Standards in this guide are end-to-end implementations of CDISC models that which are designed to ensure the traceability and transparency of data across activities in the data lifecycle. Implementation of standards in this guide models per this guide with relationships across activities is further described in the table below.
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| Relationship | Standards for Collection | Standards for Tabulation | Standards for Analysis |
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| CDISC model | The CDASH Model | The SDTM | The ADAM | | TIG use case | Product Impact on Individual Health only |
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| Metadataspec |
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| Standards for Collection | Standards for Tabulation: The SDTM | Standards for Analysis: The ADaM |
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CDASH Model - In this guide, the CDASH Model is implemented to support development of CRFs for the Product Impact on Individual Health use case. The CDASH Model is the earliest model implemented for this use case.
- The CDASH Model defines a basic set of data collection fields that are expected to be present on the majority of CRFs.
- Data collected via other sources are not formally addressed in this guide. However, the principles and metadata in this guide may be applied to eSource (also known as "non-CRF") data, such as vendors' electronic data transfer standards and ePRO data structures.
- The use of CDASH data collection fields and variables is intended to facilitate mapping to datasets implemented SDTM structure. When submitted data can be collected as represented in an SDTM dataset, with no transformations or derivations, the SDTMIG variable names are presented in the CDASHIG metadata table and should be used to collect the data. In cases where the collected data must be transformed or reformatted prior to inclusion in an SDTM dataset, or where a corresponding SDTMIG variable does not exist, CDASH has created standardized data collection variable names.
| SDTM - The SDTM is implemented for use cases
| ADaM | | Standards for Data Exchange |
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