CDISC CDASH 1.1

Version 1.1 of the Clinical Data Acquisition Standards Harmonization (CDASH) standard identifies the basic data collection fields needed from a clinical, scientific, and regulatory perspective. The data collection fields enable more efficient and consistent data collection at clinical research sites.

This standard is designed to be used by clinical trials personnel who are responsible for collecting, cleaning, and ensuring the integrity of clinical trials data.

The CDISC CDASH and CDISC SDTM standards are related. The CDISC SDTM standard provides a standard for the submission of data. The CDISC CDASH standard is needed earlier in the data flow process. It defines a basic set of data collection fields (or variables) that are expected to exist in the majority of CRFs. The data collection fields are highly recommended, recommended, or conditional. The CDASH data collection fields facilitate mapping to the CDISC SDTM structure, which is required for the submission of data.

The CDASH 1.1 standard describes the basic recommended data collection fields for 16 domains commonly used in clinical trials.

CDISC Clinical Data Acquisition Standards Harmonization (CDASH) Standard, Version 1.1, January 18, 2011

The SAS Clinical Standards Toolkit representation of the CDISC CDASH 1.1 standard consists of 16 domains. Unlike the SAS Clinical Standards Toolkit representations of other standards, multiple records per domain can be in the reference_tables metadata data set, and multiple records per column can be in the reference_columns metadata data set. These multiple records enable specification for the Findings domains of multiple scenarios (such as whether laboratory data undergoes processing at a local or central lab), multiple views (such as whether data is collected in normalized or de-normalized formats), and multiple languages.