Record/CRF Reviewing Overview

Owned by TK Support, created
Dec 21, 2020
2 min read

Instructions

Record review levels are set up by the Study Administrator based on user roles. If you have the ability to review and/or sign off on records, a button will be displayed at the bottom of every subject CRF to mark the corresponding data as reviewed at your role level (e.g. Monitor reviewed, Investigator Reviewed, etc). Bulk review functionality is also available from the Action Item Report if the study is set up to support it.

Important points on how record review works in TrialKit:

  1. Data review workflow in TrialKit can be configured to allow only completed records (no open queries) to be reviewed/locked. Alternatively, studies can be set up to allow the first review level (typically Monitors) to perform initial verification regardless of the form's current state. Data changes on Monitor tagged forms will break the soft review level only if there are open queries on the form. This gets logged in the audit trail and Monitor Report so it is transparent to all users. 

    1. Reviewing should not be confused with Freezing, which can be done anytime by anyone with that permission. Not all users will necessarily see the option to freeze forms.

    2. Studies may also be set up for partial review capabilities where a reviewer can lock individual fields on forms to prevent further data changes on specific data points. In these cases, an entire form cannot be reviewed until all necessary fields have been locked on the form. Site users may also have the permission to unlock (or un-monitor) those fields if they need to make a change. Monitored or unmonitored (locked or unlocked) fields are clearly shown in the Field Lock (FLSV) Report.

  2. For a CRF to be reviewed or locked by the first review level (typically a study Monitor), depending on the study design, may first require that all queries are closed on the form.

  3. For a list of records awaiting a review level, use the Action Item Report. The progression of records through review levels can be referenced on the Dashboard Report. For Monitors to track any initial verifications and subsequent changes that sites have made, use the Monitor Report.

Continue reading about how to open and review records.

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