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17 Aug 2014

Dr. Rebecca Kush, Landen Bain and I represented CDISC at the eSource Physician Checklist Retreat held in San Francisco, California, 26-27 June. This was a collaborative meeting organized and led by UCSF’s Dr. Laura Esserman and Sue Dubman, with representatives from several other organizations, including the FDA and EMA participating via teleconference. The goal of the retreat was to discuss the development of an eSource Physician Checklist to augment the existing CDISC Healthcare Link standards and create a plan for an implementation project.

 

16 Aug 2014

The theme of the CDISC Asia Pacific/Japan Interchange, held 28 July – 01 August in Tokyo, was “Transcending Geographic Lines for the Betterment of Clinical Research.” Evidence of transcending geographic lines was clearly visible at this well-attended CDISC Interchange.  

 

16 Aug 2014

The last several weeks have been both busy and fulfilling for many CDISC staff, as we made our annual trip to the Asia-Pacific region for both the CDISC Education Summit in South Korea (22-25 July) and the CDISC Asia-Pacific/Japan Interchange in Tokyo, Japan (28 July – 01 August).

 

16 Aug 2014

We have enjoyed a relationship with the Translational Research Informatics Institute (TRI) since we signed a Memorandum of Understanding with them in 2009. This has included joint publications, presentations at respective conferences, TRI membership and participation in CDISC activities, and the real pleasure of seeing how TRI has implemented CDISC standards with increasing prowess over the past five years. Last week, prior to the CDISC AP/Japan Interchange, we visited TRI in Kobe, Japan. We took the Shinkansen to Kobe the morning of 22 August, arriving just after noon.

15 Aug 2014

The official announcement of the notification “Basic Principles on Electronic Submission of Study Data for New Drug Applications” was made by the Evaluation and Licensing Division of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare (MHLW) on 20 June 2014. Following on this, the Pharmaceuticals and Medical Devices Agency (PMDA) held a briefing session for the operation of this notification on 24 July 2014 in Tokyo.

 

15 Aug 2014

 

SDTM

The SDTM SHARE sub-team recently reviewed and approved the metadata for SDTM v1.2/SDTMIG v3.1.2 and SDTM v1.3/SDTMIG v3.1.3. As for SDTM v1.4/SDTMIG v3.2, the team aims to finalize it after reconciling domain-level metadata, at which will be updated in SHARE when ready.

 

Supplements

15 Aug 2014

Despite just being released in Q2 of 2014, a number of freely available tools are already available to work with Dataset-XML files. The recently-introduced CDISC Dataset-XML standard enables the interchange of tabular datasets, like SDTM or ADaM, using ODM-based XML, and provides a convenient alternative to SAS V5 XPORT files. Tools supporting Dataset-XML are listed on the publicly accessible “CDISC Dataset-XML Resources” page on the CDISC Wiki. Early versions of many of these tools were available before Dataset-XML was released as a final standard.

8 Jul 2014

 

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.

2 Jul 2014

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.

2 Jul 2014

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.