Bypass Review

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.

Similarly forms can be omitted from the workflow across the entire study. This is done by the Study Builder. 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:

The permission to bypass must be granted to a role which is responsible for the workflow review level.

Users who can bypass should also be granted 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 the TrialKit mobile app.

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

  1. The Monitor Report

  2. The Dashboard Report on the TrialKit app

  3. Data Exports

 

Bypassed Record Status

When a record is bypassed, it takes on a unique status value. 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.  If the next review level of, say 11, is then conducted, the status would change from 20 to 11. Exporting an archived history of records should show the progression that occurred on a record, but the non-archived exports will only provide what the current/latest status is.

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