CDASH Serious Adverse Event (SAE) Supplement v 1.0 is Now Available
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. This supplement also facilitates Sponsor generation of an E2B message for electronic reporting of an Individual Case Safety Report (ICSR) to Health Authorities.
CDASH Version 1.1 was developed via CDISC’s consensus-based standards development process (see COP-001), which included comments from organizations in all three ICH regions (US, Europe and Japan). The standard describes the basic recommended data collection fields for 18 domains; these include common header fields, demographic, adverse events, and other safety domains that are common to all 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.
Download CDASH here:
CDASH User Guide
The CDASH User Guide (CDASH UG) is now available. The CDISC 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.
Download the CDASH User Guide here:
CDASH User Guide and Associated Implementation Tools
Download all of the files in this page here:
Zip file with all User Guide and associated files
CDASH User Guide
Version 1 of the CDASH User Guide for the Clinical Data Acquisition Standards Harmonization V1.1 (CDASH UG V1-1.1) is now available. The CDISC UG provides CDASH implementation examples, including CDASH to SDTM mappings.
Download the CDASH User Guide here:
CDASH ODM.xml, Data Definitions and CRF Examples
The Operational Data Model (ODM) is a vendor neutral, platform-independent format for interchange and archive of research data. Click here for more information about ODM.
The CDASH-ODM file provided below is an implementation of ODM that provides examples of basic case report form (CDASH) content in XML. The XML may require modification to be applicable for a particular study or to be implementable in a particular database system.
The PDF file provided below includes the data definitions and CRF examples that have been created from the ODM XML. The primary purpose of these examples is to provide a starting point for the creation of CDASH CRFs.
Download the CDASH ODM file and example CRFs here:
Library of CRF Examples
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.
Download the CDASH CRF Example Library here:
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.
CDASH Team Projects
• CDASH Version 2.0
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 Q1 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.
• CDASH Serious Adverse Event Domain
This CDASH-E2B sub team is working to identify and describe the E2B basic data fields that are collected from investigative sites. This new Serious Event domain is intended to reduce the need for separate SAE reporting processes and the inevitable duplication of data collection that occurs between the SAE and clinical databases. The draft standard will be released for public review according to the CDISC consensus process.
• REDCap CDASH-CRFs
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.
Join us on the CDASH Team!
If you would like to volunteer on the CDASH team, follow this link to let us know how you can help. See below for more information about team participation.
CDASH Team Participation:
CDASH Team members should be experienced/familiar with the standard and/or knowledgeable about the collection of clinical data in the research area either from the investigative site or the CRO/Sponsor perspective. Team members are expected to contribute meaningfully to the ongoing development of the standard.
As a CDASH Team member you would be committing to:
• Attend scheduled teleconferences and actively participate in the discussions
• Actively review CDASH documents in development and provide written and verbal feedback
• Actively review internal and external review comments with the CDASH Team
• Participate in the development of new and update of existing CDASH documents, including helping to identify new domains and aligning development with other standards teams
As a CDASH Team member you would also have the opportunity to do one or more of the following:
• Lead sub-teams of volunteers to accomplish time-bound goals
• Contribute to the development of training materials
• Attend periodic face-to-face CDASH Team meetings to participate in development and review activities
• Attend periodic cross-team CDISC meetings to work with other standards teams
• Liaise with other standards development teams
Other Opportunities for Participation:
Should you be unable to meet the level of commitment required of team membership, the CDASH team still needs you!
The other main venues for participation in the CDASH project as a non-Team member are:
• Reviewing draft standards and documents during public review and providing written feedback
• Implementers of the CDASH standard are encouraged to send feedback to Katie Carothers or Rhonda Facile. Information on implementation experience will be used to continue to improve the CDASH standard and other related standards.
• Encouraging your company to become a CDISC member
• Participating in the CDASH discussions on the CDISC website
• Participating in Linked In and other forum discussions to help clarify and refine the standards & implementation guides
• Attend CDISC events (e.g., Interchanges, webinars on CDASH)
Please follow this link to let us know what you would like to do and we will get you set up with what you need to participate.
Standards in Production
**New** Clinical Data Acquisition Standards Harmonization (CDASH) Standard version 1.1 | Non Members