Summary
Edit Checks provide a means of flagging data as nonconformant when established conditions are contradicted, ensuring that ‘undesirable’ data is easily identified during study monitoring or data cleaning. Edit Checks are established within the CRF Design > Study Library component, associated with the Item against which a nonconformant flag should be returned if conditions are contradicted. Example use cases for edit checks may include:
Flagging responses that make a subject ineligible
Ensuring that a subject assumed a given position X minutes prior to vital signs collection
Forcing adverse events to remain in a nonconformant state until the AE is no longer ongoing
Understanding Edit Checks
Name: For organizational purposes only, edit check name helps users locate edit checks in the study library.
Description: For organizational purposes only, edit check description helps users understand the intended purpose of the edit check.
Soft: If checked, the nonconformant flag may be removed during data collection by entering an annotation against the corresponding item. If unchecked, the nonconformant flag will persist until ‘undesirable’ conditions defined by the edit check are no longer met.
Error Message: This error message is displayed to users along with the nonconformant flag upon saving undesireable data as defined by the edit check.
Comparator: In conjunction with the ‘Check Values’ field, the comparator field is used to specify desirable item values.
Check Values: In conjunction with the ‘Comparator’ field, the check value field is used to specify desirable item values. If the value being checked is contained in a code list, specify the coded value.
Formal Expression Context: For organizational purposes only, formal expression context is used to describe who wrote the edit check. Typically, this will be FH if Foundry Health wrote the edit check or Customer Name if the customer wrote the edit check.
Formal Expression: The machine-readable Formal Expression field is leveraged for edit checks in which conditions are dependent upon more than the associated item value.
Attaching Edit Checks to Items
An edit check is attached to the Item for which a nonconformant flag is to be returned if undesireable conditions are met.
Assumptions and Conditions
Edit checks fire upon saving the containing Form.
When leveraging the ‘Comparator’ and ‘Check Values’ fields, specify desirable item values.