Wed, 2014-08-27 00:00
What’s in a Value Level Metadata (VLM) Library?
SHARE has the capability to store and publish Value Level Metadata (VLM) content. Currently, the only CDISC standard describing VLM is Define-XML. Define-XML provides the structure for VLM along with some guidelines on when it’s useful, but it does not provide standard VLM content. The Define-XML v2.0 specification states that VLM should be applied when it provides information useful for interpreting study data, and that it need not be applied in all cases. Precisely what and where VLM should be used is determined by study implementers.
Since there are no hard and fast rules describing when to use VLM, what should be included in a SHARE library of VLM content? It might be useful to ask, “where is VLM being used today?” Based on input so far, most implementers add VLM where they think the regulatory reviewers might want to see it. Since many organizations are not yet using Define-XML as a machine-readable specification, but are instead creating it to fulfill an FDA submission requirement, implementers often add VLM for only the most very basic and obvious cases. How should the SHARE VLM content be published so that it would be useful to implementers? For those that are using VLM as a machine-readable specification, how are you using VLM?
A Proposal for Developing a VLM Library in SHARE
In line with current VLM usage, the SHARE team proposes to publish VLM for the most basic and obvious cases first. The VLM will be published as Define-XML v2.0 files and made available for download in eSHARE.
Tue, 2014-07-08 11:31
CDISC SHARE is a metadata repository (MDR) that supports the development, governance, publishing, and consumption of the CDISC standards in human and machine-readable formats. For more information about SHARE see the CDISC Website. eSHARE and iSHARE are parts of the overall SHARE system. They represent two separate ways to access SHARE content, as shown in the diagram below.
Wed, 2014-07-02 14:32
We were informed by Mr. Yoshiteru Chiba of CJUG that as of this October, the University of Tokyo’s School of Public Health will begin a course on the CDISC standards! The course will cover information on SDTM, SEND, ODM, CDASH, ADaM and more. Several familiar faces will be involved in instructing the course; please see the image below for details.
CJUG also held their annual “CDISC Workshop”event on 28 March 2014 at Shinagawa R&D Center at Daiichi Sankyo Co., Ltd. This conference, open only to CJUG members, was attended by 95 people. Keynote addresses were made by Ms. Yuki Ando of the Japan PMDA and Dr. M. Sano of Tokyo University. Topics ranged from
regulatory information to updates from standards team members.
Lastly, the monthly CJUG SDTM team meeting was held on Friday, 18 April at Nippon Kayaku Co., Ltd. The meeting was attended by 71 individuals, and seven new members joined at this event. This brings the total number of CJUG SDTM members to 102.
Wed, 2014-07-02 10:56
It was a great day to be at FDA with the DCDISC user group network. There were seven insightful presentations at this whirlwind meeting attended by almost 100 CDISC users from Government, Industry, and their service providers. FDA implementers were more active than ever and lively discussions rewarded all sides with a morning well spent.
Challenges emerging during the meeting included implementing standards in ongoing trials, maintaining traceability through reporting, and hitting a moving target as medicine and standards evolve. Proposed solutions included frequent and open communication with reviewers and collection of data using the CDASH standard.
Wed, 2014-07-02 08:44
Below is an interview with Dr. Wenjun Bao, Chief Scientist and R&D Manager of JMP Life Sciences in SAS Institute, Inc. Dr. Bao is also a member of the China CDISC Coordinating Committee (C3C).
Congratulations on winning the second place at this poster competition. Why do you think the judges see a winner in this poster?
The poster is titled, “The application of CDISC standards in adverse events analysis,” and was coauthored with Dr. Qin Huang and Dr. Jun Wang of CFDA. The judges really like what the software can do and how it can benefit the whole clinical trial study. They feel that JMP Clinical will enhance the clinical trial data analysis and quality, and make it possible to quickly find meaningful signals in safety data.
Wed, 2014-07-02 08:32
Shannon Labout (CDISC VP, Education) and I continued our trip from Shanghai to Tokyo, which took all day, but that seemed short compared to the trip to Shanghai (which took 19 hours longer than scheduled). We arrived at our hotel around 6:30 in the evening and promptly went to eat one of our favorite meals in Japan – okonomiyaki. This comfort food (basically a cabbage pancake that one cooks at one’s own table on a small metal grill) was just what we needed to prepare us for the following day.
Tue, 2014-07-01 15:41
Team CDISC made an official appearance at the CISCRP Medical Heroes Charity 5K run held at the beautiful San Diego Embarcadero waterfront at 6:30am on Monday, June 16. To my recollection, this is the first time that such an activity — as distinguished from the usual cocktails and hors d’oeuvre fare — has been held at a DIA meeting. Wizened DIA veterans are well aware of the delicate dance of trying to inconspicuously detect the names associated with semi-familiar faces encountered on the exhibit floor — the classic line is to ask "who are you working for these days?” as you study the badge without disclosing that you’ve also forgotten their name. And if you think that’s hard, imagine trying to recognize these once a year acquaintances when they’re dressed in shorts, tee shirts and sunglasses rather than business attire — sans name badge. Lots of waving and close-lipped smiling as you rapidly but fruitlessly scan your memory banks.
Tue, 2014-07-01 15:13
Released on 5 June by the New England Journal of Medicine (NEJM) is an article co-authored by Dr. Rebecca Kush (CDISC) and Dr. Michel Goldman (IMI). This article looks at the role that data standardization in clinical research can play when considering data aggregation, reuse and adverse event reporting - all with the goal of utilizing precious patient data to its fullest extent. The article has been published in the NEJM Perspective, available on the NEJM website here.
Tue, 2014-07-01 15:08
During May and into June, the SHARE team will continue to be busy on a number of fronts. In June we plan to begin beta testing the eSHARE site for machine-readable downloads of the CDISC standards. The eSHARE site will be part of the new CDISC web site that will be launched in June. The SHARE team has also been actively designing new forms of standards content for SHARE, including Research Concepts and explicit Value Level Metadata representations. A white paper describing our initial solution for Research Concepts will be distributed for review in June. Also during June, we plan to complete an initial proof-of-concept project toward a long-term Research Concept solution. Value-Level Metadata (VLM) blog postings started in May and will continue through June. We plan to publish a white paper describing how VLM content will be represented in SHARE, and exported in Define-XML format later in the summer.
Tue, 2014-04-22 14:36
CDISC Europe Interchange Success:
It is always a great pleasure to play a key role in planning and organizing for the CDISC Europe Interchange with the European CDISC Coordinating Committee (E3C). The 2014 Europe Interchange reached the highest attendance rate since 2008, with 100 additional attendees compared to the 2013 Europe Interchange. Over 300 people came to attend this event from 21 countries. The highest attendance rates were from France and the United States, followed by Belgium, Germany, United Kingdom, Denmark, Switzerland, China, Japan, South Korea, South Africa, Netherlands, Czech Republic, Portugal, Poland, India, Italy, Finland and Austria.
New education courses were offered this year. Six courses were offered on Monday and Tuesday, and three were held on Friday. Due to high demand for CDISC SDTM and Define-XML courses, additional classes were open to allow for more registrations.