If data are in scope for a collection domain defined in this guide, but not all data can be represented using the domain data collection fields, then custom data collection fields may be used. The naming conventions and other variable creation recommendations in this guide are designed to allow collection of data regardless of subsequent inclusion in tabulation datasets, as well as to consistently facilitate transforming the collected data into tabulation datasets.
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.
New data collection fields (not already defined in the CDASH Model) will fall under 1 of following categories.