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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 fields may be added from the CDASH Model or created using guidance below. Prior to adding fields from the CDASH Model or considering a new field, confirm that none of the existing domain fields will fit the need. Fields may be added from the CDASH Model or created only when data are different in nature and are not in scope for existing domain fields.  

Adding Fields from the CDASH Model

The overall process for extending a domain is as follows:


Creating New Fields

Guidance for field creation in this section supports data collection irrespective of its inclusion in subsequent tabulation datasets. When considering a new data collection field, determine whether the data will be used for an operational use case, such as data cleaning, or are actual data to be represented in a tabulation dataset. In general, a new field will fall into one of the following categories:

  • A field used for operational, Data Cleaning purposes only.
  • A field used to collect data that have Direct Mapping to a target variable in the tabulation dataset.
  • A field used to collect data that have 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.

Once confirmed, the following guidance will be used to add a new field to a CRF.

NumField CategoryTarget Tabulation VariableImplementation
1Data CleaningNAThe field --YN with Question Text "Were there any [interventions/events/findings]?" can be used for this purpose. Replace the two dashes (--) with the two-character domain code and create the Question Text or Prompt using generic Question Text or Prompt from the CDASH Model as a base. Always create custom data-cleaning/operational variables using consistent naming conventions.
2Direct MappingYesIf a value can be collected exactly as it will be reported in the tabulation dataset (i.e., same value, same data type, same meaning, same controlled terminology), the tabulation variable name will be used as the data collection variable name in the operational database to streamline the mapping process. Extensions may be appended if needed to create a unique variable name in the collection database. Any collection variable whose meaning is the same as tabulation variable will align with tabulation variable and the meaning will not be modified for data collection.
3

No Direct Mapping


Yes

If a value cannot be collected in alignment with the tabulation dataset variable (e.g., collected data type is different from the data type in the corresponding tabulation variable) or if the tabulation variable is derived from the collected value, then the operational database should use a collection variable with a different name from tabulation variable into which it will be mapped.

No

If a field does not align with a tabulation variable, a unique name should be assigned based on applicant business rules using CDASH naming fragments (e.g., --DAT, --TIM) as appropriate and CDISC variable naming fragments, found in Section x.x, CDISC Variable-naming Fragments, where possible. 

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