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Gary: I think this language is awkward, but I am unclear as to how it should be updated.

If data cannot be collected using fields in this guide, then a custom collection field may be used. 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 data cleaning, an operational use case, or are actual data that will be represented in a tabulation dataset. In general, a new field for a CRF will fall into one of the following categories:

  • Data Cleaning, indicating a field that will support data cleaning only.
  • Direct Mapping, indicating a field that will map directly to a tabulation dataset variable.
  • No Direct Mapping, indicating a field that does not have a direct, one-to-one mapping to a tabulation dataset variable.

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 may be followed.

NumField CategoryTabulation TargetImplementation
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 sponsor business rules using CDASH naming fragments (e.g., --DAT, --TIM) as appropriate and CDISC variable naming fragments where possible. (See the SDTMIG appendices.)



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