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:
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:
Mark your calendars for the next CDISC European Interchange on 7-11 April 2014 in Paris, France. Information will be posted soon on the CDISC website.
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:
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:
The CDISC Japan User Group Recent Meetings and Updates (by Yoshiteru CHIBA)
Recently held meetings:
The CDISC Japan User Group (CJUG) hosted a CDISC SDTM team meeting on Friday, 12 April 2013 at Dainippon Sumitomo Pharma Co., Ltd in Tokyo, Japan where 30 people attended this event. The conference started with an online presentation: "About PhUSE" provided by Mr. Senk Frank. During the second session, the team discussed the SDTM data implementation updates. And the last session was concluded with a presentation by Mr. Takashi MISAWA of ACRONET Corporation. Mr. MISAWA who is a member of LISaS (an SDTM Sub-Team) presented on the “SDTM Filesize Issue Updates”.
Another CJUG SDTM team meeting was held on Friday, 10 May 2013 at The Institute of Japanese Union of Scientists & Engineers (I-JUSE) in Tokyo where 32 people attended this conference.
Recently, four new members have joined the CJUG team:
Various presentations were provided throughout the meeting on 10 May, among which was a talk by Dr. Hideto YOKOI of Kagawa University Hospital Department of Medical Information. Dr. Hideto presented through an online webinar as he was on a business trip in the U.S. attending a meeting with the U.S. Food and Drug Administration. His presentation topic was "Challenge of linking EHR to EDC". During the second session, the team discussed the SDTM data implementation latest updates. The topics included creating a CRF sub-group, creating a Trial Design Model sub-group, EDC Builder sub-group and Protocol sub-group.
Upcoming CJUG meetings:
The next CJUG SDTM Team meeting will be held on 14 June 2013 at the University of Tokyo. The meeting is scheduled from 13:00 to 17:00. During this conference, the SDTM data implementation activity sub group will discuss creating a CRF sub-group, EDC Builder sub-group, Trial Conductor sub-group and study reviewers guide sub-group. In addition, a presentation on “About next eCTD” will be provided by Ohbayashi. Furthermore, another talk about “VISITNUM/VISIT -SV vs. Other Domain-“ will be provided by Mr. OHNO of CHUGAI clinical research center CO, LTD. Mr. OHNO is a member of LISaS which is an SDTM sub-team.
Follow the link to know more about the purpose and benefits of the CDISC User Networks.
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:
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.
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.