CDISC Shared Health And Clinical Research Electronic Library
This document summarizes the observations and findings of the CDISC Share Wiki pilot project and is organized into four sections: Method, Results, Answers to Primary Questions, Other Lessons Learned and Conclusions.
What is CDISC SHARE?
CDISC SHARE is a global, accessible, electronic library, which through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare.
In the first instance, CDISC SHARE will contain the existing CDISC standards, such as CDASH and SDTM, providing machine readable element (variables) within those standards. This will allow a range of applications used within organisations to automatically access those definitions.
However, the environment will also allow for the development of such definitions, in particular new therapeutic area domains along with the associated terminology. These new domains will also be available by the same electronic access mechanisms. 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 organisations to access the expansion of the CDASH and SDTM standards, as new therapeutic 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. 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 fashion across all of the standards as needed.
This will give users easier access – and 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 will be involved in developing CDISC SHARE?
CDISC will work with the CDISC teams and stakeholders to develop the content for CDISC SHARE. National Cancer Institute have offered to partner with CDISC to support the technology development for CDISC SHARE using their software. See the webinar link above for more details.
When will CDISC SHARE be ready?
We anticipate that CDISC SHARE will be ready for initial implementation in January 2011. 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 therapeutic area development, by leading a team or becoming a team member. You can contribute financial support by becoming a member or giving a donation. You could become one of our key collaborators. You could simply spread the word about this exciting development. Use CDISC SHARE when it is available and make sure that your partner companies do so too.
