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- Part of the Clinical Data Interchange Standards Consortium (CDISC) Foundational Standards.
- Establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data in the Study Data Tabulation (SDTM), delivering more transparency to regulators and others who conduct data review.
- CDISC develops its own Controlled Terminology
- Latest version is v2.1, published in November 2019.
- The CDASH IG defines basic standards for the collection of clinical trial data and how to implement the standard for specific case report forms (CRFs)
- Supports the production of clinical data collection instruments and contributes to consistency and detail in representations of research protocol concepts, streamlined processes within medical research, development of a corporate library of standardized CRFs, use of metadata repositories, reporting and regulatory submission, data warehouse population, data archiving, post marketing studies/safety surveillance
- 3 Components:
- CDASH Model - provides a general framework for creating fields to collect information on CRFs and includes the model metadata
- CDASHIG - general information on the implementation of CDASH standards
- CDASHIG Metadata Table – includes only variables commonly implemented by a significant number of organizations that provided information (medical history, adverse events, etc.)
- Model includes: Observation Class, Domain, Order Number, CDASH Variable, CDASH Variable Level, DRAFT cDASH Definition, Question Text, Prompt, Data Type, SDTM Target, Mapping Instructions, Controlled Terminology Codelist Name, Implementation Notes
- Uses a Controlled Terminology, developed and operated by NCI Enterprise Vocabulary Services.
CDASH and HL7
- Work is being done to harmonize CDASH standards into HL& standards using BRIDG
- There is will be a mapping of FHIR resources to CDISC standards and an IG in 2021
- This will leverage existing work from the EHR-to-CDASH project, which developed mappings to enable the transfer of healthcare data into a form for collection into clinical research
CDASH and mCODE
- CDASH is very focused on clinical trial information and standardizing CRFs, mCODE is not focused on clinical trials.
- CDASH includes variables such as informed consent.
- Medication information is more detailed in CDASH than mCODE (treatment vehicle, strength, fasting, etc.)
- CDASH includes adverse events and toxicity, mCODE does not.
- CDISC uses its own Controlled Terminology, mCODE uses existing terminologies such as SNOMED.