Permissions: RACT Assessment Read Only: Users can view RACT data to participate in study assessment activities.
RACT Assessment Read Write: Users can add and configure study assessments, initiate, continue, and finalize assessments, add and manage critical data, critical processes, and risk statements for a study.
RACT Configure: Users have the same privileges as the RACT Assessment Read Write privilege, plus they can configure Questions Library, Question Exclusions, Categories, Functional Plans, Response Strategies, and Risk Statements.

The Risk Assessment and Categorization Tool (RACT) supports the initial and ongoing assessment and categorization of risks associated with a clinical study. It also documents the action plans that the study team adopts to address those risks.

The RACT features:

• Assessment of initial study risks and periodic revisions through interim assessments.
• Identification and tracking of critical data and processes, linking identified study risks to relevant critical items.
• Review of identified study risks and assessment scores to gain insights through the analysis of past assessments.
• Management of study assessments and updates to study-specific assessment tools.
• Management of assessment questions, categories, functional plans, response strategies, and risk statements to tailor the RACT experience to existing business processes.

The Risk Assessment & Categorization Tool (RACT) can be accessed from the Platform Menu under Risk Management.

A user with the RACT Configure privilege must first configure questions, categories, functional plans, response strategies, risk statements, global critical data, and global critical processes. A user with the RACT Configure or RACT Assessment Read Write privilege can configure study-specific assessments. Once a study assessment is approved, the study team conducts the initial assessment. After the initial assessment, adjustments can be made, and the study team continues with ongoing assessments.

Listing Functionality

Most columns in the lists can be sorted, filtered, resized, and fixed. Click a column header to sort or filter; right-click a column header to fix it to the left or right.

To filter, click a column header, select Filter, enter your criteria, and click Filter Rows. Filtered columns display a solid filter icon in the header; the Filters icon (top right) will also be solid. Use the Filters icon to clear all filters, or remove them individually. 

The blue badge indicates the number of rows in the filtered list.

Click the back arrow at any time to return to the RACT Landing Page.

RACT Landing Page

All RACT-enabled studies are listed on the RACT Landing Page. 

Users can favorite studies by clicking the star icon to the left of a study name. Clicking the Favorite (star) icon in the master header filters the list to show only favorited studies. 

The columns include the study Name (a hyperlink to the study's landing page), Status, Last Assessment Date, and Next Assessment Due Date. The Next Assessment Due Date will be blank if a RACT Assessment is finalized without starting a new one.

Users with the RACT Configure privilege will see the Configuration button in the master header.

Statuses are: 

• Not Started: The initial study assessment has not been created and configured. 
• In Development: The study assessment version has been created but not yet approved.
• Approved: The most recent version of the assessment that can be used to conduct an assessment. Any revisions to an approved version creates a new version.

From the list of studies, users can access a study's landing page by clicking on its name.

Study Landing Page

Across the Top

The master header includes the 9-dot icon (to open the Platform Menu), the elluminate logomark (which returns the user to their default landing page), and the question mark icon (to open the Help menu).

Below the master header is a left-facing arrow that returns the user to the RACT Landing Page.

• Click the back arrow to go Back to all Studies.
• See the study name of the study-specific landing page in view. Click the down arrow next to the study name to select a different study's landing page.

Other top items vary depending on the left navigation selection. For example, the screenshot shows Assessments selected. The user is directed to either Assessments or Configuration, depending on the study assessment status: studies with Approved assessments go to Assessments; studies In Development will go to Assessments if an approved assessment from a previous version exists; otherwise, they go to Configuration if configuration is incomplete; and studies with Not Started status go to Configuration. The orange bar next to Assessments indicates that the assessment is displayed for the current study. The orange underline under the Categories tab indicates that the categories are displayed. Users can click the Participants tab to view the list of assessment participants.

Left Navigation

• Assessments: Displays a card for each defined category. Each card shows the category name, a plus sign to add a General Risk Statement, the number of defined questions, a progress slider showing assessed questions, color-coded risk statement scores, and a button to view, continue, or start the assessment. In-progress assessments show buttons to Cancel or Finalize the assessment at the bottom of the window. Finalized assessments show an Archive Assessment button in the bottom right. Archived assessments are listed in the Versions section under the Archived Versions tab.
• Versions: Displays two tabs: Completed Assessment Versions and Archived Versions. Use the Completed Assessment Versions tab to compare different versions. Archived versions are deleted assessments.
• Critical Processes: Displays defined critical processes for the study. Top-right buttons and icons allow users to add, delete, import, or export critical processes, navigate the list (if multiple pages exist), and identify applied filters. 
• Critical Data: Displays defined critical data for the study. Top-right buttons and icons allow users to add, delete, import or export critical data, navigate the list (if multiple pages exist), and identify applied filters. 
• Risk Statements: Displays defined risk statements for the study. Top-right buttons and icons allow users to add, edit, or export risk statements, and identify applied filters. Displayed columns are defined during configuration. 
• Configuration: Displays a list of versions for a configured study assessment. Icons in the top right allow users to edit, approve, create a new version, and delete versions, and identify applied filters. 
• Start: Displays the Start date and time, and the user conducting the assessment in view.
• Finalize: Displays the Finalize date and time, and the user who conducted the assessment in view. Assessments not finalized will not display these details.

Print RACT Study Risk Assessment Summary Report

From Assessments users can open a printable RACT Study Risk Assessment Summary report. 

1. Click Assessments in the left navigation.
2. Select the Date of Assessment from the drop-down at the top of the window.
3. Click the Report icon at the top right. The selected Assessment Summary report will open in a new tab.
4. Use the Print button at the top right to print the report.