Clinical Data Acquisition Standards Harmonization (CDASH)
CDASH establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.
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. Additionally, CDASH v1.1 includes implementation guidelines, best practice recommendations, regulatory references.
CDASH Serious Adverse Event (SAE) Supplement v1.0
This supplement expands the AE domain in CDASH to include additional data elements to capture information in an SAE form, facilitating Sponsor generation of an E2B message for electronic reporting of an Individual Case Safety Report (ICSR) to regulatory authorities.
CDASH User Guide (UG) v1.0
CDASH UG v1.0 provides implementation examples, including CDASH to SDTM mappings and other helpful implementation information, and should be used as a supplement to the CDASH V1.1 standard.
The CDISC Operational Data Model (ODM) is a vendor neutral, platform-independent XML format for exchanging and archiving research data. CDASH-ODM XML files are an implementation of ODM, providing examples of basic case report form CDASH content in ODM-XML format. The XML may require modification to apply to a particular study or to implement in a particular database system or application.
CDASH Data Definitions and CRF Examples
These PDF files provide a starting point for creating CDASH CRFs and include the data definitions and CRF examples from the ODM-XML CDASH files.
Library of CDASH CRF Examples
A library of example CDASH CRFs has been created in different data collection systems, including paper examples.