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29 Oct 2012

CDISC International Interchange 2012 initiated with one of the most interesting educational sessions that I have ever attended in a very long while, Train the Trainer session! The session took place on Sunday, 21 October 2012 at the Renaissance Harborplace Hotel in Baltimore, MD. This course was developed specifically for CDISC authorized instructors so that CDISC training can be delivered in the best possible way to our members and stakeholders.





The session was tailored to train instructors and presenters on global teaching and presentation skills that would motivate and stimulate the profound attention of the attendees in the material delivered. The session started at 9:00 AM and was supposed to end at 5:00 PM, but it did not end until 5:45 PM where active participation and excitement of discovery kept the attendees interested until the last minute. Attendees, who are also CDISC instructors were urged to participate continuously, analyze and discover new ideas and training methods throughout the day. Creative and positive input led to self-discovery of new teaching techniques, this atmosphere of active and analytical participation helped the attendees discover a new variety of interesting and exciting teaching methods even before they received instructions and notes from the instructor.

21 Aug 2012

The FDA recently published their announcement of a public meeting to discuss Solutions for Study Exchange Standards. The notice includes directions for how to register to attend the meeting (the email address, however is incorrect. Please refer to correct address at the end of this entry), and also a list of questions related to the use of standards, including asking for input on comparing HL7 transport standards to CDISC ODM.



This may be our best opportunity to convince FDA that an XML transport standard based on ODM for CDISC SDTM, SEND and ADaM content would be a better solution for submitting data than use of HL7 healthcare standards. We believe this forum will highlight the advantages of using the CDISC Operational Data Model (ODM), which is the basis for define.xml and a current component of the FDA study data standards. ODM has been successfully adopted by many researchers in both industry and academia, as well as technology vendors for transferring clinical data, metadata and terminologies with audit trail in a fully compliant manner.

21 Aug 2012

CDISC would like to thank all those who followed the metadata patent issue. Late last week the US Patent Office officially issued a “Final Rejection” notice to the patent applicant. According to the US Patent Office: “A final Office action," in this case a final rejection, “issues when the applicant's response to the prior Office action fails to address or overcome all issues. An applicant’s only response to a final Office action is either compliance with the requirements or appeal to the Trademark Trial and Appeal Board.”


8 Aug 2012

In January 2012, CDISC was contacted by Nanping (Lisa) Li, Healthcare
Strategy & Business Development Executive, IBM, who informed us
that CDISC would be an important focus for IT standards in China, in
particular, with respect to a new program that has been launched between
China and the US through AmCham. Ms. Li sits on the Steering Committee
of the Healthcare Cooperation Program (HCP).




to a Press Release from 26 June: “AmCham China's Healthcare
Cooperation Program (HCP) today signed a memorandum of understanding
(MOU) with the Health Human Resources Development Center of the Chinese
Ministry of Health, opening a path to increased cooperation. The MOU
will help foster multi-level exchange between China and the US in the
healthcare sector and provide a platform for high-level US-China
dialogue on healthcare reform, medical personnel training and technology
exchange.” See this link for the full press release.


According to Jun Zhou, Executive Director, AmCham is
working to make it easier for companies to do business in China; his key
project is the Healthcare Cooperation Program. The two workshops that
AmCham and IBM planned, with CDISC as a core theme, took place in
Beijing on 16 July and Guangzhou on 19 July. AmCham and IBM sponsored
the workshops, along with support from CDISC, especially Sheila Leaman,
CDISC Manager of Global Relations.



7 Aug 2012

Winner gets the CDISC Innovation Award with Recognition from HHS-ONC, DIA, FDA and CDISC!



At this year’s DIA meeting in Philadelphia on 26 June, CDISC, HHS/ONC and FDA issued a ‘challenge’ to use EHRs for regulated research. Specifically, research study sponsors were challenged to use at least two different electronic health record systems at different sites to conduct a multi-site, multi-visit, standards-based regulated research study. The panelists at DIA spoke on the feasibility of this challenge, based upon technology and data standards and processes that have been developed over the past decade. In addition, a case study was presented during this session about a research study being conducted currently at Florida Hospital using the Cerner EHR system. Despite the potential and demonstrated benefits of this approach, the clinical research industry has not yet embraced these new methods and standards to conduct research studies.


