With a single permission, users who are part of the study review workflow can bypass review on any record. This is useful for scenarios utilizing risk-based monitoring or where specific forms do not need to be verified. In contrast to this, Clinical Studio has a feature where specific forms can be omitted from the workflow across the entire study. However, in many situations, the forms that need to be omitted may change from subject to subject, or site to site. This is where bypassing review comes in. It allows the user responsible for review to choose what they need to review and bypass what does not need to be reviewed.


Setup:

For Study Managers, the permission to bypass is granted to user roles from role security settings under the subject record management list.

Users who can bypass should also be granted the permission to "Batch Review" records. This is so multiple records can be selected and bypassed at once.


Bypassing Review:

If a user, such as a study Monitor is a reviewer of records, bypassing review can currently only be done from the Action Item Report. This can be done on both the web and TrialKit mobile app.


Records that are bypassed can be tracked in a couple different ways:

1) The Monitor Report

2) The Dashboard Report on the TrialKit app

3) Data Extracts



When a record is bypassed, it takes on a unique status. All records have a status value. Bypassed records take on a status of 10 plus whatever the status for the workflow level is set at. As an example, if the study workflow is set up to stamp a status of 10 to the Monitor level review, and the Monitor bypasses review, the record will take on a status of 20.