Standards in this section guide development and use of case report forms (CRFs) by implementing the CDISC CDASH Model. For a description of the CDASH Model Metadata please see Appendix.
From best practces section - This helps to ensure a quality deliverable, even if the programmer is unfamiliar with data capture practices.
The CDASH Model establishes a standard way to collect data across studies. The
The CDASH Model, the CDASH Implementation Guide (CDASHIG), and the CDASHIG metadata tables define basic standards for the collection of clinical trial data and how to implement the standard for specific case report forms (CRFs). Although the CDASH standard was originally developed for use in regulatory submissions, it can be used by any organization or individual involved in the collection, preparation, and analysis of clinical research data that may also be used for other purposes, including publication, warehousing, and meta-analyses. 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. The CDASH standard directly supports the production of clinical data collection instruments. Through this support, the standard also 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
There is growing global recognition that industry standards promote data interchange, which is essential to effective partnering and information exchange between and among clinicians and researchers. Clinical care can more easily reap benefits through medical research findings, and more clinicians will be interested in conducting research if the research process can be integrated into their clinical care workflow. CDISC encourages the adoption of its global standards for clinical research, which should continue to be harmonized with healthcare standards, to provide a means for interoperability among healthcare and research systems such that medical research can support informed healthcare decisions and improve patient safety.
This document is intended to be used by persons involved in the planning, collection, management, and analysis of clinical trials and clinical data, including clinical investigators; medical monitors; clinical research associates (monitors); clinical research study coordinators; clinical data standards subject matter experts (SMEs); clinical data managers; clinical data and statistical programmers; biostatisticians; drug safety monitors; CRF designers; and others tasked with the responsibility to collect, clean, and ensure the integrity of clinical trial data. Although much of the language in this standard addresses development of (e)CRFs, the CDASH standard can also be leveraged for other data sources. The principles and the metadata presented can be applied to eSource (also known as "non-CRF") data such as vendors' electronic data transfer standards, ePRO data structures, and direct data acquisition from electronic healthcare record (EHR) systems.
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