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Establishing Data Reviewers

In order for defined users to leverage the review capabilities in the Study > Data module, they must be added on a per-study basis within the Study > Configure > Data Reviewers module. One-to-many ClinSpark users may be defined as data reviewers on a per-study basis.

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Users defined as data reviewers have access to the review functionality in the Study > Data component. Study Monitors (or ‘CRAs’) are the most commonly-established data reviewers for studies.

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Upon defining data reviewers for a study, the following fields are required:

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• User: Defines the user (full name and username) to be established as a data reviewer.

• Reviews Require Signoff: If checked, the reviewer must enter their username and password each time that they mark data as reviewed. If unchecked, username and password are not required.

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Editing Data Reviewers

Users can perform the following actions to manage per-study data reviewer configuration. Note that all of the following actions can be performed at any time during a study without affecting already-documented reviews:

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