CDISC SHARE – Project Overview Document is Now Available
The CDISC SHARE Project Overview Document is intended as summary to orient CDISC members to the project background and progress made to date. This document was compiled by the SHARE project team and describes the project, the organization, stakeholders and provides a high-level description of the SHARE-based therapeutic area standards development process that is currently under development to support semantic interoperability. The document also describes the work of the five CDISC SHARE sub-teams, followed by a brief list of high-level software requirements, a section that describes how SHARE content has been developed to date, a summary of governance procedures, and finally a reference section that points to the various documents generated to support the project.
THE SHARE Project Overview document can be downloaded here.
CDISC SHARE RFI Now Available
CDISC is issuing a Request for Information (RFI) to identify potential collaborators for its proposed SHARE Global Metadata Repository. SHARE is envisioned to eventually house comprehensive, well defined metadata and value sets for all CDISC standards from protocol through analysis, linking research concepts to healthcare, and will become the fundamental technology platform for developing, maintaining and accessing CDISC standards in the future.
This RFI describes in broad terms the scope and major functions of SHARE, and asks respondents to reply to a short list of questions to describe their organization, desired role and suggested ideas and potential product solutions to support the SHARE initiative.
If you are interested in replying to the RFI, please send an email with your organization name, contact person, phone and email to SHARE@cdisc.org. All responses are due by Thursday, 20 September 2012.
CDISC Shared Health And Clinical Research Electronic Library
What is CDISC SHARE?
CDISC SHARE is a global, accessible electronic library, which through advanced technology, enables standardized data element definitions and richer metadata that can be used in software applications and research studies to improve biomedical research and its link with healthcare. SHARE metadata is envisioned to help find, understand and use clinical metadata efficiently.
In its first phase, CDISC SHARE will contain the CDISC standards CDASH and SDTM, providing machine readable elements (variables) within those standards. This will allow a range of software applications used within organizations to automatically access those definitions.
Later phases will include the remaining CDISC standards and also allow for the development of new therapeutic area domains and definitions along with the associated terminology.
CDISC intends to partner with other organizations to ensure that the SHARE content supports the vision of ‘enter once for multiple purposes’, including biomedical research and related areas such as public health, quality and safety.
Why develop CDISC SHARE?
CDISC SHARE will provide for easier access to the existing CDISC standards and any subsequent development to those standards. In particular, it will allow organizations to access the expansion of the CDASH and SDTM standards, as new therapeutic area domains are developed. By having this managed centrally and available electronically, it will decrease costs for those using the standards.
The CDISC SHARE environment will also provide for a consistent approach to standards definition and metadata development. This will in turn increase the quality of the standards by allowing for unambiguous definitions to be defined once but used many times in a consistent and integrated fashion across all of the standards as needed.
This will give users easier access – and software applications machine readable access – to the one “gold” data standard that will facilitate greater data re-use and aggregation. In time the definitions will be linked to those used within healthcare to permit the alignment of Clinical Research and Healthcare.
Who is involved in developing CDISC SHARE?
CDISC is working with the CDISC teams and stakeholders to develop the content for CDISC SHARE. CDISC is currently looking for partners to support the technology development for CDISC SHARE.
When will CDISC SHARE be ready?
We anticipate that CDISC SHARE will be ready for initial implementation in 2012. Updates to this projected timeline will be posted as they become available.
How do I get involved with CDISC SHARE?
You can volunteer to contribute content by becoming involved with one of the CDISC SHARE teams: Content, Governance, or User Interface. You can contribute financial support by becoming a member or giving a donation. You could become one of our key collaborators. Use CDISC SHARE when it is available and make sure that your partner companies do so too.