munging metadata

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 cr...

When people point to flaws in SDTM, they typically appear to me as gaps in the existing standard. In general, CDISC started defining standards by focusing on the basic structural metadata (e.g. domains, variables, code lists). This makes sense because this structural metadata is fundamentally useful, and relatively easy to understand and create. As the industry’s use of the standards has increased, so has the demand for standards that can be implemented more consistently and easily, as well as standards that are more computable. The limitations in the current standards are gaps, and addressing these gaps represents a natural evolution for the CDISC standards. As noted in my previous post “What’s in a SHARE Value Level Metadata Library?” CDISC does not currently contain Value Level Metadata (VLM) content, and this content represents a lot of new metadata. VLM is a gap in the existing standards. How do we know what variables are impacted by a specific –TESTCD? Much of that informati...

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 inst...

During May and June the SHARE team has been 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 towards 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. The SHARE Metadata Curators continue their work with the foundational standards teams to lo...

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...

Since the R1 library was moved into production at the end of January, the SHARE team has been hard at work on the R2 deliverables. Broadly speaking, R2 is focused around three main themes: (1) loading the remaining foundational standards, (2) publishing machine-readable standards to eSHARE, and (3) designing a solution for research concepts. On the first theme the SHARE curators are working with the SDS team to load SDTMIG 3.1.3, in addition to working on the import of SDTM IG 3.2. The curators are also working on the first controlled terminology update with the March release. On the second theme the team has implemented features to provide machine-readable standards exports, and has been testing these. The new CDISC web site will host this content for subscribers, and will be available for use this summer. Finally, on the third theme the team has been working on the requirements and a solution alternative for research concepts. A prototype of this solution will be implemente...

SHARE is no longer merely a vision, idea, or plan. After nearly 6 months of implementation work SHARE R1, our first production library, has been completed. Woot woot! This is a major milestone. We've taken the first step on a long journey towards realizing the vision of transforming the CDISC standards into an end-to-end, interoperable set of metadata all available in a machine-readable format. Both SDTM 1.2 (IG 3.1.2) and CDASH 1.1 have both been loaded into the production SHARE Library. Using SHARE R1 we will load SDTM 1.3 (IG 3.1.3) and SDTM 1.4 (IG 3.2) in the coming weeks. Although the CDISC Controlled Terminology development and governance processes will remain unchanged, we will continue to load each newly released terminology package into SHARE. BRIDG 3.2 and the ISO 20190 data types have also been loaded into the R1 library. The theme for R1 was Machine-Readable Standards. The SHARE Team plans to publish metadata from SHARE for subscribers to download by the end o...

Metadata Curator Wanted Being a metadata curator means most won’t exactly understand what you do. You can certainly forget about explaining your job to your mom.  Traditionally, curators have managed collections of old stuff, like what you might find in a museum.  In today’s world of informatics and big data, however, metadata curators play an essential role in enabling metadata driven automation and semantic interoperability. At CDISC we are implementing the SHARE metadata repository  to manage the latest standards metadata, as well as the older stuff. The SHARE metadata curators will play a critical role in defining and administrating the processes and policies for governing the metadata that will become the CDISC standards. They will help to lead the CDISC community towards new ways of standards development.  In this capacity, the metadata curator must be a passionate advocate for clinical research data standards, a strong communicator, as well as an energ...

SHARE wasn't only the theme of this year’s International Interchange, it was also a launch of sorts. CDISC has certainly talked about SHARE at past Interchanges, but this year’s dialogue had a different quality to it. This was largely driven by the fact that the wrappers were taken off the SHARE software, and attendees actually got a preview of what’s coming. We’re still talking about the vision for SHARE, maybe more than ever, but we’re also talking specific features and functions, as well as when we’ll begin using the application. During the SHARE session on Thursday the SHARE Road Map was presented, the version of SHARE currently under development was demonstrated, and we saw how SHARE and CFAST fit together.  The release of SHARE R1 is planned for the first quarter of 2014. After initiating the project in 2007, and following a longish gestation period, the implementation is on target to deliver in a period of just under 6 months. We have a long way to go to fully realize t...