CDASH SAE Draft Standard is now Available for Public Review and Comment – Comments due June 5, 2013
The draft CDASH-SAE document is now available for public review. The draft CDASH Serious Adverse Event Addendum to CDASH version 1.1 expands the current Adverse Event (AE) domain to include data elements for the capture of serious adverse event information in an SAE Form and, when indicated, will also allow for the generation of an E2B message for reporting an Individual Case Safety Report (ICSR) to Health Authorities.
We ask you to review the draft document and record your comments using the public review comment tool on the CDISC website. The link below will take you to the public commenting tool and a list of documents, please choose the CDASH-SAE doc from the list and begin to record your comments.
Click here for instructions on how to use the public review commenting tool.
Please return comments no later than June 5, 2013.
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 to CDISC members. 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.
CDISC Members can download the CDASH User Guide here:
CDASH Team Projects
• CDASH Version 1.2
The CDASH team is currently working towards the publication of CDASH Version 1.2. This version will include minor updates and clarifications. We anticipate that this new version will be available in Q4 2012.
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