Version 1.1 of the Clinical Data Acquisition Standards Harmonization (CDASH) was developed with participation from organizations in all three ICH regions (US, Europe and Japan). The standard describes the basic recommended data collection fields for 18 domains; including demographics, adverse events, and other common domains that are common to most therapeutic areas and phases of clinical research. In addition, CDASH V 1.1 includes implementation guidelines and best practice recommendations, regulatory references and other information on the CDASH project.
This supplement expands the Adverse Event (AE) domain in the current CDASH standard to include additional data elements for the capture of serious adverse event information in an SAE form to facilitates Sponsor generation of an E2B message for electronic reporting of an Individual Case Safety Report (ICSR) to Health Authorities.
CDISC CDASH-SAE Addendum Public Review Comments
The CDASH User Guide (CDASH UG) provides CDASH implementation examples, including CDASH to SDTM mappings, CDASH ODM files and a library of example CRFs that have been created in several different data collection systems, including paper examples. The CDASH team plans to update the CDASH UG with additional examples as they become available.
Zip file with User Guide and all associated files
The CDISC Operational Data Model (ODM) is a vendor neutral, platform-independent XML format for interchange and archive of research data.
The CDASH-ODM XML files are an implementation of ODM that provides examples of basic case report form (CDASH) content in ODM-XML format. The XML may require modification to be applicable for a particular study or to be implementable in a particular database system or application.
These PDF files include the data definitions and CRF examples that have been created from the ODM-XML CDASH files. The primary purpose of these examples is to provide a starting point for the creation of CDASH CRFs.
A library of example CDASH CRFs has been created in several different data collection systems, including paper examples. The CDASH team plans to update the CDASH UG Example CRF library with additional examples as they become available.
If your organization would like to submit example CRFs to the User Guide team to be included in the CDASH CRF Examples library, please send a representation (e.g., pdf, screen shot) of the CRF, a description of the use case you are addressing, and the name of the EDC or other system in which you created the example CRF to Shannon Labout.
All submitted example CRFs should be de-identified (i.e., remove the name of your company, name of your investigational product, etc, from the CRF example). The CDASH team will review all examples submitted. Conformant examples of CRFs will be added to the library, provided permission to publish the example is given by the EDC or other vendor in whose system the example is represented
Current CDASH Team Projects
•CDASH Version 2
The CDASH team is currently working towards the publication of CDASH Version 2.0. This version will include minor updates and clarifications. We anticipate that this new version will be available in late 2014.
In addition, the CDASH Team has been working on a number of related and collaborative projects that include the development of new domains and associated documents for medical devices and therapeutic area CRFs. Following are short summaries about these CDISC projects:
•CDISC Device Standard
The CDISC Device team is comprised of members from the CDASH and SDS team and is working to develop the basic collection fields and the submission variables and mappings to support a majority of device studies. The Device team recently published draft SDTM constructs for public comment. Work on the collection aspects will commence as soon as the submission elements are agreed.
•CDISC Therapeutic Area CRFs
The CDASH team is collaborating with other CDISC teams to develop therapeutic area (TA) specific CRFs to be used together with the safety CRFs described in the CDASH standard. Draft TA specific CRFs will be released for public review according to the CDISC consensus process.
The CDASH team also supports the development and review of a REDCap CDASH CRF library.
•CDASH User Guide team
The CDASH User Guide team will continue to add example CRFs and other implementation tools to the CDASH User Guide.