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CDISC Global Coordinating Committees

 

CDISC Coordinating Committees (3Cs) were founded in 2002 to support global CDISC initiatives within specific regions of the world and to provide regional feedback to the central CDISC organization. They differ from User Groups in that they are sanctioned directly by the CDISC Board of Directors and CDISC Executive Operations. The primary 3C activities are defined in collaboration with CDISC Executive Operations; these activities receive support from CDISC Operations and require effective communications between the two groups.

 

CDISC 3Cs represent the CDISC organization around the globe, and help to strengthen relationships with international and local entities as well as organizations in their respective regions. The primary aim is to promote the value of CDISC and its vision and mission. One of the essential responsibilities of the 3Cs is to organize and promote annual CDISC Interchanges in their regions.

 

The current active CDISC Coordinating Committees are:

 

  • European CDISC Coordinating Committee (E3C)
  • Chinese CDISC Coordinating Committee (C3C)
  • Japanese CDISC Coordinating Committee (J3C)

 

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Updates on the Latest Activities of the CDISC Coordinating Committees

 

The European CDISC Coordinating Committee (E3C):

 

E3C is an organization founded to support CDISC initiatives within Europe and to provide regional feedback to the central CDISC organization. The E3C completed its election process in November 2012, during which they elected the following exceptional members to support the CDISC mission and vision by being 3C members in Europe:

 

  • Carine Javierre of Sanofi
  • Nathalie Sabin of Clinical Data
  • Mark Lambrecht of SAS
  • Andrea Rauch of Boehringer-Ingelheim
  • Stephen Pyke of GSK (and a CDISC Board Member)

 

The E3C is organizing the CDISC European Interchange this year, it is scheduled for 22-26 April 2013 in Bad Nauheim/Frankfurt, Germany. In addition, the E3C will hold a face-to-face meeting 23-24 January 2013 to review / discuss the EU Interchange abstracts and go over preparations and agenda for 2013 in relation to their continuous support to the CDISC organization in Europe.

 

Information on the EU Interchange conference sessions and education courses offered, as well as registration details and pricing can be all found through this link. And submission of abstracts is extended until 23 January 2013 through this link.

 

 

 

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The Japanese CDISC Coordinating Committee (J3C)

 

The Japan CDISC Coordinating Committee (J3C) is an organization founded to support global CDISC initiatives within Japan and to provide regional feedback to the central CDISC organization.

 

The J3C Announces a Call for Nominations for J3C members - Deadline Extended Until 28 February 2013

 

The main responsibilities of the J3C include:

  1. Develop an action plan each year, in collaboration with CDISC Executive Operations, that is aligned with the CDISC Strategic Goals and the CDISC Operational Goals for that year.
  2. Organize and promote CDISC Interchanges in Japan with prior approval of dates, contracts and other related obligations from CDISC Executive Operations.
  3. Provide assistance regarding the scheduling and content of authorized training and other educational seminars in Japan, working with the CDISC lead for Education.
  4. Liaise with Japanese regulatory authorities, other appropriate institutions and standards developing organizations in close collaboration with CDISC Executive Operations.
  5. Form value-added collaborations with organizations in Japan that can further the CDISC vision and mission communicating interactions to CDISC Executive Operations.
  6. Assist in the creation and coordination of User Networks/User Groups in Japan, as appropriate, and ensure that the feedback from the User Networks / User Groups is consolidated and communicated back into the CDISC organization through the CDISC Executive Operation liaison to the 3C and CDISC Communications representative. 
  7. Place documentation for the J3C in the CDISC Portal and communicate activities through CDISC website and eNewsletters.

 

Applicants from IT vendors, Academia/Hospital and SDOs should represent CDISC member organizations and must support the CDISC mission and understand the value of the CDISC Data Standards. They agree to actively support the development, adoption and implementation of the CDISC Data Standards. They must also have the capacity to make their time available for their J3C duties. These include attending 3 face-to-face meetings a year, attending monthly teleconference calls and undertaking individual tasks. In addition, applicants should be Japanese.

 

Candidates can nominate oneself or others for a J3C position. Candidates must provide a resume and a motivation letter expressing their interest to be on the J3C. If you feel the J3C is an organization you would like to be a part of, please provide your CV and a motivation letter to Diana El-Harakeh by Thursday, 28 February 2013.

