Standards in this guide are end-to-end implementations of CDISC models designed to ensure the traceability and transparency of data across activities in the data lifecycle. Implementation of standards in this guide . The TIG provides instructions and recommendations to implement these models for the collection, representation, and exchange of tobacco product data. Controlled terminology and formats support implementation of all models. Standards for data exchange are applicable to all use cases and allow for the exchange of metadata for CRFs, tabulation datasets, and analysis datasets.
The following table describes implementation of CDISC models with supporting standards and TIG sections.
| Metadataspec |
|---|
| Use Case | Standards for Data | |
| Metadataspec |
|---|
Standards for Collection | Standards for Data Tabulation |
: The SDTM | Standards for Data Analysis |
: The ADaMThe CDASH Model - In this guide, CDASH is the earliest model implemented in the data flow.
- CDASH defines a basic set of data collection fields
- is earlier in the data flow and defines a basic set of data collection fields that are expected to be present on the majority of CRFs.
- SDTM and CDASH are clearly related. The use of CDASH data collection fields and variables is intended to facilitate mapping to the 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.
| The SDTM | The ADaM | Standards for Data Exchange | |
...
| Product description | Not applicable, as data are not collected via CRFs. | Data: Controlled terminology and formats: Data exchange: | Data: Controlled terminology and formats: Data exchange: | Nonclinical | Not applicable, as data are not collected via CRFs. | Data: Controlled terminology and formats: Data exchange: | Not applicable, as data may be analyzed directly from tabulation datasets. | Product impact on individual health | Data: Controlled terminology and formats: Data exchange: | Data: Controlled terminology and formats: Data exchange: | Data: Controlled terminology and formats: Data exchange: | Product impact on population health | Not applicable, as data input parameters generated for population modeling are calculated via upstream analyses. | Not applicable, as data input parameters generated for population modeling are calculated via upstream analyses. | Data: Controlled terminology and formats: Data exchange: |
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