News 
The CDISC European Interchange Conference, May 8th and 9th, 2019 in Amsterdam focused on the advancement of CDISC standards towards machine-readable metadata and compatibility with other standards.
I was very happy to learn that CDISC will soon be publishing a mapping table between its LAB test codes and LOINC (Logical Observation Identifiers Names and Codes), a well-known industry standard. The document is currently being reviewed by the FDA LOINC working group. And the CDISC codelist for measurement units has now been mapped to UCUM (Unified Code for Units of Measure); an Excel table is available for download. Both points enable CDISC to focus on standardizing data collection, data tabulation and data analysis datasets for clinical trials and for the submission of data to regulatory authorities, without reinventing the wheel in terms of nomenclature.
It is also encouraging to see that CDISC is closing the long-existing gaps and is starting to publish value-level metadata. Specifically, the CDISC controlled terminology team now provides Excel files with lists of measurement units to be used for each specific vital sign, subject characteristics, ECG results, etc. Thus, CDISC has essentially started publishing subsets of larger codelists and to attach such subsets to specific variables.
CDISC 360 Project
Peter Van Reusel, Chief Standards Officer of CDISC presented the CDISC 360 project, which aims to provide machine-readable links between data collection, data tabulation and data analysis datasets as well as analysis results datasets and specific endpoints. The vision is to support a “start from the objective” approach. For example, a data manager could use the CDISC Library, CDISC’s metadata repository, to search for endpoints that have already been standardized. Once the data manager selects an endpoint from the library, CDISC would allow them to download the definitions of everything that is needed to collect the necessary data, tabulate that data and analyze that data to prove or disprove this endpoint. And all that would be available as machine-readable metadata, ready to be imported into computer systems and to get started with a clinical trial with a strongly reduced effort for database programmers. XClinical is proud to participate in the CDISC 360 project and is contributing staff resources to make the project a success. At the same time, we are also learning about the newest features of the CDISC Library and its API, which we will integrate into our software products as soon as possible.
MDR Requirements for Study Build and Implications for the CDISC 360 Project
My presentation focused on “MDR requirements for study build and Implications for the CDISC 360 project”. Study builders need a basic set of features in a Metadata Repository (MDR) that is currently missing in the CDISC library. These features include search capabilities, unique identifiers, version control, value-level metadata and transformation-mapping between metadata, and downloads in a machine-readable format, preferably in the existing CDISC ODM.xml and Define.xml standard formats. These features are currently absent in the CDISC Library. Because study build is one of the use cases of the CDISC 360 project, these features should be added to the CDISC Library during the project. My presentation addressed the rationale behind these requirements and suggested possible ways forward. One mechanism to ensure easy machine-readable detection of any changes between different versions of CDISC standards in the library would be to introduce hashes across all the content attributes of every metadata element.
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