 

J3C and CDISC Japan User Group (CJUG) Latest Meetings and Activities

 

 

The CDISC Japan User Group (CJUG) recently hosted a CDISC SDTM Team meeting on 8 March 2013 at ASKLEP Inc. Akihabara Office in Tokyo, where 32 people attended this event. The meeting launched with an online presentation on “Managing Data Quality and Standards Compliance with OpenCDISC” by Max Kanevsky of OpenCDISC/PINNACLE21. During the second session, the team discussed latest updates on the SDTM data implementation. And finally, the conference concluded with a presentation “About PhUSE” by Hajime SHIMIZU of Takeda Pharmaceutical Company Limited, by LISaS (a sub-team of SDTM).

 

 

Another CJUG Workshop was held on 12 March 2013 at CAC EXICARE where 80 attendees shared experiences and updates on the CDISC standards. The third SDTM Team meeting was held on 12 April 2013 at Dainippon Sumitomo Pharma Co., Ltd; during this half-day meeting, an online Presentation “About PhUSE” was provided by Senk Frank, in addition Yasutaka MORIGUCHI of Santen Pharmaceutical Co, presented on “SDTM Filesize Issue Updates” By LISaS, and finally an SDTM Data implementation activity sub-group meeting was held to discuss various topics about creating CRF sub-sub-group, creating Trial Design Model group, Protocol sub-group and EDC Builder sub-group.

 

Future User Group Meetings in Japan:

The SDTM team invited speakers to present on the following topics:

 

  1. "Challenge of linking EHR to EDC", the meeting will be held at Kagawa University Hospital on 10 May 2013.
  2. The second presentation will be on the following topic: “About next eCTD", the meeting will be held at Meta-cube Mr. Ohbayashi on 14 June 2013.
  3. Another presentation will be offered on 12 July 2013 by a representative of the Ministry of Health, Labor and Welfare (MHLW), Office of Clinical Trial Promotion Research and Development Division Health Policy Bureau. Presentation topic will be determined soon, stay tuned to our website.

 

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The Chinese CDISC Coordinating Committee (C3C)

The Chinese CDISC Coordinating Committee (C3C) is an organization founded to support global CDISC initiatives in China and to provide regional feedback to the central CDISC organization.

 

The C3C Announces a Call for Nominations for 2 C3C Members and a Second Vice-Chair:

 

The C3C recently held a face-to-face meeting to discuss the recruitment of additional members to support CDISC activities in 2013. According to the new CDISC Coordinating Committees (3C) charter, each committee should consist 12 members maximum. Currently, the C3C consists of 10 members with two new positions open to candidates.

 

The C3C would also like to nominate another vice-chair, in addition to Victor Wu, who is the current vice-chair of the committee.

 

The primary responsibilities of the C3C include:

 

  1. Organization of annual CDISC Interchanges in China with prior approval of dates, contracts and other obligations from CDISC Executive Operations.
  2. Assistance in scheduling and coordinating authorized CDISC training and other educational seminars in China, liaising with the CDISC Executive lead for Education.
  3. Liaison with regulatory authorities in China, other appropriate health institutions and standards developing organizations, working in close collaboration with CDISC Executive Operations.
  4. Establish value-added collaborations with organizations in China that can further the CDISC vision and mission, communicating interactions to CDISC Executive Operations.
  5. Overseeing the creation and coordination of any User Networks/User Groups in the region as deemed appropriate, ensuring feedback from the User Networks / User Groups is consolidated and communicated back into the CDISC organization.

 

Membership in the C3C will provide a unique opportunity to give support and feedback to the CDISC organization. C3C members represent CDISC in China!

 

Applicants must support the CDISC mission and understand the value of the CDISC Data Standards. They agree to actively support the development, adoption and implementation of the CDISC Data Standards. They must also have the capacity to make their time available for their C3C duties. These include attending face-to-face meetings, attending monthly teleconferences and undertaking individual tasks. In addition, applicants must reside in China.

 

Candidates can nominate oneself or others for a C3C position. Candidates must provide a resume and a motivation letter expressing their interest to be on the C3C.

 

If you feel the C3C is an organization you would like to be a part of, please provide your CV and a motivation letter to Sheila Leaman.

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This year, the Inaugural Asia-Pacific Interchange will be held in Singapore on 18-22 February 2013. Further details on this conference sessions and the educational courses can be found through this link.

 


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