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The standardized formats of clinical research data have been developed and established by the Clinical Data Interchange Standards Consortium (CDISC), which is addressing standardization in order to support the acquisition, exchange, submission, and archive of clinical data from individual trials and their metadata [1]. CDISC has developed the Clinical Data Acquisition Standards Harmonization (CDASH), which is a standard for data collection [2-4]. Data reliability, integrity, and exchangeability for clinical research depend greatly on having accurate and uniform definitions of the data items to be collected and the design of case report forms (CRF). The use of CDASH is very helpful for standardizing the items and data formats in a CRF for any trial across different research institutions.

Case Report Form (CRF) Design Made Easy: An Evaluation of Clinical Data Acquisition Standards Harmonization (CDASH) in Use