Monitoring and Review for Data Locking

Summary

For data monitoring and review workflows, sponsors may want to know that all reviews are completed in order to trigger database locking. In some instances, study monitors may not review all forms, but apply a risk-based approach.

ClinSpark can help in this scenario using filtering capabilities in Study > Data.

• Forms; Optionally select the forms that are required to be reviewed per risk-based approach

• Status; Selecting ‘Complete’, ‘Incomplete’, and ‘Nonconformant’ statuses are eligible for review

• Reviews; Select ‘Unreviewed’ and applicable users/CRAs

Open

Given the above filters, the end goal would be for no search results to return. If no result are returned, the study should be in an appropriate state to lock. However, if data is returned by the search, it likely warrants some sort of action.

More information about study monitoring and database locking can be found in these help guides:

• How To Monitor A Study

• Database Locking