New Initiatives Highlighted at the 2015 CDISC Interchange

Lots of new initiatives showed promise at the CDISC 2015 Interchange conference in Chicago on November 9-13.  The EHR2CDASH (E2C) project demonstrated the potential of healthcare link technologies used with the CDISC standards. The E2C XPath statements used to grab HL7 C-CDA/CCD document content will be stored in SHARE to support the implementation of CDASH forms that can be pre-populated with EHR content. A group of CFAST TA standards development stakeholders reviewed the new processes and tools that will be used for developing the Prostate Cancer standard. BiomedicalConcepts continue to garner attention as a key element of the semantic layer in the CDISC standards model. The growing CDISC standards model so important to the SHARE work was on display during the poster session. Use of the ODM standard was highlighted, including an extension to support its use in modern hand-held devices. There was quite a bit of enthusiasm and interest in SHARE activities, as evidenced by the crowd at the SHARE booth (read Anthony Chow's blog for more detail).

Most notably however, it seemed that 2016 was being talked about as a transformative year for CDISC. So many of the new initiatives previewed at the 2015 Interchange will begin to show their impact in 2016. Many of the new SHARE tools will begin to be used more broadly next year, especially in support of TA standards development. We plan to generate our first TA specification document from SHARE next year that includes new content such as Rules and Examples. The beginnings of a protocol standard will be available in SHARE next year. The SHARE API being piloted in 2015 will roll into production in 2016. In addition to these new developments, significant new foundational standards versions are scheduled for next year, including CDASH v2.0 and ODM v2.0. The list of new CDISC projects and deliverables slated for next year is long. It’s a bit daunting to look at the entire list, so we'll stick with our agile approach and take it one sprint at a time. The results should make for an interesting 2016 Interchange.


* A CDISC wiki account is needed to access content on the SHARE wiki space

Comments

Post a Comment

Popular posts from this blog

Value Level Metadata, Vertically Structured Datasets, and Normalizaton

Image
As part of the work to implement Value Level Metadata in SHARE, as well as to author a Define-XML Implementation Guide article, this will be the first of a series of posts on the topic of Value Level Metadata. These posts target a more technical audience, however the Define-XML IG article will include less technical jargon. Future posts will cover additional Value Level Metadata topics and examples. Value Level Metadata (VLM) is metadata that constrains a variable definition based on the value of another variable(s). VLM was originally specified in Define-XML v1.0 as a mechanism for providing the additional metadata needed for software to more accurately interpret these constrained variables.  For example, VSORRES is a variable with structural metadata of  DataType=”Text” and Length=”200”. However, when VSTESTCD=”DIABP” that definition is constrained by VLM to use DataType=”integer” and Length="3". In this case, the value of DIABP in VSTESTCD has triggered the application o
Read more

ODMv2: Renovating the ODM Standard

  ODM, CDISC's Operational Data Model , version 1.x will be 17 years old in October, making it a mature standard. ODM has come of age , and it's time for ODM to take on a bit more responsibility around here. Toward this end, a new XML Technologies development team has recently started work on ODMv2, a substantially updated version of ODM that breaks backwards compatibility with version 1.3.x to add a number of significant new features. This post highlights some areas of new development for ODMv2. As ODMv2 is still in the early stages of development, the scope of the project and specific features are subject to change. Among the more important new ODMv2 features will be a RESTful API that specifies standard methods of data and metadata exchange. The RESTful architecture uses specific URLs and the HTTP protocol to leverage pervasive, scalable web technologies to simplify data interchange. Lack of a common API for data exchange in clinical research has limited the available
Read more

What’s the difference between iSHARE and eSHARE?

Image
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. Interactive SHARE, or iSHARE , is the tool used by the CDISC standards development community for developing, governing, and publishing the standards. iSHARE is a cloud-based MDR configured for the CDISC standards that includes a number of standards management and development tools. Prior to accessing the tool, CDISC standards team members receive both on-line and interactive iSHARE training. Each standards development project works with the SHARE Metadata Curators to create and publish new CDISC standards. As new standards, and new versions of existing standards, are created iSHARE provid
Read more