munging metadata

Along with JIRA and the Confluence Wiki, CDISC has added the Atlassian Bitbucket distributed version control system to our online toolset. CDISC finally has a Git-based version control system, and several projects have already started using it. In cases where a standard is under development, the repository may be private to the team and not accessible by others. However, I anticipate a growing number of publicly accessible CDISC Bitbucket projects. The XML Technologies and SHARE teams are using Bitbucket and will have publicly accessible projects. Trace-XML is one such project. More on this in an upcoming post. You can find Bitbucket from the CDISC Wiki or JIRA by selecting the drop-down menu in the upper left-hand corner of either application, as shown in the graphic below. If you haven't used Git or Bitbucket before there are numerous online tutorials to get you started. Most code developed in a project of mine will have a repository on Bitbucket. That said, there are times...

If you're wondering where the XML standards like Define-XML went on the CDISC website, they've moved. They're now located under Standards/Transport . If you go to the transport page  you can select from a fairly extensive menu of transport standards. There are a few transport options located elsewhere, such as Lab  and the Analysis Results Metadata  Define-XML extension. Our broad list of XML standards is in the process of welcoming a new version of Define-XML to the family. This new version of Define-XML, v2.1, will almost certainly be listed in the standards catalogs of regulatory authorities at some point, so all of you working on regulatory submissions should find this update interesting. There are a couple weeks left in the Public Review period (it ends on May 5th) so there's still time to add your comments. You can find the Define-XML v2.1 Public Review package  along with instruction for adding JIRA comments on the CDISC wiki . While Define-XML v2.1 is a m...

As the CDISC XML Technologies team finalizes Define-XML v2.1 for internal review an old debate has re-surfaced: how much should the Define-XML specification focus on the regulatory submissions use case versus providing a more general specification that works for a broader set of use cases. As a standard that provides metadata to describe tabular datasets, Define-XML can be used to describe legacy datasets as well as datasets included for submissions. Define-XML has also been used as a specification for datasets. However, Define-XML became the most widely implemented ODM-XML based standard due its role as a required element of regulatory submissions. The importance of ensuring that Define-XML files included in a submission are complete and accurate makes a compelling case for adding rules that specifically target this use case at the risk of reducing its usefulness in other contexts. Having recently participated in the September HL7 FHIR connectathon in Baltimore, MD it strikes me ...

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...

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...

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...