REASON — define the text that will be inserted into reason for data change records for each data value that is changed and applied to the database
During processing of an edit check, a data value may be changed. Further, that data value may have been defined in the study setup so that it has a minimum reason level after which all data value changes require reasons. If the changed data value is applied to the database, and the record's validation level is at or above the minimum reason level, then a reason is required. The text of this element is used as the reason.
If, in the batch definition, this element is not present or is invalid
(i.e. contains '|' or control characters, or consists entirely of an empty string)
and a reason is required for a data value change that is to be applied to the database,
then the system creates a reason text that is the concatenation of the
fixed string DFbatch and the current batch's name.
This element applies to all of the BATCH elements in the
current BATCHLIST.