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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 collection of data irrespective of the subsequent inclusion of the data in tabulation datasets.

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, determine whether the data will be used for data cleaning the nature of the to be collected aligns with tabulation dataset variable defined in this guide or in the SDTM. a new collection field for a CRF will be categorized as one of the following with implementation as described in the table below.

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