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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 available to CDISC members. The CDISC UG provides CDASH implementation examples, including CDASH to SDTM mappings.

 

Download the CDASH User Guide here:

CDASH UG V1-1.1

 

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:

ODM.xml | Data Definitions and CRF Examples (pdf)

 

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:

CDASH CRF Examples

 

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