J3C and U.S. Government Health IT Members:


The CDISC Japanese Coordinating Committee (J3C) is actively meeting with the U.S. Government Health IT representatives to discuss the best way of compliance with data standards. A recent meeting was held at the University of Tokyo Hospital on Tuesday, 3 September from 16:00 to 17:00. Representatives of the U.S. government present were: Dr. Douglas B. Fridsma of HHS/ONC, Dr. Theresa Cullen of the U.S. Department of Veterans Affairs Veterans Health Administration, Jane Earley of the Pharmaceuticals and Medical Devices Office of Health and Consumer Goods, Ian A. Clements of the International Trade Specialist Office of Japan and Korea, Eriko Yajima (an interpreter), and Gregory Taevs, Yasue Morimoto and Hiroyuki Hanawa of the Embassy of USA in Tokyo. J3C members who attended this meeting were Ken Toyoda (J3C Chair), Hidetoshi Misawa (Vice Chair), Tukada Yoshio (Past Chair), Satoru Tsuchiya and Yoshiteru Chiba. Upon his return, Dr. Fridsma contacted CDISC President, Dr. Rebecca Kush, to report on the success of this trip. He also met with representatives of the PMDA while there. Many thanks to our J3C friends for their hospitality and discussions about CDISC standards.


Additional Updates from Japan:


The UMIN Center recently published a Japanese version of the "UMIN INDICE Lower level data communication Protocol for CDISC ODM" document. This document is intended for system development, illustrating how Clinical Study Data from HIS/EHR or EDC is being sent electronically to direct UMIN INDICE. Please see the following link to access the document in Japanese: http://www.umin.ac.jp/cdisc/dl/api_ver27/INDICE_CDISC_API_Ver27.pdf. The English version was issued recently and can be access through the following link: http://www.umin.ac.jp/cdisc/dl/api_ver27/INDCIE_CDISC_API_Ver27_e.pdf. Please note that Professor Kiuchi from the University of Tokyo Hospital UMIN Center will be presenting at the CDISC Interchange in Bethesda in November.


AP3C Update:


At the Inaugural CDISC Asia Pacific Interchange in February 2013, there was discussion of initiating an Asia Pacific CDISC Coordinating Committee (AP3C). This would not replace the other 3Cs in Asia, but would allow representatives from additional countries in the Asia-Pacific region to belong to a 3C. A charter has now been drafted, thanks to Dr. Ken Toyoda and Dr. Kiyoteru Takenouchi. A face-to-face meeting is scheduled for 9 December in Hong Kong to discuss this charter and the viability of such a group. Interestsed representatives from Asia Pacific countries are being recruited. Please contact Andrea Vadakin (avadakin@cdisc.org) with recommendations.


Diana Harakeh CDISC Communications Manager


Strength through Collaboration


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