Welcome to SHARE, the cloud-based, global repository of curated CDISC clinical and translational research standards and semantics. As a metadata repository (MDR), SHARE is used to create, reuse and manage CDISC standards’ metadata to improve the quality, reusability and integration across CDISC standards and controlled terminologies. With SHARE, standards are no longer trapped in PDFs, where they must be extracted to use in your databases, software and systems. SHARE contains metadata content from models and implementation guides from classes, domains, variables, etc. that tell what each is, and how to comply with the standard when implementing it in your organization
Why Use SHARE?
SHARE is beneficial to all organizations engaged in regulated, pre-clinical and clinical research as it:
- Saves time. Through SHARE, standards including SDTM, SDTMIG, SEND, SENDIG, CDASH, Therapeutic Area Standards, Controlled Terminologies and IG Supplements for Medical Devices, Pharmacogenomics/genetics and QRS are no longer trapped in PDFs, where they must be extracted for use in your databases, software and systems.
- Helps ensure compliance. SHARE provides access to multiple file types of CDISC standards required for new submissions to FDA and PMDA.
- Facilitates impact assessments. SHARE allows the creation of “Diff files,” which specify what has changed from one version of a standard to the next, facilitating analysis of how your reports and data management systems will be affected when when your organization adopts the latest version of a CDISC standard.
- Interconnects standards. Using SHARE, you can easily interrogate across CDISC standards to determine where the same variable is used in two or more standards. These points of interconnected metadata also link data collected during the course of a protocol, improving data quality with consistent metadata reuse.
- Supports end-to-end standards. CDISC standards cover the complete clinical research lifecycle from electronic health record and protocol design through statistical planning, case report form design, data collection and tabulation, analysis and reporting. Implementing these interconnected standards in your systems from the earliest phase of a trial to its conclusion allows you to trace the same data element throughout the trial lifecycle.
These benefits exist for you regardless of whether your organization has a metadata repository or not. If your organization has a metadata repository, exports from SHARE can be imported through the SHARE Application Programming Interface (API) to manage all CDISC standards in your systems (e.g., as a CDISC library in your metadata repository). These standards can then be deployed and synchronized across multiple systems in your organization at once.
If your organization has a metadata repository, exports from SHARE can be imported through the SHARE API as a CDISC library. End users can use SHARE API-aware MDR products to automatically update their repositories with the latest CDISC standards content. These standards can then be deployed and synchronized across multiple systems in your organization at once.
The Scope of This Tutorial
Employees of CDISC Member organizations can download CDISC standards in multiple file types (e.g., Excel, XML, RDF, CSV) from the Members Only Area of the CDISC website. In this tutorial, you will learn about the types of files available from SHARE on the CDISC website and how you can use them to assess standards, implement them in your databases, and determine the impact of standards content that has changed from one release to the next. Because each organization’s data management and reporting systems are unique, specific guidance on how to precisely implement SHARE’s standards in your organization should be determined at each organization accordingly.
This tutorial applies to SHARE exports only and assumes no knowledge of programming languages such as Java, Python, C dialects or Perl. If you prefer to write a program to access content directly from the metadata repository as part of licensed API use, please see our SHARE for Technical Implementers tutorial.
Required Skills & Software Programs:
- Knowledge of CDISC standards and how they are implemented in your organization
- A tool to open SHARE files such as text editors, spreadsheet packages or database IDEs (Integrated Development Environments)
- Experience with relational databases and a database language such as SQL*
*For RDF downloads, graph databases and SPARQL are required, which are out of scope for this document.
An Overview of SHARE Exports
All files are versioned, as indicated in the file name. When downloading XML, note that for some browsers you must specify, usually via a right-click command option, that you would like to download, and not merely view the XML in your web browser.
Final published standards are available for download alongside content pending final curation. In addition to being available for download via SHARE from the CDISC website, CDISC Controlled Terminology is maintained and distributed by the NCI EVS, alongside many other controlled terminologies, codesets and other semantic information.
Using SHARE Exports from the CDISC Website
On the CDISC website, navigate to Membership on the menu bar and select Member Login from the dropdown.
If your organization is a member of CDISC and you already have created an account, enter your username (email address) and password to access content in the Members Only Area.
If you do not have a CDISC account and your organization is a CDISC member, you can create an account and complete the requested information using your organizational email address as that is how the system can verifies membership.
Once logged in, select SHARE Exports from the Members Only drop down.
From here you can review the SHARE standards catalog to find the model(s), implementation guide(s), terminology package(s) or Diff file(s) of your choice. Older standards no longer supported by CDISC, which have been superseded by newer content versions are available only via PDF.
After each standard is released, it must undergo curation for inclusion within SHARE. As such, there is a delay between a new standard’s availability in PDF form and in various file formats in SHARE.
If you cannot find any standard or a desired Diff file, please contact CDISC for assistance.
Using SHARE Exports
In the SHARE Standards Catalog, download the Excel versions of SDTM 1.4 (IG 3.2), SDTM + CT bundle, and the SDTM IG 3.2 – 3.1.3 Diff File.
