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The CDASH Model establishes a standard way to collect data across studies. Guidance in this section implements the CDASH Model for the TIG Product Impact on Individual Health use case and provides:

• Basic standards basic data collection guidance and best practices for data collection.
• Guidance for development, management, and use of case report forms (CRFs).
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• 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 The TIG standard directly addresses development of CRFs but does not formally address data collected collection 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 and ePRO data structures, as applicable.

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

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• Refers to both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified.

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• Refers to where data is collected in a CRF.

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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.