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Prior to adding any new fields to a sponsor's study CRF, the CDASH Model should be reviewed to see if there is a 
root field that will work for the data collection need

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 to be represented in a tabulation dataset. In general, a new field will fall into one of the following categories:

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