Permissions: Users with the RACT Assessment Read Write or RACT Configure privilege can create and configure a study assessment.
Users with the RACT Assessment Read Only privilege can view RACT data to participate in study risk assessment activities.
A Study Assessment can be created for RACT enabled studies. Typically, this is done once the draft protocol is available. Within the study assessment configuration, the assessment frequency, categories, and questions are defined.
Important: A study must have an approved assessment to conduct an assessment.
Access Study Assessment Configuration
Configuration is available from a study's landing page. View a list of existing Assessment Configuration Versions. Columns can be sorted, filtered, and fixed. The number in the blue badge indicates the number of rows in the filtered list. Use the icons at the top right to add, edit, approve, or create a new version of a study assessment, and identify if any filters are applied. Unused or in-development study assessments can be deleted.
Create and Configure a Study Assessment
As new assessments are added and new versions created, they are listed in Configuration, Assessment Configuration Versions.
- Select a study from the RACT Landing Page with a status of Not Started.
- If not automatically directed to the Configuration page, click Configuration in the left navigation.
- Click + Add Configuration. The Configuration window will open, displaying details at the top.
Note: After creating an assessment version, the +Add Configuration button is no longer available. Existing versions can be edited, and new versions can be created.
- Optionally, copy the configuration of an approved Assessment. Select a study from the Copy From Another Study drop-down menu. Only studies with Approved status are listed.
- Update the Assessment Interval (Weeks) by typing over the displayed number or dragging the slider (1 - 99 weeks). The default is 8.
- Optionally, enter Comments.
- Click Create. A confirmation message will appear.
The Configuration window will expand to include Categories and Questions.
Tip: If the configuration was copied from another study, the categories and questions will be pre-selected and can be modified.
Tip: To see all items, use the scrollbars.
Questions - By default all Categories and Questions not excluded by study properties are selected.
Note: Users with the RACT Configure privilege will see the Configure Questions icon. Clicking this icon opens the Questions Library within Configuration.
- Select the desired Categories and Questions by checking the boxes to the left.
- If a configuration was copied from another study, those categories and questions will already be selected. Uncheck any categories or questions to exclude them from the assessment.
- If no configuration was copied, check or uncheck the categories and questions to include in the assessment.
- Confirm your selections and click Save. A confirmation message will appear. The assessment status will change from Not Started to In Development.
Edit a Study Assessment
After an Assessment is created and configured for a study, its status updates to In Development, and it appears in the Assessment Configuration Versions list. The Edit icon opens the Configuration window for making changes.
Note: Once an Assessment is created, the option to copy a configuration from another study is unavailable.
Note: Changes cannot be made to an approved assessment version. A new version must be created.
- Click Configuration in the left navigation, select the latest Assessment Configuration Version.
- Click the Edit icon. The Configuration window will open.
- If the current version's status is Approved, click the Create New Version button at the top right of the window.
- If a new version was created, the window updates to the next version number, retaining all selections from the previous version.
- Make changes by checking or unchecking categories and / or questions.
- Click Save. A confirmation message will appear.
Approve a Study Assessment Version
When an Assessment is created for a study, or a new version is created, its status is In Development. After configuring the assessment, it can be approved.
- Click Configuration in the left navigation.
- Select the Assessment Configuration Version with a status of In Development.
- Click the Approve icon, or right-click the row and select Approve.
Note: The approved version will be used for the next Assessment.
Important: An approved version's status cannot be updated. To make changes, create a new version.
Delete a Study Assessment Version
Only Assessments that were created (version 1) and never used or in development can be deleted.
- Click Configuration in the left navigation.
- Select the Assessment Configuration Version to delete.
- Click the Delete icon. A confirmation message will appear.