Call for Public Review: CDASH Draft Data Collection Variables

The CDASH consolidated draft document is now posted for public review and comment. 

Comments are due to Rhonda Facile by 14 May 2008.

This document contains draft data collection variables for 16 safety data domains, i.e. the most common clinical safety questions can be answered using these collection variables.  Through standardizing the basic data collection variables efficiencies can be gained both by streamlining procedures at clinical investigative sites and contributing to data quality and integrity. The intention is that these basic variables will be supplemented by therapeutic area collection variables to create a Case Report Form (CRF).

This work is funded through a Collaborative Group of 17 organizations and is supported by the work of over 190 volunteers representing 106 companies that includes representatives from Industry, Contract Research Organizations, eVenders, and Government Stakeholders over the past year and half.

CDASH is interested in receiving review comments from any and all interested parties by 18 May 2008.  Please use the comment spreadsheet and submit all comments to rfacile@cdisc.org.  

Download Review package

Access Review package Instructions

Access Review package comment spreadsheet