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FAQ - SHARE

CDISC SHARE is a suite of tools and services, the cornerstone of which is a metadata repository, that supports the development, governance, publishing, and consumption of the CDISC standards in human and machine-readable formats. SHARE provides members with machine-readable electronic versions of CDISC standards and is a cornerstone of the CDISC roadmap.

 

Individual CDISC standards are developed in the CDISC Wiki and published to the CDISC website as PDF documents. These standards address discrete areas of the clinical and translational research, focusing on the most commonly used concepts that appear in most studies. PDF documents are easily read and understood by humans, but are not readily usable by machines, such as clinical research software systems. SHARE makes CDISC standards electronically accessible through a variety of file formats, including Excel, PDF, RDF and XML.

Exports in the form of different file formats are made available via the SHARE Exports page on the CDISC website. Prior to posting new content on this page, SHARE biocurators perform a semi-automated, two-step curation process for quality control and assurance of the CDISC metadata. SHARE includes the normative metadata from CDISC standards. Normative content is the "meat" of a standard, including classes, domains, variables, controlled terminologies, rules and other key metadata. Normative content from each standard is available on the SHARE Exports page. Published CDISC standards also contain informative content, such as examples and usage tips. Informative content is managed in the CDISC Wiki, which is part of the SHARE Ecosystem, but is not available at this time on the SHARE Exports page.

In addition to making CDISC standards easier to access and utilize, SHARE also provide a collaborative standards development environment for CDISC's diverse community of standards development teams. This environment includes a variety of SHARE tools to improve the quality, integration, reach and consistency of CDISC standards.

The SHARE metadata repository currently uses a licensed commercial software product in an externally hosted computing environment, both of which represent substantial costs to CDISC, which is a non-profit 501c3 organization. CDISC is currently evaluating more cost effective alternatives with the ultimate goal of making CDISC standards available through SHARE free to entire research community.

Accessing SHARE Content: All published CDISC standards are free and open PDF files to the entire research community (members and non-members) on the CDISC website, as has been our practice since our inception. Other electronic file types (e.g., Excel) are available to members and academics on the SHARE Exports page. Access to the SHARE Application Programming Interface (API), a RESTful web service, involves an additional cost to licensed users.

Creating Content within the SHARE Ecosystem: SHARE tools and services used by CDISC standards development teams such as the Wiki are also free for general community access and use per the terms of use of each tool.

CDISC is actively looking for strategic partnerships to help support the cost and maintenance of SHARE to enable free use of all SHARE tools, until that time, CDISC strives to ensure the benefits of SHARE can be realized at a fair and reasonable cost to users.

With the need to develop Therapeutic Area standards and the subsequent launch of the CFAST initiative, it quickly became evident that the process of defining Therapeutic Area data standards for a multitude of disease areas would require improved tools and capabilities that could not be fully met by the previous manual data standards development process. In particular, Therapeutic Areas need to capture patterns of data that may not currently exist in published domains, and match specific controlled terminologies for observations relevant to specific symptoms, diagnoses, tests and assessments. Moreover, many research concepts need to be reused across Therapeutic Area studies, and the breadth of information covered across these research areas may involve tens of thousands of unique concepts that need to be represented (often with customization) in protocols, CRFs, tabulations and analysis files. It quickly became clear that such an ambitious undertaking was unlikely to succeed unless a robust systems environment like SHARE could be made available.

The initial creation of CDISC Controlled Terminology occurs within Terminology teams. These terms are then packaged, curated, annotated, and maintained within the National Cancer Institute's Enterprise Vocabulary Services (NCI-EVS) system, a longstanding strategic partner of CDISC. NCI-EVS-curated CDISC Controlled Terminology extracts are then imported into SHARE.

SHARE consists of a central metadata repository, which is hosted on Amazon's EC2 cloud, and a variety of tools and services that are hosted by CDISC, including the Wiki, JIRA, and others.

Currently, external non-CDISC standards like SNOMED or LOINC are not loaded into SHARE. CDISC is focused on loading all the existing foundational and TA standards, as well as expanding its current base of standards metadata within the context of the existing standards (e.g. protocol, value level metadata). The SHARE team is actively extending the SHARE metamodel to include links to external standards such as SNOMED and LOINC for a future release.

No, eCRF vendor metadata is not part of the existing CDISC standards and will not be captured in SHARE. Vendor-specific eCRFs are considered an implementation of the standards. You will find metadata needed to create eCRFs from CDASH and in Therapeutic Areas standards that include CDASH metadata.

Yes. BRIDG 3.2 has been loaded into SHARE. Additionally, mappings to BRIDG are present in some SHARE Exports. The SHARE team is working to load BRIDG 4.1.1 into SHARE. BRIDG 4.1.1 includes molecular biology, biobanking and imaging concepts that were not present in release 3.2.