This challenge will provide FDA, HHS/ONC and CDISC a means to assess the remaining barriers as well as the opportunities to streamline regulated research and increase its capacity throughout the US and the world as EHR adoption is being encouraged and increasing rapidly. Wayne Kubick, Chief Technology Officer (CDISC), spoke first at the DIA session: “CDISC has been doing demonstrations of its Healthcare Link methodology for years now, at HIMSS and at DIA. By adopting the CDISC-IHE profiles used in the CDISC Healthcare Link solution, EHRs can readily implement the standards and profiles to enable the collection of a high quality research dataset that is needed for any regulated research study.”


6 Aug 2012

The CDISC China Coordinating Committee (C3C) was initiated in 2008 when Sandy Lei of J&J came to China and initiated a CDISC group. President, Rebecca Kush, also visited that year and a half-day workshop was held with Lei and Kush as speakers. The first Chair, Simon Wang of Parexel, was elected and a Charter was written. The C3C has since sponsored two Interchanges at Fudan University and more recently initiated a great group that has been validating translations (provided by Absolute Systems Clinical Data Co., Ltd.) and performing translations of the CDISC standards into Chinese. This group is known as CSTAR (CDISC Standards Translation and Review).


6 Aug 2012

“Japan’s Strategy in the Era of Global Development” was the title of
the presentation given at the CDISC Japan Interchange on Thursday, 12
July by Tatsuya Kondo, M.D., Ph.D., Chief Executive, Pharmaceuticals and
Medical Devices Agency (PMDA). This leader of Japan’s Regulatory
organization provided a very informative keynote presentation expressing
appreciation of the value of standards. Many thanks to Dr. Fukushima,
head of the Translational Research Informatics Institute (TRI) in Japan,
for extending the invitation. After his presentation, Dr. Kondo and
two of his staff met with leaders from CDISC Global Operations, TRI,
CDISC Board (Dr. Lastic) and the CDISC Japan Coordinating Committee.


Dr. Kondo stated that “the purpose of Pharmaceutical
Affairs is to improve the public health through regulations to secure
quality, efficacy and safety of pharmaceuticals and medical devices and
take necessary measures to promote R&D, where the reliability must
be verified”. There are three primary roles for PMDA in their quest to
improve the public health and safety of Japan: 1) to reviewing
applications for marketing approval of pharmaceuticals and medical
devices; 2) to conduct safety measures, and 3) to provide relief to
people who have suffered from adverse drug reactions or infectious


27 Jul 2012

CDISC retains IP ownership of all of its standards to ensure that CDISC Standards remain open and free, Even when the standards are translated into other languages, the IP belongs to CDISC.



CDISC standards are created through a consensus-based process that includes many different people who contribute their time and expertise. Thus, the value should serve everyone and the IP be protected. Some standards in other industries were developed in a manner that included proprietary portions such that users were charged royalties. The desire to prevent royalty charges or ownership by any one organization or individual formed the basis for the CDISC IP Policy that is now posted on our website.

23 Jul 2012

Last week CDISC sent a letter to many of our members alerting them to
a potentially damaging and costly patent application which is currently
under review by the United States Patent Office. The text of the letter
is below and was prompted in part by a thread on Linkedin which can be
found here.


The jist of the patent is this: a
company, DataSci, filed a patent application in 2009 that effectively
patents the use of metadata in clinical research. If this patent is
granted there is a real possibility that a fee will be due to the patent
holder for any use of metadata over the internet for every study done
by any BioPharmaceutical company, academic research institution,
government agency – basically ANY clinical research. See the original
email below for more details and links that provide additional


Almost immediately after the email went
out CDISC was contacted by Pharmaceutical, Biotech, Government, CRO and
Technology company representatives company representatives asking how
they could help prevent this patent from being approved. Most have
forwarded the original email to their legal counsel and are looking into
the process to protest this patent. Several of the large Pharma
companies are also discussing how to combine efforts to fight this
patent application.


CDISC appreciates all this effort and
the support shown by our members. We will periodically update this blog
with the status of these efforts.


Original email follows:

23 Jul 2012

This year marks the 10th anniversary of the Japan CDISC Coordinating Committee (J3C), and in celebration of this milestone, CDISC honored their long-standing support at the 2012 Japan Interchange in Tokyo.


Questions and comments are welcome here!