Permissions: Users with the RACT Assessment Read Write or RACT Configure privilege can manage Risk Statements and conduct Assessments for a study.
Users with the RACT Assessment Read Only privilege can view RACT data to participate in study assessment activities.

Assessments are conducted after a study assessment is created and approved, and critical data and processes are added. Risk Statements are reviewed and assessed during a Risk Assessment. Access to Risk Statements and Assessments is available in the left navigation of the study-specific landing page.  

Tip: It is recommended that critical data and processes be defined for a study before conducting an assessment.

Assessments use the currently approved version of the study assessment.

After the initial assessment, interim assessments are completed based on the number of weeks defined in the assessment interval setting within the study assessment configuration. The steps for completing an interim assessment follow those of the initial assessment.  

Risk Statements

There are two types of risk statements:

1. General Risk Statements are associated with a category but not with a specific question. They are added and managed from the Risk Statements page or added via the '+' icon on the Category card when viewing Assessments.

2. Question-specific Risk Statements are associated with a specific question and are added and managed directly during an Assessment. Risk Statements added within a question also appear in the list of Risk Statements.

General Risk Statements are defined for a category but not associated with any questions within that category. These statements should be reviewed during each assessment.

To view risk statements, go to the study-specific landing page and click Risk Statements in the left navigation.

This displays the list of existing risk statements (if any) for a study. The number in the blue badge indicates the number of rows in the filtered list. Use the icons at the top right to add a new general risk statement, edit an existing one, export the list, and identify if filters have been applied. Clicking the add or edit icons opens the New / Edit Risk Statement window.

The fields in the new / edit forms vary depending on the Risk Statement configuration.  

Add a Risk Statement

1. Click the Add General Risk Statement icon from the Risk Statements page, or the + sign on an Assessment Category card. The New Risk Statement window will open.
   
   

   Note: Fields with a red asterisk indicate entry is required. Use the scrollbar to access all fields.

2. Category: Select from the drop-down menu. If creating a new risk statement using the '+' on a category card, the Category will be pre-selected. This field is unavailable when creating a risk statement for a specific question.
3. If: Enter the event. The entry field can be expanded by dragging its bottom-right corner.
4. Due to: Enter the cause. The entry field can be expanded by dragging its bottom-right corner.
5. Then: Enter the impact. The entry field can be expanded by dragging its bottom-right corner.
   
   Details
6. Risk status: Select from: Open, Realized & Closed, Realized & Open, or Not Realized & Closed.
7. Risk owner: Enter the risk owner's name.
8. Was the risk realized during this study?: Select from the drop-down menu: Yes / No / Not Applicable
9. Realization comment: Enter a comment. The entry field can be expanded by dragging its bottom-right corner.
   
   Risk Statement Scoring - Scoring selections are color-coded after selection.
   
   
10. Impact: How serious will the impact of the risk be if it becomes an issue? Select Low, Medium, or High.
11. Probability: How probable is it that the risk will become an issue? Select Low, Medium, or High.
12. Detectability: How difficult is it to detect the risk in enough time to act before it becomes an issue? Select Easy, Medium, or Hard.
    The Overall Risk Statement Score (Low / Medium / High) will display based on your selections.
13. Critical Risk: Select Yes or No.
    
    Risk Statement Critical Data and Processes
14. No Critical Data or Process: Check this box If none apply.
15. Critical Data: Select the associated critical data.
16. Critical Processes: Select the associated critical processes.
    
    

    Tip: To add additional critical data or processes to the Risk Statement, click the Add Critical Data / Add Critical Process button, enter the Title and Description, and click Save.

    
    Action Plan - The action plan for addressing the risk.
17. Accept Risk: Click Accept Risk to accept the risk. Add an additional note in the pop-up and click Accept Risk. If this is checked, skip the Action Plan details, and move to More Details.
    Use the Edit / Delete icons to modify or remove the accepted risk.
18. Add Action Plan: Click Add Action Plan to open the Action Plan window.
    
    Action Plan - Monitoring
19. Key Risk Indicators: Click the + icon next to Key Risk Indicators (KRIs) to select a KRI from the drop-down menu (KRIs are defined in RBQM within Data Central). 
20. Click the + icon repeatedly to add multiple KRIs.
21. Quality Tolerance Limits: Click the + icon next to Quality Tolerance Limits (QTLs) to select a QTL from the drop-down menu (QTLs are defined in RBQM within Data Central).
22. Click the + icon repeatedly to add multiple QTLs.
23. Delete: Click the trashcan icon to delete any unwanted KRIs or QTLs.
    
    

    Tip: If KRIs and QTLs are not yet defined in RBQM, leave these fields blank and return to edit them after they have been configured in RBQM.

