AUSTIN, Texas--(BUSINESS WIRE)--The Clinical Data Interchange Standards Consortium (CDISC) has agreed to lead a project to address one of the Food and Drug Administration’s (FDA) Critical Path Initiative Opportunities: Consensus on Standards for Case Report Forms (CRFs). “A wide array of different forms and formats are used to collect clinical trial information, and most data are submitted to the FDA on paper. Differences in case report forms across sponsors and trials create opportunities for confusion and error,” states this document: http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf. The CDISC Clinical Data Acquisition Standards Harmonization (CDASH) project is designed to address this problem.
