The Study Status tab allows for the tracking of study activities in the different categories. Some of these categories are:
▪ Study Activity
▪ Reports
▪ Budget
▪ Contract
▪ IRB
Note: It is best practice to maintain the study status as it affects the availability of certain system functions. For example, patients cannot be added to a study unless the status is set to Active/Enrolling.
To change the status of an existing study:
1. From the Study Status tab of a selected study, select Add New Status.
The Study Status Details page displays. Here, users may edit the Study Status information as needed. See the table below for more information about each study status field.
Field Name
Description
Organization
Designates the associated organization.
Status Type
The type of status being cataloged for the study.
Study Status
The study status being documented. The specific values vary based on Status Type. Some of the Study Statuses will impact certain report types as follows:
▪ Active/Closed to Enrollment: This status is linked to reports and will prevent patients being associated to the study if the Flag to All Patient Accrual field is set.
▪ IRB Approved: This status is linked to reports and the IRB Approval Indicator Status flag.
▪ Not Active: This study status is the default status for new studies and is linked to reports.
▪ Study Completed/Retired: This study status is linked to reports and prevents patients being associated to the study.
Documented By
Used to select the user who documented the study information.
Assigned To
Used to select the user that is responsible for monitoring this study status.
Status Valid From
Required date for which the Study Status is valid from.
Status Valid Until
End Date for Study Status.
Notes
Notes on the Study Status.
This is study’s Current Status
Checked by default. This will set the study status for the applicable status type to this study status.
Organization specific current reportable status
Used to report the current status for the designated organization.
2. Using the dropdown menus and text fields, define the study status as appropriate.
3. Enter your e-Signature and click the Submit button.
