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After selecting a patient, visit, form, or item, use the icons in the lower right corner to work with queries, track reviews, or change the status. You can also access these icons from the navigation pane on forms.
Note: These actions may be applied to any object with any status except Locked.
Applying an icon to a higher-level component changes the status of the components below it, including repeating sections. For example, if you freeze a visit, all the forms within the visit are also frozen.
Note: eSignatures are not propagated to other levels of the hierarchy; that is, the signatures at different levels are completely independent of each other. The audit trail reflects this independence. Additionally, if you make a change to a repeating section of a signed form, the status of the form changes to Unsigned.
Manually applied query, review, and status icons
Action | Icon | Description |
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Query-related |
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Create a query |
| Issue a manual or candidate query about the patient, visit, form, or item. |
Respond to a query |
| Display the selected queries on the Query List page and answer the queries on the Answer tab. |
Modify a query |
| Open the selected query in the Detail section of the Query List and change the status. If you apply the status at the form level and there are multiple queries associated with the form, the Query List page appears. |
Approve a query |
| Review an answered query and change the status to Approved. |
Reissue a query |
| Reject the answer to a query and reopen the query. |
Close a query |
| Mark a query as closed. |
Delete a Candidate query |
| Visible only to sponsor users, use this icon to delete a candidate query. |
Review-related |
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Unmark DM Reviewed, Mark DM Reviewed |
| Unmark or mark a visit, form, or item DM Reviewed. DM Reviewed indicates that the data entries have been reviewed by a clinical data manager. Changing the data automatically activates the Unmark status. |
Unmark SDV , Mark SDV |
| Unmark or mark a visit, form, or item SDV (Source Document Verification) Reviewed. SDV review indicates that the data has been reviewed against the source data. Changing the data automatically activates the Unmark status. |
Remove Remote Review, Mark for Remote Review |
| Mark a visit, form, or item reviewed remotely, or remove the remove review mark. In a remote review, the data manager or monitor checks the data for completeness away from the site. Data is not checked against source documents. Changing the data automatically activates the Unmark status. |
Unsign, Sign |
| Unsign or sign the selected patient, visit, form, or item. The OutcomeLogix application automatically requests authentication of the user. Changing the data automatically activates the Unsign status. |
Status-related |
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Unfreeze, Freeze |
| Unfreeze or freeze the patient, visit, form, or item. Frozen data has been reviewed and cannot be modified at this time; however, queries can be opened, answered, or closed while the data is frozen. Depending on the result of the data change from a query, the automatic system form statuses update accordingly. In addition, manual form statuses can be applied while in a frozen status. You can modify the data only through the Queries List page or the Query Detail dialog box. |
Unlock, Lock |
| Unlock or lock the patient, visit, or form. No further modification to the data is permitted. |
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