| Table of Contents |
|---|
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.
...
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.
...