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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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Guidance in this section implements the CDASH Model

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• 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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for the TIG Product Impact on Individual Health use case and provides:

• basic data collection guidance and best practices;
• guidance for developing, managing, and using CRFs, irrespective of the inclusion of collected data in subsequent tabulation datasets; and
• guidance for mapping data collected via CRFs to tabulation datasets be used to as applicable with guidance in Section 2.8, Standards for Tabulation.

The TIG supports development of CRFs but does not formally address data collection via other sources. Guidance in this section suggests a format to be presented to those entering collected data using CRFs but does not dictate any data structure or system in which to store the collected data. Applicants may choose to develop libraries of CRFs for organizational use. In such cases, following both the CDASH Model and TIG recommendations, taking into consideration both scientific and regulatory requirements, is recommended. To gain the greatest benefit, CRFs should not be developed on a study-by-study basis within the implementer organization, but rather be brought into a study from a library of approved CRFs based on the CDASH Model and the TIG, whenever feasible.