Using Implementation Guide Files
Each Implementation Guide’s file contains metadata for the classes, domains, variables, controlled terminologies, CDISC notes and additional features. Each row in the file contains metadata on a single asset (e.g., variable or domain).
Why are these, and their associated standard specification files, useful? These files can be used as a reference, to support creation of database tables or reports where domains and variables are hardcoded (e.g., specified as columns in a table), and to provide the metadata needed to update your tables when domains and variables are stored there for metadata-driven systems.
How can I use them in my environment? These files are useful as-is for quick assessments or as reference tools. They are more powerful when used in combination with other metadata from your organization. Many database tools exist for data managers, and most of these have a data import wizard to import files into existing tables or into newly created tables. You may use this feature or other methods to import copies of the SHARE model and implementation guide standards into a database for which you have appropriate privileges. You may then run reports against this table and even query other database schemata to which you have privileges by using domain and variable codes or other identifiers that your organization has implemented.
To use SHARE content to update CDISC standards’ metadata in your organizations’ production systems, you should work closely with your IT staff as needed. Always create a plan to determine how to transform the content from SHARE to match the structures required by your systems or how to update any hardcoded values in your systems to match the latest standards release. These changes should be accompanied by a regression and user acceptance testing interval per your IT policies.
Using Controlled Terminology Packages
Open the SDTM Controlled Terminology package file. Note that you can download terminologies as separate packages or bundled with the model and implementation guide. Controlled terminology files contain metadata describing new and updated terms, their National Cancer Institute (NCI) Identifier Code, and CDISC Codelist.
These terms represent CDISC standard semantics and can be used when designing case report forms (CRFs), for example. Using terminology packages, you can link controlled terminologies to their Foundational Standard variable, NCI C-code, Codelist and other information. This will provide full information on the Foundational Standard.
Why are these and their associated standard specification files useful? These files provide the semantics, or meanings, of CDISC standards. By also providing NCI C-codes, these files enable you to cross-reference a CDISC Controlled Term with a wealth of other information in the NCIthesaurus. You can use these packages as a reference and to perform impact assessments where new terms have been added or changes have been made to existing terms to define which systems in your organization will be affected and to what extent.
How can I use them in my environment? These files can also be reviewed on your desktop or imported into your database for assessment, querying and additional needs as before.
Using Diff Files
Open the SDTM IG 3.2 – 3.1.3 Diff File Excel in the spreadsheet software of your choice. This file provides information on new domains and variables, updates to existing content and content that has been deprecated in the latest release of a standard.
These files can be used to determine what changes, if any, must occur in your organization’s systems when adopting a new version of a given CDISC standard. Impact can be as minor as adding new metadata if your systems are metadata-driven or can include changes to your organization’s software (e.g., updating hard-coded variables as they are updated, or removed in newer versions of a standard). Using Diff files expedites and facilitates determining the costs associated with the up-versioning, such as with software development and testing, creating or amending new reports, training on new or changed semantic definitions, and other real or indirect costs.
Each row of a Diff file contains information on only one addition, removal or update. Domain and variable codes are specified for each row, except where a change has occurred at a domain-level. No variable is specified for domain-level changes.
Entirely new domains and variables are denoted by the value “Add” in the Action column. Added variables include new attribute, whereas updates include both the previous attribute and its new, updated metadata. Metadata in the file are ordered by the variable short name.
Changes in any controlled terminologies are indicated with parentheses.
How can I use them in my environment? By uploading Diff Files to a database, you can link these changes to variables within your own systems through querying across the Diff File table and tables in other systems’ databases that have implemented CDISC standards. Use the domain and variable codes or other identifiers, as before. If you are querying across different platforms such as Excel spreadsheets, Access databases, relational databases or non-relational databases, you must have a tool that supports multiple simultaneous database connections and various types of SQL and/or SPARQL syntax.
Using Therapeutic Area Standards
Therapeutic Area (TA) standards describe how CDISC Foundation Standards and Controlled Terminologies can be applied to specific TAs and their indications. TA standards utilize Foundational Standards’ domains and variables, and can contain their own unique assets. Each TA standard in SHARE is available on the CDISC website as a .zip file that contains multiple Excel spreadsheets, including the TA Specification and its User Guide, at a minimum.
Why are these files useful? Each file contains TA and indication-specific domains and variables, as well as domains and variables linked from Foundational Standards. These linkages are key for implementing end-to-end standards. Many .zip files also include CDASH mappings. The Excel file maps the TA metadata to that from CDASH, which expedites building electronic case report forms (eCRFs). These metadata include labels, CRF completion instructions, information for sponsors, and Controlled Terminology codelists for enumerated lists (i.e., radio buttons, check boxes or drop down lists in an eCRF). These items will support creating eCRFs based off of a TA’s CDASH bindings.
How can I use them in my environment? These files can also be reviewed on your desktop, used to design and implement standardized eCRFs or imported into your database for assessment, querying and other needs as before. If your organization has metadata-driven eCRFs, you may also transform a TA’s CDASH metadata and import it into the appropriate table(s) to automatically generate the form. To map TAs’ CDASH mappings to specific term(s), import the TA CDASH file to a new table in your database, as before. Query the TA CDASH file, joining it to the Controlled Terminology table using the Codelist Short Name and CT release date.