Abstract

CDISC-CDASH STANDARDS FOR COLLECTION OF CLINICAL TRIAL DATA

Praveen Kumar Jinka*

ABSTRACT

The article is mainly describes the scope of CDISC-CDASH standards for eCRF data collection in Clinical Trail. CDASH-DEFINATION: Clinical Data Acquisition Standards Harmonization (CDASH) Standard defines recommended basic standards for the collection of clinical trial data. The CDASH standard is part of the Clinical Data Interchange Standards Consortium (CDISC) Technical Road Map, which is designed to realize the vision of a set of end-to-end harmonized standards for the collection of data from clinical studies. It develops content standards for a basic set of global industry-wide CRF fields to support clinical research (element name, definition, metadata).

Keywords: CDISC-CDASH standards, global industry-wide CRF.