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As you enter visits and complete forms, the OutcomeLogix application tracks your progress and displays corresponding status icons on the Patient Summary page at the patient, visit, form, and item levels, including repeating sections within forms. For forms with repeating sections, a summary grid contains a Form Status column showing the status of each instance of the repeating section.
At any time, you can see this list of forms and query statuses by clicking the down arrow in the upper right corner of the page and clicking Status Legend.
Automatically applied statuses
Status | Icon | Description | |
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Form Status |
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Not started (Blank) |
| Data entry has not begun. | |
In-Progress |
| Data entry is incomplete. | |
Incomplete with open queries |
| Awaiting a response from a site user; typically an investigator or clinical research coordinator. | |
Source Verified |
| A reviewer has checked the data against the source data. | |
DM Reviewed |
| A clinical data manager has reviewed the data entries. | |
Remotely Removed |
| A data manager or monitor has checked the data for completeness away from the site. Data was not checked against source documents. | |
Intentionally Left Blank |
| A site user has left the form blank and will complete it later. | |
Complete |
| Upon submission, a form moves to the Complete status if all required fields are complete and no outstanding open queries remain on the form. | |
Signed |
| A site user, typically an investigator, has signed off on the patient, visit, form, or item. | |
Frozen |
| The patient, visit, form, or item has been frozen and cannot be modified. Queries can be opened, answered, or closed. | |
Locked |
| The patient, visit, form, or item has been locked and cannot be modified. | |
Signed at parent level |
| An object at a higher level in the object hierarchy has been signed (for example, the visit in which a form appears has been signed). The design of your study determines whether a visit, form, or item that is signed at a higher level in the object hierarchy can be considered signed itself. | |
Query Status |
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Open Query |
| Awaiting a response from a site user; typically an investigator or clinical research coordinator. | |
Approved Query |
| Query response was approved by a sponsor user. A site user entered the expected response to the automatic query (considered closed). | |
Candidate Query |
| A sponsor user issued a manual query visible only to sponsor users. May be reissued as an Open query. | |
Deleted Query |
| A sponsor user deleted a manual query. | |
Answered Query |
| Received a response from a site user. Awaiting review by a sponsor user. | |
Closed Query |
| The query has been manually closed. | |
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