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If data cannot be collected using a field fields in this guide, then a custom collection field may be used. Naming conventions and other variable creation recommendations Guidance for field creation in this section are designed to allow collection of data irrespective of subsequent inclusion in tabulation datasets.

Prior to adding a custom field to a CRF, confirm that none of the data collection fields in this guide or in the CDASH fit the need. Once confirmed, a new data collection field for a CRF will fell in be categorized as one of the following:

• Field for 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.

New data collection fields (not already defined in the CDASH Model) will fall under 1 of following categories.

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