SHARE 2015 Q4 Technical Update

The SHARE API Pilot continues to make progress. A draft specification is being reviewed and a test server is running the API as currently specified. The pilot team will finalize the draft specification and spend the rest of the year testing and developing interfaces to the API. The SHARE team will also make use of the API to enhance tools in the SHARE ecosystem by making it easier for them to consume SHARE metadata. The SHARE API will be moved into production during Q2 of 2016.

A few last development details are being cleaned up for the SHARE RDF export, and then we'll work to generate a test export for the community to review. The initial exports will include SDTM, CDASH, and Controlled Terminology. The RDF content will be posted to eSHARE, and will also be available for consumption via the API once it has been moved into production.

The Biomedical Concept (BC) development tools have seen a number of upgrades this year. These tools are currently being used by the Collaborative Curation Initiative (CCI) to develop the BCs for the Prostate Cancer TA project. We're currently working to update the BC model within the SHARE MDR. Some have expressed an interested in gaining early access to this content via eSHARE and the API. Given BCs usefulness in supporting process automation and the generation of study artifacts, software vendors are keenly interested in the continued development of this content in 2016.

Over the course of 2015 eSHARE access has been expanded beyond Platinum members to include Gold members and academic researchers. For those interested in learning more about eSHARE, the webinar we delivered for the Gold member rollout is a useful place to start https://www.youtube.com/watch?v=NCjnnaaS4H4&feature=youtu.be. New content is continually being posted to eSHARE as it becomes available. Earlier this year the first version of ADaM 2.1 was posted, and an updated version that includes new input from the ADaM team is expected soon. New TAUG content continues to be posted as it becomes available. In December we plan to post some new catalogs and listings, to include the Domain Catalog. A BRIDG alignment report generated as part of the BC development will be posted for review. Finally, we plan to post an SDTM to CodeList spreadsheet that maps Controlled Terminology CodeLists to SDTM variables by the end of the year.

A draft position statement was created by the SHARE team with input from many stakeholders. Please add your comments to the wiki page: http://wiki.cdisc.org/display/SHARE/LOINC+Discussion%3A+3+Nov+2015+-+SHARE+Telecon.

Protocol standards were not available for loading into SHARE during 2015, but we plan to begin loading protocol objectives and endpoints into SHARE during 2016 Q1.  Given all the activity around the development of a protocol standard, the SHARE team plans to work with the CDISC terminology team and the NCI EVS to create a protocol vocabulary that can be loaded into SHARE. Before the end of the year, a proof-of-concept using elements of protocol in an end-to-end standards representation is planned.

Structured validation rules are currently under development by the SDS and ADaM teams. SHARE will use the wiki templates to develop rules in support of the TA standards using this format until a rule formalism is agreed upon. Once the formalism has been selected, the SHARE MDR model will be updated and rules in this format will be loaded. The new rule format will be piloted in 2016.

A wiki-based example repository is currently available. This repository will facilitate example re-use. The ability to re-use examples will be leveraged in support of the TA standards development projects. Before the end of the year, we will run a proof-of-concept that loads TAUG examples into the SHARE MDR.

Early in 2015 the CDASH-to-SDTM mapping was generated for eSHARE as part of the end-to-end standards work. By the end of the year we will post a similar SDTM-to-ADaM carry over variables file for review. BCs will play a key role in the development of end-to-end standards in 2016, and protocol will be added prior to the end of 2016.

Finally, the SHARE team is working as a part of the Prostate Cancer TA standards project to develop new tools in support of developing TA standards. Starting with the Prostate Cancer project, SHARE tools will be used to generate a draft TA Specification document containing the normative standards. This is one of the clearest examples of SHARE supporting an expedited TA standards development process. SHARE tools will also contribute to the TA User Guides which include non-normative content such as examples from the SHARE example repository. The Prostate Cancer TA standard project represents an innovative first step towards using automation to drive a significant portion of the standards development effort, and one that we will build upon in future projects.

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