    
    Action Plan - Response Strategy and Functional Plan
24. Response Strategy: Select the Response Strategy from the drop-down menu.
25. Functional Plan: Select the Functional Plan from the drop-down menu.
26. Description: Enter a description. The entry field can be expanded by dragging its bottom-right corner.
27. Save: Click Save to save the Action Plan, or Cancel to discard changes. This will close the Action Plan window and return you to the New Risk Statement window.
    
    More Details - The fields in this section will vary based on the Risk Statement configuration.
28. Use the appropriate functionality for each field ( e.g., date picker, drop-down menu).
29. Save: Click Save to save the risk statement, or Cancel to discard changes.

Edit a Risk Statement from the list of Risk Statements

Risk statements are edited using the same functionality as for adding new risk statements. 

1. Click Risk Statements in the left navigation.
2. Select the Risk Statement you want to edit from the list.
3. Click the Edit icon to open the Edit Risk Statement window.
4. Make your changes.
5. Click Save.

Edit a Risk Statement from an Assessment Question

1. Click Assessments in the left navigation.
2. During the conduct of an assessment, the Risk Statement Summary (on the left) will list any added risk statements. Select the statement you wish to edit.
3. Make changes directly in the fields on the right. Changes are saved automatically.
4. Once updates are complete and the question review is finished, click Complete. An error message will appear if any required fields are missing.

Conduct an Assessment

Assessments use the currently approved version of the study assessment and are conducted from the Assessments page.

If a study has not yet had their first assessment, the page will display a Begin your first assessment button. After the first assessment begins, subsequent assessments can be started either from the Assessments page or from a category card on that page.

Begin First Assessment

1. Click Begin your first assessment.
   

A list of Participants will automatically open, prompting you to enter participant names. 

Add Participants

1. If the Participants list doesn't automatically open, click Participants at the top of the window.
2. Click+ Add Participant.
3. Enter the First Name.
4. Enter the Last Name.
5. Enter their Role.
6. Click + Add Participant to add more participants.
7. Repeat step 6 until all participants are added. Changes are automatically saved.

Important: This participant list can be added to and modified during the assessment; however, no changes are allowed after the risk assessment is finalized.

Edit Participants

1. Click in the field of the row you wish to edit.
2. Make your changes; updates are saved automatically.

Delete Participants

1. 1. Check the box to the left of each participant you wish to delete.
   2. Click the Delete Participants button.
   3. Click Yes to confirm in the pop-up window.

To continue the assessment, either click Assessments in the left navigation or, if already on the Assessments page, click the Categories tab at the top

 You can START the assessment from any category card.

Assessments Page Navigation

The image below shows the navigation, functionality, and current assessment status.

A. elluminate master header: 

• 9-dot icon: Click the 9-dot icon to open the Platform Menu.
• elluminate logomark: Click the elluminate logomark to return to your default landing page.
• User location: Risk Assessment & Categorization Tool > Assessments: where you are in the system.
• Help icon: Click the question mark icon to access the Help Menu.

B. Back to all Studies / Study

• Click the Back to all Studies arrow to return to the RACT Landing Page.
• Current Study: the current study displays. Click the down arrow to select a different study.

C. Assessments: Indicates the Assessments page is in view for the selected study.

D. Start / Finalize

• Start Time / User: Displays the assessment's start date, time, and the userid of the person who initiated it.
• Finalize Time / User: Displays the assessment's completion date, time, and the userid of the person who finalized it. The absence of a date and time indicates that the assessment is not yet finalized.

E. Current Assessment Start Date, Time, and Version: Click the down arrow to select a different assessment (if available).

F. Categories / Participants tabs:

• Blue badges indicate the number of categories / participants defined for the study.
• Click the Categories tab to view the category cards for a study assessment.
• Click the Participants tab to view, add, edit, or delete participants. Note that participants cannot be edited after an assessment is finalized.

G. Assessments Page Header:

• Number of Risk Categories: Displays the total number of risk categories.
• Number of Questions Completed: Displays the total number of completed questions.

H. Name of Category: Click a category name to open the questions associated with that category.

I. +: Click the '+' icon to add a new General Risk Statement. See section Add a Risk Statement.

J. Questions Completed: Use the slider to view the number of questions completed in the category.

K. Risk Statement Scores: Observe the color-coded markers that indicate the number of risk statements with No Score, as well as those scored as Low, Medium, and High. 

L. Start / Continue / View: Click this button to open the questions within the category.

M. Report icon: Click the report icon to open the Assessment Summary in a new tab.

N. CANCEL ASSESSMENT: Click this button to cancel the assessment.

O. FINALIZE ASSESSMENT: Click this button to finalize the assessment.

Note: Finalized assessments will have an ARCHIVE ASSESSMENT button in the bottom-right corner. This is typically used to remove assessments that were done in error. Once archived, they cannot be edited. For details on how to archive an assessment, visit this section: Archive an Assessment

Review Assessment Questions by Category

After adding participants, click Assessments in the left navigation or the Categories tab to return to the Assessments page. Each category defined for the study displays a card, which includes a button at the bottom to START the category assessment, CONTINUE reviewing questions not marked as complete, or VIEW completed questions.

