Review Status Code

Oracle Clinical ships with these review status codes:

• Unreviewed: Oracle Clinical assigns an initial review status value of Unreviewed to each new discrepancy.

• CRA Review: Assigned to the Clinical Research Associate for review.

• DM Review: Assigned to the Data Manager for review

• INV Review: Assigned to the Investigator for review.

• TMS in Progress: The system assigns this status to discrepancies that are currently owned by Oracle Thesaurus Management System (TMS). This happens when a question response that is set up to be coded to a dictionary term in Oracle Thesaurus Management System (TMS) cannot be automatically classified, and First Review is set to TMS, or after a user in Oracle Clinical has set the status to TMS Evaluation. You cannot take any action on this discrepancy in Oracle Clinical.

• TMS Evaluation: If a TMS user has a question about a response that he or she is trying to code in TMS, he or she can assign an action to the term asking for clarification or some other action. The system then assigns a status such as INV Review (this is configurable; see the Oracle Thesaurus Management System User's Guide for information). After you take the action on the term, set the discrepancy's status to TMS Evaluation so that batch validation transfers ownership of the discrepancy back to TMS and changes its status to TMS in Progress.

• Resolved: Not assigned to any person or process. Setting a discrepancy's status to RESOLVED does not cause the system to close the discrepancy. That happens only when the data is no longer discrepant, either because the data has been updated to a nondiscrepant value or because the validation procedure or question attribute that flagged the value as discrepant has been changed in such a way that the existing value is no longer considered discrepant.

  If you set the discrepancy review status to Resolved, you must also select a resolution status.

• Irresolvable: Not assigned to any person or process because it is not possible to resolve the discrepancy. Setting a discrepancy's status to IRRESOLVABLE does not cause the system to close the discrepancy.

  If you set the discrepancy review status to Irresolvable, you must also select a resolution status.

• Closed: The system sets a discrepancy's status to Closed when it is resolved by either updating the data to a nondiscrepant value or changing the validation procedure or question attribute in such a way that the existing data is no longer discrepant. The discrepancy's system status changes to Obsolete and the discrepancy is removed from its DCF (if any) and no longer appears as current in discrepancy reports.

Your organization can create custom review statuses to reflect your own review process, and specify which personnel (user roles) are allowed to set which review statuses, by defining several Installation Reference Codelists; see the Oracle Clinical Administrator's Guide for more information.