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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.

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 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.

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Guidance in this section implements the CDASH Model and provides:

• Basic standards and best practices for data collection.
• Guidance for development, management, and use of case report forms (CRFs).

The TIG standard directly addresses development of CRFs but does not formally address data collected via other sources. However, the principles and metadata presented can be applied to eSource (also known as "non-CRF") data, such as vendors' electronic data transfer standards

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and ePRO data structures,

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as applicable.

Language in the table below is used throughout this section in the context of data collection and should be interpreted as specified.