Out of Range Data

Summary

‘Out of Range’ data will be item group data that contains an item with something marked out of range. ‘Out of Range’ data is an additional qualifier describing collected data and is mutually exclusive from the from states of unsaved, incomplete, nonconformant and complete. For example, something can be Complete and also ‘Out of Range’ where there is a ‘soft’ range violation and a comment is provided. ‘Out of Range’ boundaries can be established by performing an Edit Item and either executing Edit Item Soft Lower and Edit Item Soft Upper; Edit Item Hard Lower and Edit Item Hard Upper or by setting the soft and hard boundaries through the Add Item Edit Check functionality.

Soft and hard limits cannot match, meaning, the hard range should always be outside of the soft range.

The purpose behind these range differences is based on how ClinSpark handles nonconformant data. Values that fall outside of soft ranges will mark the item as nonconformant, with the ability to remove the nonconformance with an annotation. Whereas falling outside of hard range does not allow the nonconformance to be removed with an annotation. Typically, hard ranges represent physiologic limits (and if data falls outside of that range it was likely entered wrong).

For something like age checks, we typically recommend a hard range of something like 0-99. It would be clear in those scenarios that a mistake was made. Soft ranges typically reflect what’s in the protocol.