To learn more about BRIDG and access the latest release, or previous releases, please refer to the project's homepage.

Yes, there is a SHARE team that is open to volunteers able to meet the minimum participation requirements. Those interested in volunteering should use the volunteer form on the CDISC web site to sign up.

The CDISC SHARE project was initiated by members of the CDISC Board of Directors, CDISC leadership and volunteers in 2007. Early work began with a stakeholder analysis to define the initial proposed scope of SHARE. In 2009, a pilot project using Mayo Clinic’s LexGRID semantic wiki tool was conducted, which verified the potential value for SHARE and highlighted the need for a more controlled metadata repository environment with strong governance. Work proceeded after that to define detailed requirements and to begin organizing CDISC content so it would be SHARE-ready: well defined, mapped to BRIDG and ISO 21090 complex data types and clearly expressing relationships between collected CDASH elements and SDTM tabulations.

In 2012, CDISC entered into a partnership with the Critical Path Institute, FDA and TransCelerate BioPharma Inc. (TCB) to establish the CFAST Initiative and the Therapeutic Area Data Standards Program, which quickly recognized the need for a metadata repository as an essential infrastructure component to support the development of numerous Therapeutic Area standards. With TCB’s strong support, CDISC engaged in a formal evaluation process to identify solution providers with SHARE, resulting in the selection of a commercial metadata repository product in June 2013, followed thereafter by the public launch of SHARE.

TCB continues to be a financial supporter of the ongoing model development and hosting of the SHARE metadata repository.

A SHARE Steering Committee consisting of members of the academic, biopharmaceutical, clinical research organization (CRO), and information technology sectors was convened in 2015 to provide guidance and help set priorities for ongoing SHARE development activities.

When new content is posted to SHARE Exports for download, a notice is released on the CDISC Web Site. SHARE API adopters will also be able to query the web service at any time for a list of standards in the metadata repository.

Yes. Individual end users of the SHARE Exports must agree to basic licensing terms in our end user license agreement (EULA). SHARE API licensed end users must also abide by its EULA.

SHARE supports various download formats, such as ODM, Define-XML and flat file. Included in each are normative metadata such as classes, domains, variables, terminologies, etc. Informative content is not available in the metadata repository at this time. The SHARE team is working to create a central examples library and other tools for structure metadata capture for informative content within the Wiki.

No for now. Currently SHARE is utilized to create and distribute CDISC standards. Companies interested in extending the CDISC standards should subscribe to SHARE content, load that content into their own metadata repository instance, and then extend the standards as needed to include study level content.

Many companies have shared their desire to post their custom content to SHARE. This represents a substantial investment in SHARE technology enhancements, processes and new teams to review and curate the content to ensure high quality and consistency in the metadata repository. Substantial additional community discussion and new sources of support would be required to fulfill these requirements.

SHARE Export files can be readily utilized by data managers, biostatisticians, data standards experts and other technical staff. The SHARE API is useful for system architects, programmers, biostatisticians, bioinformaticians and other similar research IT staff.

To create standards-compliant databases and applications, CDISC members historically had to review long PDF standards documents and hand extract metadata from their classes, domains and variables. These metadata then had to be processed for inclusion in each electronic system. SHARE’s electronic standards frees these standards from the PDF. By providing the variables and other CDISC standards metadata in a machine-readable format, you no longer have to hand extract standards for your databases, applications, reports or other electronic systems, including your organization’s own metadata repository. This saves substantial time and money, while increasing quality and consistency.

SHARE helps users find, understand and use rich metadata and controlled terminologies relevant to clinical and translational studies. It also helps improve integration and traceability of clinical data from protocol through analysis through implementation of CDISC's interconnected, non-redundant standards. Use of CDISC standards through SHARE also facilitates aggregation of data to gain new insights to inform the research process, and improves interoperability with healthcare by aligning research concepts with external healthcare concepts. SHARE helps CDISC realize the promise of defining data standards once so data can be reused many times for multiple research purposes.

 

 

SHARE's metamodel allows us to specify how content within a standard is related and how different standards relate to one another. SHARE features a CDISC metamodel that implements the international ISO/IEC 11179 standard for metadata registries. We use it to define and register normative standards content such as variables or domains from CDISC standards, such as SDTM, CDASH, Controlled Terminology, etc.

To access SHARE Exports, please log in to your account on the CDISC web site and navigate to the Members Only area in the upper right-hand corner. SHARE Exports is the first selection from the drop-down menu. If you do not have an account, please complete the information on our Create an Account page.

To access the SHARE API, please visit the SHARE API Early Adopter Program page.