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Come review this year’s accomplishments and preview future efforts in harmonizing biopharmaceutical and healthcare standards at the 2005 International Interchange of the Clinical Data Interchange Standards Consortium (CDISC) during the week of 19 September in Bethesda, Maryland at the Bethesda Marriot.
The conference will focus on implementation and interoperability. The conference will begin on Tuesday, 20 September with keynote presentations from Dr. Janet Woodcock, Deputy Commissioner for Operations, Food and Drug Administration, and Dr. Kenneth Buetow, Director of National Cancer Institute’s Center for BioInformatics. Presentations by CDISC leaders, members, and representatives of HL7, NCI, and FDA will focus on 2005 progress, implementation of CDISC standards and use case studies, as well as future strategic direction. The conference will last two full days, 20-21 September.
On the evening of 20 September, a reception and discussion forum will focus on standards- based interoperability and where future industry efforts should focus. The reception sponsored by Microsoft,SAS,and IBM will include presentations and demonstrations by leading vendors and other companies involved in CDISC-related standards implementations. On line registrations will be open until 12 September. After that, registrations can only be accepted at the Interchange in Bethesda.
http://www.cdisc.org/events/index.html |
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CDISC Industry Advisory Board Meeting (Corporate Sponsor Representatives) Introduction to CDISC Course and End-to End Workshop
Keynote Presentations CDISC Roadmap Highlights of CDISC 2005 Case Studies: SDTM and ODM Interoperability Demo and Reception Sponsored by SAS and Microsoft
Protocols: Glossary; PR Group Use Cases; BRIDG Session Case Studies: LAB, ADaM, etc. End-to-End; Healthcare Link FDA Session
STDM,SDS,ODM, and LAB Courses (CDISC Joint Team Meeting) Friday, 23 September STDM Course continued (CDISC Joint Team Meeting)
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| The success of CDISC is due to you, our members, volunteers and supporters. We are continually searching for better ways to communicate to you so you get the information you want without being burdened by too much. We hope to accomplish this with a new and updated newsletter format, Harmony. We have condensed the length and will be distributing this bi-monthly instead of quarterly. This way you will receive all the updates you are used to, but in smaller doses.
We would greatly appreciate your feedback. Let us know if you like the new format or make suggestions on how we can improve our communications to you. Please send all comments to Sheila Camhi, CDISC Operations Associate, at scamhi@cdisc.org. All feedback received will be answered.
CDISC would also like to encourage you all to provide content for the newsletters. This can be case studies, implementation stories, questions and answers, and any topic you feel would be relevant to the CDISC mission. Please submit content to Sheila Camhi, scamhi@cdisc.org and we will be happy to work with you to make the CDISC Harmony newsletter a truly collaborative effort.
Version 3.1.1 (V3.1.1) of the CDISC Study Data Tabulation Model Implementation Guide: Human Clinical Trials has been released by the CDISC Submission Data Standards (SDS) Team. V3.1.1 is based upon Version 1.1 of the SDTM, which was posted in May 2005. This newest version includes new features, corrections, clarifications, and examples all of which are described in detail in Section 10.6 of the document. V3.1.1 also incudes a new domain model for Protocol Deviations, which is posted separately.
Although V3.1.1 represents the most current, approved version of the SDTMIG, the SDS Team will continue to work on providing additional examples to represent more complex data domains, such as signs and symptoms, pharmacokinetic concentrations and parameters, and microbiology. In addition, the team plans to continue work on developing additional models and examples for intervention and event data that include both spontaneous and pre-specified treatments and terms.
Visit
http://www.cdisc.org/models/sdtm/v1.1/index.html
to download SDTMIG V3.1.1..
On 17 August 2005, the CDISC Board of Directors elected Ed Helton, PhD of SAS Institute as the Chair-elect of the Board. Ed has been on the CDISC Board since January 2003 and is also the Chair of the Board Technical Support and Guidance Committee. Dr. Helton will be Chairelect for the 2006 calendar year while David Hardison, PhD of SAIC holds his term as Chair of the CDISC Board. Dr. Hardison has been on the Board since January 2003 and is also Chair of the Board Financial Oversight Committee.
