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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 an operational use case, such as data cleaning, or are actual data that could be represented in a tabulation dataset. In general, a new field for a CRF will fall into one of the following categories:

• A field used for Data Cleaning , indicating a field will support data cleaning purposes only.
• A field that has a Direct Mapping , indicating a field will map directly to a tabulation dataset variable.
• A field with No Direct Mapping , indicating a field 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 will be followed used to add a new field to a CRF.

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