To begin reviewing the questions within a category, click START at the bottom of a category card.

Assessment Question Navigation

Review the navigation and functionality below.

A. Back Arrow: Click to return to the study assessment page.

B. Assessment Summary drop-down / Category Name: Click to open a drop-down that lists the Study ID, Version, the number of questions, and risk statements in the assessment and in each category. You can also navigate to other categories, questions, and risk statements. The category and question currently being viewed are highlighted. Click to select a different question or go to General Risk Statements for that Category.

C. Category / Question Navigation, Study Name, Number of Questions:

• Previous Page / Category: Use the arrows to go to a previous question or category.
• Study Name
• Question n of n
• Next Page / Category: Use the arrows to go to the next question or category.

D. Complete: Click to complete the question. If the question is not marked as Not Applicable, no risk statements are added, or the risk statement is missing required fields, a warning message will display. Close the message and continue to complete the question. All required fields must be completed.

E. The Question: Read and review the question with the team. 

F. Question Not Applicable: Click the checkbox if appropriate. The Complete button will be updated to Completed. Go to the next question.

G. Risk Statement Summary: Any Risk Statements already added for the question display. Click to highlight a risk statement and the details display at the right of the window. 

H. Add / Delete icons: Click to add or delete a risk statement. See section Add a Risk Statement for details. To delete a risk statement, highlight the Risk Statement and click the Delete icon.

I. Risk Statements: Use this window to enter / edit risk statement details, and review with team. 

• Risk Statement: If / Due to / Then May result.
• Details: Fields vary based on Risk Statement configuration.
  • Risk Status: Select from drop-down menu.
  • Risk owner: Enter the risk owner.
  • Was the risk realized during this study?: Select from drop-down menu.
  • Realization comment: Enter a realization comment.
• Scoring: Impact / Probability / Detectability: Select the appropriate button (buttons are color coded based on selection).
  • Overall Risk Statement Score: System generated, and color coded based on risk.
• Critical Risk: Select from drop-down menu.
• Custom fields: If a custom field is available, hover over the 'i' for details and enter the field information accordingly.
• Critical Data and Processes: Select the appropriate checkbox(es) and add critical data or processes if needed.
• Action Plan: Add an Action Plan, or Accept Risk.
• More Details: Complete all required fields.

Question Review Workflow

1. Review a question with the team. Any risk statement(s) already defined for the category display in the Risk Statement Summary below the question.
2. If the question is not applicable, delete all the risk statements from the Risk Statement Summary section and click the Question Not Applicable checkbox. The Complete button in the top right corner changes to a checkmark, and displays Question Completed.
3. The details of the highlighted risk statement display on the right. Read and review each field, make any necessary updates, answer questions, and add Action Plans as appropriate. Use the scrollbar on the right to access all fields. Fields marked with red asterisks are required to be completed. 
   

   Note: If Critical Data or Critical Processes need to be added during the Risk Statement review for a question, use the Add Critical Data / Add Critical Process button within the Risk Statement. Alternatively, you can return to the study landing page, go to Critical Data or Critical Processes in the left navigation, and add the critical data or process.

4. If needed, add new risk statement(s) by clicking on the '+' in the Risk Statement Summary section.
5. If appropriate, delete a risk statement by clicking the delete icon in the Risk Statement Summary section. 
6. After reviewing the question and making all necessary updates, click the Complete button at the top right. An error message will display if all required fields have not been completed.
7. Click the Next button to move to the next question.
8. Review all questions and general risk statements for each category. 

Finalize an Assessment

After all questions and general risk statements have been reviewed and participants have been added, the assessment can be finalized.

1. Click the FINALIZE ASSESSMENT button in the bottom right corner. 

   Note: A highlighted statement displays if the assessment is incomplete. Read the statement and action noted items. Technically, an incomplete assessment can be finalized.

   
2. Confirm the Risk Assessment Version Details.
3. In the Additional Version Details section, enter the Version Name.
4. Enter the Version Description.
5. By default, Finalize and start a new version of the assessment is checked. If you uncheck this, you can start the next assessment manually.
6. Click the Finalize button. Or click the Close button to exit this window.

Archive an Assessment

Finalized assessments can be archived. Archiving will delete the assessment, making it no longer editable. This process is typically used to remove assessments that were done in error or are obsolete. A list of archived versions is available on the Versions page under the Archived Versions tab.

1. Access the finalized assessment you wish to archive.
2. Click the Assessment Version drop-down in the top left corner and select the finalized version.
3. Click the ARCHIVE ASESSMENT button in the bottom right corner. An Archive Assessment window will open.
4. Enter the reason for archiving.
5. Click the Archive Assessment button, or click Cancel to cancel your action. A confirmation message will be displayed.