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If data to be collected are in scope for a domain defined in this guide , but not all data can be collected using the domain's collection fields, then collection fields may be added to the applicant's CRF from the CDASH Model, the SDTM, or created by the applicant using guidance belowin the TIG.
Prior to adding fields from the CDASH Model, the SDTM, or considering a new applicant-defined collection field, confirm that none of the fields in the existing domain fields will fit the need. Fields may be added from the CDASH Model, the SDTM, or created only when data are different in nature and are not in scope for existing domain collection fields in this guide.
Adding Fields from the CDASH Model
Once confirmed, the The overall process for extending a domain metadata is as follows:
Creating New Fields
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Using the root variables and other CDASH metadata in the CDASH Model, add any additional variables that are needed to meet the requirements of data collection.
- Refer to both the CDASH Model and Appendix C, CDASH Model Metadata Tables.
Follow CDASH root variable-naming conventions where they exist (e.g., --DAT for dates, --TIM for times, --YN for prompts, as described in the CDASH Model) and align with CDISC NSV Registry conventions as applicable.
- Select variables from the SDTM when fields from the CDASH Model cannot be used. Selection of variables must align with SDTM usage restrictions.
Create a new applicant-defined collection field when fields in the CDASH Model and variables from the SDTM cannot be used.
When creating a new applicant-defined collection field, determine whether the data will be used for an operational use case (e.g.,
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data cleaning
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) or are
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to be represented in a tabulation dataset. In general,
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new data collection fields (not already defined in the CDASH Model) will fall in 1 of following categories:
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a field used for operational,
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data cleaningpurposes only
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;
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a field used to collect data that have
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direct mappingto a target variable in the tabulation dataset
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; or
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a field used to collect data that have
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no direct mapping to a target variable in the tabulation dataset.
Prior to adding a custom field to a CRF, confirm that none of the collection fields in this guide or in the CDASH Model fit the need.
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The following table provides implementation guidance aligned with both the category of the field and target variable.
Metadataspec | ||||||||||||||||||
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If data are not in scope for a domain in this guide, a custom domain can be used. An existing domain may help in selecting the fields and terminology needed for the custom domain. The custom domain must be based on one of the SDTM general observation classes. See Section 2.8.3 How to Create New Specifications for further information.
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