covering XML, XML technologies and the practical use of the CDISC ODM and LAB models.
2004 CDISC EU Interchange. Brussels, Belgium. May 2004.
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