CDASH v1.1 Developed with participation from organizations in all three ICH (International Conference on Harmonization) regions (US, Europe and Japan), CDASH v1.1 describes the recommended data collection fields for 16 domains, including demographics, adverse events, and other domains common to most therapeutic areas and clinical research phases.

The CDASH Model provides naming conventions for the CDASH Implementation Guide (CDASHIG) variables along with additional metadata to help facilitate mapping collected data to their respective SDTM Implementation Guide (SDTMIG) variables.

The CDASH Model organizes data into classes, which represent meaningful groupings of data in clinical research. It defines CDASH metadata for identifier variables, timing variables, general observation class variables (Events, Interventions, and Findings), domain-specific variables, and special-purpose domain variables, (e.g., DM, CO).

CDASH and SDTMI are designed for different, if overlapping, purposes, and each has variables that support its particular function. SDTM’s primary focus is pooling data for submission or warehousing, whereas CDASH’s primary focus is collecting data for individual subjects in individual studies.

2021年9月28日 · CDASH Model v1.2 provides root-naming conventions for CDASHIG variables, intended to facilitate mapping to SDTMIG variables. The model also provides root-naming conventions for TIG collection variables with intended mapping to tabulation datasets.

2023年9月28日 · The CDASH Model organizes data into classes, which represent meaningful groupings of data in clinical research. It defines CDASH metadata for identifier variables, timing variables, general observation class variables (Events, Interventions, and Findings), domain-specific variables, and special-purpose domain variables, (e.g., Demographics ...

2019年11月1日 · Version 2.1 of the CDASH Implementation Guide provides information on the implementation of CDASH Model v1.1 and includes the CDASHIG Metadata Table, which details additional specifications for data collection variables within each domain.

2017年9月20日 · The CDASH Model v1.0 describes the foundational structure for the organization, naming, and description of variable and associated attributes to support data collection in clinical trials.

The eCRF Portal consists of ready-to-use, CDASH-compliant, annotated eCRFs, available in PDF, HTML and XML, to use as is or import to an EDC system for customization. The eCRFs are examples and are not meant to imply that any particular layout or …

Describe the CDASH model and implementation guide and their purpose in data collection; Explain the relationship of CDASH to SDTM, Controlled Terminology and other CDISC standards; Describe the value of CDASH standards in the clinical research process; Select appropriate variables for a CRF based on core designations