Thu, 2014-10-23 00:00
This November in Bethesda marks the first time CDISC Education is offering the new Implementation course in the Standard for the Exchange of Non-clinical Data, otherwise known as SEND, at an International Interchange. SEND is a CDISC standard that provides the structures and implementation rules for the submission of data from single- and repeat-dose toxicity studies and carcinogenicity studies, and is built on the Study Data Tabulation Model (SDTM).
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.
Sun, 2014-08-17 08:40
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.
Sat, 2014-08-16 11:30
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.
Sat, 2014-08-16 10:15
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).
Sat, 2014-08-16 09:00
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.
Fri, 2014-08-15 10:45
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.
Fri, 2014-08-15 10:30
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.
Fri, 2014-08-15 10:10
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.
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.