CDASH establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.
CDASH 2.0 comprises the CDASHIG v2.0, the CDASH Model v1.0, and CDASHIG metadata tables to define basic standards for the collection of clinical trial data and how to implement the standard for specific case report forms.
The structure of CDASHIG v2.0 is a complete reorganization of the CDASH standard that mirrors the structure of the SDTMIG with specification tables, assumptions and examples. CDASHIG v2.0 is also a more complete standards package than before, including the implementation guide, metadata tables, multiple use cases of example CRFs and the CDASH Model v1.0 that is aligned with SDTM v1.4.
This release updates all previously published domains and adds several new domains that are aligned with SDTMIG v3.2, and incorporates examples and mapping information that were previously found in the CDASH User Guide (CDASHUG) and the CDASH CRF Library.
The CDASH Model v1.0 is a new standard that describes the root metadata for data collection variables and questions, enabling implementers to create new data collection fields and forms that conform to CDASH principles and that are harmonized with SDTM v1.4. The Model also includes an explanation of how to implement horizontal data collection when the SDTM target is in a vertical structure, such as a Findings class domain.
CDASHIG v2.0 and CDASH Model v1.0 metadata are available in the CDISC SHARE Exports section of the CDISC Members Only Area of our web site. If you are an employee of a CDISC Member Organization, you can access this metadata by logging into your account and visiting the Members Only Area in the upper right-hand corner of the web site.
The CDASH model can help implementers quickly create sponsor-defined (custom) domains for data collection that will map easily to SDTM-conformant custom domains. Another key attribute of the CDASH Model is that the root Question Text and Prompt attributes provide implementers with much more flexibility than before in wording the questions on the CRF.
CDASH v2.0 is published in HTML format, which expedites delivery of the standard and is viewable in any standard browser. HTML format allows users to search for keywords within the page, and bookmark the information in a browser. Implementers can also print the page, or export the information into other formats (e.g., PDF). To save a copy of the HTML publication on your desktop to access the document offline, press CTRL-S (PC) or COMMAND-S (Mac) on your keyboard.
CDASH UG v1.0 provides implementation examples, including CDASH to SDTM mappings and other helpful implementation information, and should be used as a supplement to the CDASH v1.1 standard.
Developed with participation from organizations in all three ICH (International Conference on Harmonization) regions (US, Europe and Japan), CDASH v1.1 describes the recommended data collection fields for 16 domains, including demographics, adverse events, and other domains common to most therapeutic areas and clinical research phases. Additionally, CDASH v1.1 includes implementation guidelines, best practice recommendations, regulatory references.
This supplement expands the AE domain in CDASH to include additional data elements to capture information in an SAE form, facilitating Sponsor generation of an E2B message for electronic reporting of an Individual Case Safety Report (ICSR) to regulatory authorities.
The Operational Data Model (ODM) is a vendor neutral, platform-independent XML format for exchanging and archiving research data. CDASH-ODM XML files are an implementation of ODM, providing examples of basic case report form CDASH content in ODM-XML format. The XML may require modification to apply to a particular study or to implement in a particular database system or application.
These PDF files provide a starting point for creating CDASH CRFs and include the data definitions and CRF examples from the ODM-XML CDASH files.
A library of example CDASH CRFs has been created in different data collection systems, including paper examples.