Clinical Data Acquisition Standards Harmonization (CDASH)

New Draft CDASH v2.0 and CDASH Model v1.0 Now Available for Public Review – Comments Due 16 August 2016

 

The CDISC draft CDASH IG v2.0 and CDASH Model v1.0 are now available for public comment. For detailed information on the contents of this draft and to better understand how to interpret and apply the proposed rules, please read the "ReadMe for CDASH 2.0" first.

 To view the user guide: CDASH Model and CDASHIG

 You will need to log in or register for the CDISC Wiki to review the Read Me and provide comments.  

CDASH v1.1

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. 

 

Download CDASH v1.1

 

CDASH Serious Adverse Event (SAE) Supplement v1.0 

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.

 

Download CDASH SAE Supplement v1.0

 

CDASH-SAE Addendum Public Review Comments

 

CDASH User Guide (UG) v1.0

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.

 

Download CDASH UG v1.0

 

CDASH ODM.XML

The CDISC 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.  

 

Download CDASH ODM.XML

 

CDASH Data Definitions and CRF Examples

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.

 

Download CDASH Data Definitions and CRF Examples

 

Library of CDASH CRF Examples

A library of example CDASH CRFs has been created in different data collection systems, including paper examples.

 

Download Library of CDASH Example CRFs

 

Current CDASH Team Projects

 

CDASHIG v2.0 and CDASH Model v1.0

The CDASH Team is currently working on publishing CDASH Model v1.0 and CDASHIG v2.0, which will include major updates to the format and content of the CDASH standard. CDASHIG v2.0 will replace CDASH v1.1 and CDASH UG v1.0. Additionally, the Team has been collaborating on a number of related projects that include developing new domains and associated documents for medical devices and therapeutic area CRFs. 

Subscribe to RSS - Clinical Data Acquisition Standards Harmonization (CDASH)