Stephen Ruberg, PhD, of Eli Lilly has held the position of Chair of the CDISC Board for the last four years. He will remain as Past-chair for the year 2006.
A new set of Board members will be elected by the Industry Advisory Board and the CDISC Board during the Interchange later this month. CDISC is grateful for the expertise and dedication of all of its Board members!
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CDISC has been invited to submit articles
to a number of journals, including Applied Clinical Trials, Good Clinical Practices Journal, Drug Discovery and DIA Journal, the latter potentially being an opportunity for an issue dedicated to standards. We would like to know who would be willing to write or help write an article that has some relevance to
the CDISC standards, e.g. implementation experiences, use cases, case studies, or a more general topic. Don’t worry about whether you are an expert author; if you have a case study, we can get you help with the writing!
Please e-mail
Rebecca Kush (rkush@cdisc.org) if you are interested |
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Julie Evans, Director of Technical Services for CDISC moderates an online Discussion forum of hot topics related to industry standards. We hope to develop a living forum used to foster discussion to provide assistance and to share experiences.
LAB Model
Operational Data Model (ODM)
Submissions Data Model (SDS)
Analysis Dataset Model (ADaM)
Standard Data Tabulation Model (SDTM)
Protocol Representation Group (PRG)
Define.xml
Glossary Group
GeneralTopics
Frank Newby, CDISC’s VP of Education and Member Services would enjoy hearing from you. He can coordinate on-site training at your facility with one of our outstanding instructors. CDISC offers a variety of specialized education and training courses on the theory and practice of using the CDISC standards and to provide the tools and information needed to implement these within organizations.
Introduction to CDISC
Introduction to SDTM
LAB Data Model Theory & Application
ODM Theory & Application
SDS v3.1 Theory & Application
SEND Theory and Application
For more detailed information and additional specialized courses please see
our website at
http://www.cdisc.org/
events/2005InterchangeTrainingCourseDescriptions1.doc
CDISC’s Study Data Tabulation Model Audio CD/Transcript
Learn how to operate more efficiently, speed your product approvals and boost your bottom lines by adopting FDA suggested CDISC standards.
Gary Walker and Wayne Kubick explain what CDISC is, what the term “data standards” means and how sponsor companies and regulatory staff can benefit from standardized
data.
To order this transcript: http://www.fdanews.com/wbi/cds/1934-1.html |
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A CDISC group working on the
eSource Data Interchange
(eSDI) initiative has produced a DRAFT document “Leveraging the CDISC Standards
to Facilitate the use of
Electronic Source Data within Clinical Trials”.
This will be posted on the CDISC website for open public comment until 17 October.
CDISC 2005 European Interchange
24-27 April 2006
Berlin Marriot
Germany
TWO FULL Conference Days
24-25 April Training Courses
26-27 April Interchange Conferences
Stay tuned for more details….. |
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CDISC is pleased to award STAR recognition to the following members for their unwavering support of the CDISC mission and goals for the past five consecutive years.
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Adobe Systems Inc.
Corporate Member
Application Architects, LLC Associate Member
DZS Software Solutions
Associate Member
Global IQ
Associate Member
Harvard Clinical Research Institute Associate Member
INO Therapeutics
Corporate Member
Insightful Corporation
Associate Member
PharmaNet
Corporate Member
For a complete list of CDISC Members see our website. |
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11-17 HL7 Working Group Meeting
San Diego, California
15-16 CDISC Educational Opportunity
SDTM & SDS v3.1 Training
United Kingdom
19-23 CDISC International Interchange
Bethesda, Maryland
27-30 Electronic Clinical Trials 2005
Improving Electronic Processes in
Clinical Drug Development
London UK
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6-7 CDISC Education Opportunity-
SDTM Training
San Francisco, CA
13-14 CDISC Education Opportunity-
SDTM Training
San Diego, CA
18-19 CDISC Seminars—
The CDISC Standard: Four Models
Working in Unison (End-to-End Workshop)
CDISC: A Management Perspective
Munich, Germany |
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STARS LIGHT OUR WAY..
