Overview of the Risk Assessment and Categorization Tool (RACT)

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 RACT (Risk Assessment and Categorization Tool) supports the initial and ongoing assessment and categorization of risk to a clinical study and documents the action plans that the study team has adopted to address those risks.

The RACT has the following features:

Assess initial study risks and revisit them on a regular basis with interim assessments.
Identify and track Critical Data and Processes, and link identified study risks to the relevant critical items.
Review the identified risk to a study and assessment scores, and gain risk insights through analysis of past assessments.
Manage study assessments and update the study specific assessment tools.
Manage Assessment Questions, Categories, Functional Plans, Response Strategies, and Risk Statements to tailor the RACT experience to meet your existing business process.

The Risk Assessment & Categorization Tool (RACT) is 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. After a study assessment is approved, the study team meets to conduct the Initial Assessment. After the initial assessment, adjustments can be made, and the study team continues with ongoing assessments.

Risk Assessment Studies Landing Page

All studies that are RACT enabled are listed in the RACT Landing Page. The number of studies in the list displays in the blue badge, and columns in the list can be sorted and fixed.

Columns include the Study name, which is a hyperlink to the study specific landing page, Status, Last Assessment Date, and Next Assessment Due Date. Users with the RACT Configure privilege will see the configuration icon at the top right.

Statuses can be:

Not Started: The initial study assessment has not yet 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 all studies, a user can access a study specific landing page by clicking on the study name.

Study Specific Landing Page

Across the Top

The Master Header is at the top of the window that includes the 9-dot icon to open the Platform Menu, the elluminate logomark that when clicked returns you to the Studies Home Page, where you are within elluminate, and at the far right access to the Help menu.

Just below the Master Header is a left facing arrow that when clicked returns you to the RACT Landing Page.

Click on 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 items across the top vary based on which item is selected in the left navigation. For example, in the screenshot above Assessments is selected. Depending on the status of the study assessment, users are brought to Assessments or Configuration. If a study assessment is Approved, users automatically go to Assessments. If a study assessment is In Development or Not Started, users automatically go to Configuration. In the screenshot above notice Assessments has an orange bar at the left and is highlighted indicating where in the study you are.

Left Navigation

Assessments: View a card for each defined category. Each card displays the name of the category, a plus sign to add a General Risk Statement, how many questions have been defined, a progress slider displaying how many questions have been assessed, color coded risk statement scores, and a button to view, continue, or start the assessment. Assessments in progress will have buttons at the bottom of the window to Cancel Assessment or Finalize Assessment.
Versions: Displays a list of Completed Assessment Versions. Each column can be sorted and filtered. The number in the blue badge indicates how many versions are in the filtered listed. Use this list to Compare different versions.
Critical Processes: Displays a list of defined critical processes for the study. Users can use the buttons and icons at the top right to add or delete a critical process, move through the list (if there are multiple pages), and identify if filters are applied. Columns include Title and Description. Columns can be sorted, fixed, and filtered. The number in the blue badge indicates how many rows are in the filtered list.
Critical Data: Displays a list of defined critical data for the study. Users can use the buttons and icons at the top right to add or delete critical data, move through the list (if there are multiple pages), and identify if filters are applied. Columns include Title and Description. Columns can be sorted, fixed, and filtered. The number in the blue badge indicates how many rows are in the filtered list.
Risk Statements: Displays a list of defined risk statements for the study. Users can use the buttons and icons at the top right to add or edit a risk statement. Columns displayed are defined during configuration and may include the Risk Statement, Category, Risk Status, Risk Owner, Risk Realized?, Realization Comment, Risk Score Summary, and Critical Risk. The number in the blue badge indicates how many rows are in the filtered list.
Configuration: Displays a list of versions for a configured study assessment. Users can use the icons at the top right to add, edit, approve, create a new version, delete, and identify if filters are applied. Columns include Version number, Last Modified Date, Last Modified By, Comments, and Status.
Start: See the Start date and time, and the user conducting the assessment in view.
Finalize: See the Finalize date and time, and 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.