Following are CDISC documents created with the input of its Sponsors and/or Members for your review:

• Governance Document
• Strategic Plan
  • COP-001-Standards Development
  • COP 002-Regulatory Communications
  • COP 003-Board Member Selection
  • COP-004-Solution Providers
  • COP-007-Audit Committee Charter

2nd Annual CDISC European Interchange, Paris, France, 25-29 April 2005

View presentations from 2005 Annual CDISC European Interchange

DIA eBusiness Conference, 22 October 2002

• IT-Based Patient and Research Networks: The European Experience, Tim Jaeger, MD, PhD (ppt)
  
• No One is as Smart as Everyone: CDISC and the Collaborative Standards Forum, Stephen Ruberg, PhD (pdf)
  
• "Using the CDISC Operational Data Model as an e-Archiving Solution, Wayne
  Kubick"(pdf)
  

DIA Workshop on Data Standards for Clinical Development, September 2002

• An Approach to Using CDISC Standards for the Development of eClinical Trials, Lynne Germscheid, Merck and Company (pdf)
  
• Integrating the HealthCare Enterprise; Using Standards to Improve Connectivity, Paul Vegoda, FHIMSS (ppt)
  
• Experience with the Patient Profile Viewer Pilot Project, Fred Wood, Procter & Gamble
  Pharmaceuticals and Michael Walega, Covance, Inc.(ppt)
  
• Emerging Standards for Health Information: Unexpected Opportunities and Challenges from the HIPAA "Health Reform Acts", David Kibbe, MD, NCHICA (ppt)
  
• Patient Profiles and Standard Submission Data, Jeremy Pool, PPD Informatics (ppt)
  
• Creating Data Standards for a Merged Company using CDISC Standards as a Foundation, Diane Wold, GlaxoSmithKline (ppt)
  
• ECG Waveform Data Submission Standards, Norman Stockbridge, FDA (ppt)
  
• IT-Based Patient and Research Networks: The European Experience, Tim Jaeger, MD, PhD, interActive Systems (pdf)
  
• Medical Imaging Standards in Clinical Trials, Richard Jacobs, Perceptive Informatics (ppt)
  
• The CDISC LAB Model, Phil Pochon, Covance (ppt)
  
• Data Standards and Related FDA Initiatives, Katherine Hollinger, FDA (ppt)
  
• The Ethical Will for the Paper CRF, Gary Lightfoot, DART (doc)

The Impact of CDISC on the Biotech Industry Wayne R. Kubick, VP Lincoln Technologies MassBiotech Council Meeting, Jan. 31st, 2003, Biostatistics and Clinical Data Management Cambridge, MA. (pdf)

"The Value of Standards" Center For Business Intelligence's 3rd Annual Electronic Clinical Trials Michele Thomas, GlaxoSmithKline (ppt)

E-Clinical Trials Cannes, France 11 September 2002 "Towards Worldwide Clinical Trial Data Standards - a Status Update", Dr. Johann Bruening, Schering AG (ppt)

ECG Waveform Data Submission Standards, Norman Stockbridge DIA Data Standards for Clinical Development 16 September 2002 (ppt)

June, 2002, 2nd Annual CDISC Clinical Data Connectathon was held 18 June 2002 in Chicago. The Who's Who lists those that participated in the event and what their demonstration entailed. Further information from the Connectathon is forthcoming. (pdf )

Drug Information Association's Annual Meeting, Chicago, IL, June 2002

• 2nd Annual CDISC Clinical Data Connectathon was held 18 June 2002 in Chicago. The Who's Who lists those that participated in the event and what their demonstration entailed. Further information from the Connectathon is forthcoming. (pdf )
  
• Drug Development and Electronic Submission Standards, Wayne Kubick (pdf)
  
• The Importance of Standards: FDA Initiatives, Randy Levin
  
• FDA/HL7/CDISC Initiatives: Working Together to Achieve the Vision (pdf)

"European CDISC Kick-Off Meeting", Frankfurt, Germany, 26 June 2002

• Overview of Meeting (Word doc)
• Presentation by Udo Siegmann, Rebecca Kush and Abdel Oualim (ppt)
• Presentations by:
  
  • Graham Bunn (ppt)
  • Olga Van den Dungin (ppt)
  • Tim Jaeger (ppt)
  • Petra Streng [Pierre Yves Lastik]
  • Guido Roumans
    
    
• Sign-up form for Participation in EU CDISC Activities (ppt)
  

Vision in Business Conference on EDC, Nice, France, 16-17 April 2002, Rebecca Kush, CDISC Joris Cauquil, Pierre Fabre and DMB Vision in Business Electronic Data Capture. (ppt)

Vision in Business eClinical Trials Conference, Tampa, Florida, 4-7 March 2002, Rebecca Kush, PhD, President, CDISC and Catalysis, Inc. (ppt)

Drug Information Association Meeting, Innovative Statistical Strategies in Today's Environment, March 2002

• The Implications of Data [and Metadata] Standards for FDA Statisticians, Steve Wilson, Dr.P.H. (Biostatistics), Deputy Director, Division of Biometrics II, CDER U. S. Food and Drug Administration (ppt)
• The Importance of Data Standards in Statistical Analysis, Wayne Kubick, Vice President, Lincoln Technologies, Technical Director, CDISC (ppt)
• CDISC Standards for Analysis Dataset Models (ADaM), Dave Christiansen, DrPH Consultant and CDISC Board Member (ppt)

February, 2002, CDISC and eClinical Directions, R&D Pharma Directions, London, England, Graham Bunn, Ph. D., Quintiles (ppt)

