Quality Review

This section helps you understand the Quality Review/Audit application in Trial Interactive that allows creating Quality Review profile, recording auditor’s review and comments on various documents added for audit in a trial.

The Quality Review module of Trial Interactive tends to be used in a variety of ways depending upon individual study needs and internal SOP requirements. However, the most common usage of this is as a post-QC review of document and information quality and accuracy. These audits can be conducted internally or an audit can be set up specifically for an external auditor or inspector to come in and review your study room.

In cases where an external auditor will be conducting the review, you may want to grant them specific access as a Regulatory Agency Inspector so that they can be adequately trained in a limited amount of time. For additional information regarding user management, please see the related section of the user guide.

The Quality Review module can be found in the Navigation Grid. Room administrators will always be able to see the Quality Review tile but other user access levels will need to first be indicated as an active participant in an audit as an Auditor or an Audit Manager before the tile will appear. Audit Responders conduct their document corrections from the Documents module and will not see the Quality Review tile unless they also have one of the other roles.