February, 2002, Pharma R & D Directions Conference, Cancun, Mexico, Rebecca Kush, PhD, CDISC and Catalysis, Inc., Stephen Ruberg, PhD, Eli Lilly & Company, Charles Jaffe, MD, PhD, AstraZeneca (ppt)

February, 2002, CDISC Education Committee Presents Industry Metadata Standards for Data Interchange, Kaye Fendt, Kevin Johnson, CDISC (pdf)

January 2002, Drug Information Association 5th Annual Workshop on Clinical Data Management, Tokyo Japan

• Overview, CDISC in Japan (pdf)
• DM group, Statistics & DM section, JPMA JPMA Questions and CDISC Responses (pdf)
• Stephen J. Ruberg, Ph.D., Eli Lilly & Company Presentation (ppt)
• European Experiences Implementing CDISC, Udo Siegmann, Parexel (ppt)
• FDA Viewpoint of CDISC, Steve Wilson, Dr.P.H. (Biostatistics), Deputy Director, Division of Biometrics II, Center for Drug Evaluation and Research, Food & Drug Administration (ppt)
• Why CDISC?A Pharmaceutical Company Viewpoint, Elaine Job, Global Head, Data Management Standards, Aventis Pharmaceuticals (ppt)

November 2001, XML Design Considerations in CDISC, Michael Miles, Senior Medical Data Management Analyst, GlaxoSmithKline (pdf)

October 2001, Web-based Clinical Trials, International Quality and Productivity Center, Boston, MA, Rebecca Kush, PhD, President, CDISC (pdf)

October 2001, CDISC Clinical Data Connectathon, held during the Drug Information Association's Clinical Data Management meeting in Paris France. The successful event was attended by approximately 200 people. (Who's Who at the CDISC Connectathon).

October 2001, Standards Update, P.Y. LASTIC and J. CAUQUIL, SFdS Biopharmacie et Santé -- Annual Meeting -- November 26th - Paris (pdf)

September 2001, Marcus Evans Conference: PharmaTech Summit, K. Fendt ( program )

• CDISC Session ( pdf)
• Team Status Update, W. Kubick ( pdf)
• Update on European Activities, U. Siegmann ( pdf)
• A Physician Views the CDISC Initiative, R. Tresley MD ( pdf)

July 2001, CDISC Proof-of-Concept Clinical Data Connectathon "Who's Who" at DIA Annual Meeting Denver, Colorado. Successful demonstration of Standard Operational Data Interchange Model for the biopharmaceutical Industry, 22 companies collaborated in a unique event to demonstrate that they could exchange data between their systems using a standard data model developed through the Clinical Data Interchange Standards Consortium (CDISC). Full story...

July 2001, IIR Conference on Clinical Data Management, A. Rolle ( pdf ) 

June 2001, Marcus Evans Conference on Web-based Clinical Trials, R. Kush ( pdf)

May 2001, DIA Standards Conference ( pdf)

• Clinical Trials: Importance of Metadata, John Silva, MD., National Cancer Institute ( pdf)
• Systems & Standards to Improve Clinical Trials , V. Nohria, G. Lightfoot, DevCo Pharmaceuticals and iBiomatics ( pdf)
• Representing Clinical Trials for Interpretation and Meta-Analysis, I. Sim, MD, PhD, Univ. of California, San Francisco ( pdf)
• The Future of Standards in Pharmaceutical Research and Development, K. Johnson, Inceutica ( pdf)
• Standard Mergers and Merging Standards, K. Howard, Pfizer ( pdf)
• Clinical Data and Emergent Clinical Standards, C. Shute, MD, PhD, ( pdf)
• Vocabularies and Content Standards, C. Shute ( pdf)
• XML Standards for Pharmaceuticals, J. Burke, Microsoft ( pdf)
• Identifying, Testing and Implementing Data Standards at a CRO: Strategies for Success, M. Walega, Covance ( pdf)
• The Data Archiving Challenge, S. Cassells, PHT Corp.( pdf)
• Interchanging Lab Data using the CDISC XML Model, S. Cassells ( pdf)
• Tower of Babel: Creating a Unified Glossary for Clinical Research, A. Gertel, iKnowmed ( pdf)
• CDISC/HL7 Synergy, L. Quade, Eli Lilly ( pdf)

March 2001 DIA Clinical Data Management Meeting

• "Why CDISC? A Pharmaceutical Perspective", E. Jobs ( pdf)
• "CDISC: A CRO Perspective", S. Kenny, L. Hauser ( pdf)
• CDISC Overview and Update, W. Kubick ( pdf)

March 2001 DIA Euro Meeting

• CDISC Tutorial, U Siegmann, R Kush, R Levin, S Cassells ( pdf)
• Session on Developing Standards for Clinical Trial Data, R Kush et al. ( pdf)
• EMWA and CDISC, J Klapproth ( p_blankdf)

December 2000 DIA West Coast Data Management ( pdf)

November 2000 DIA European Clinical Data Management  ( pdf)

November 2000 AMIA

• R.D. Kush CDISC ( pdf)
• C.G. Chute Cancer Data & Clinical Data Standards ( pdf)
• Standardizing Information Flow in Clinical Trial Protocols
  • J. Gennari ( pdf)
  • J.C. Niland ( zip ) (990KB)

October 2000 Society for Clinical Data Management ( pdf)

June 2000 DIA Annual Meeting

• J. Becker ( pdf)
• W. Kubick ( pdf)
• S. Wilson ( pdf)

March 2000 DIA CDM Technical Analysis Team / ODM ( pdf)