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 has been created and approved, and critical data and processes have been added. Risk Statements are reviewed and assessed during a Risk Assessment. Access to Risk Statements and Assessments are in the left navigation of the study specific landing page.  

Tip: It is recommended that critical data and processes are defined for a study prior to conducting an assessment.

Assessments use the currently approved version of the study assessment.

After the initial assessment is completed, interim assessments are completed based on how many weeks were defined in the assessment interval setting within study assessment configuration. The steps to complete an interim assessment follow what was in the initial assessment.  

Risk Statements

There are two types of risk statements:

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

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

General Risk Statements are defined for a category; however, they are not associated to any questions within a category. General risk statements should be reviewed during each assessment.

From a study specific landing page, click Risk Statements in the left navigation.

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

Fields in the new / edit forms will vary based on Risk Statement configuration.  

Add a Risk Statement

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

   Note: Fields with a red asterisk indicate entry is required.

2. Category: Select from the drop-down. If creating a new risk statement from the '+' on a category card, the Category will already be selected. If creating a new risk statement for a question, the Category field is not available.
3. If: Enter the event. Pull the bottom right corner to expand the entry field.
4. Due to: Enter the cause. Pull the bottom right corner to expand the entry field.
5. Then: Enter the impact. Pull the bottom right corner to expand the entry field.
   
   Details
6. Risk status: Select from Open, Realized & Closed, Realized & Open, or Not Realized & Closed.
7. Risk owner: Enter the risk owner.
8. Was the risk realized during this study?: Select from the drop-down: Yes / No / Not Applicable
9. Realization comment: Enter a comment.
   
   Risk Statement Scoring - Scoring selections become color coded once selected. 
   
   
10. Impact: Select Low, Medium, or High
11. Probability: Select Low, Medium, or High
12. Detectability: Select Easy, Medium, or Hard.
13. Critical Risk: Select Yes or No.
    The Overall Risk Statement Score (Low / Medium / High) displays based on your selections.
    
    Risk Statement Critical Data and Processes
14. No Critical Data or Process: Check this box If none are applicable.
15. Critical Data: Check the boxes of associated critical data.
16. Critical Process: Check the boxes of associated critical processes.
    
    

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

    
    Action Plan
17. Accept Risk: Click the Accept Risk button 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.
    To Edit or Delete the Accepted Risk, use the Edit / Delete icons.
18. Add Action Plan: Click the Add Action Plan button. The Action Plan window opens.
    
    Action Plan - Monitoring
19. Key Risk Indicators: Click the + next to Key Risk Indicators (KRIs) to select a KRI defined in RBQM (in Data Central) from the drop-down. 
20. Continue to click the + to add additional KRIs.
21. Quality Tolerance Limits: Click the + next to Quality Tolerance Limits (QTLs) to select a QTL defined in RBQM (in Data Central) from the drop-down.
22. Continue to click the + to add additional QTLs.
23. Delete: Click the trashcan icon to delete any unwanted KRIs or QTLs added.
    
    

    Tip: If KRIs and QTLs are not yet defined in RBQM, leave these fields blank and return to edit the fields 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.
25. Functional Plan: Select the Functional Plan from the drop-down.
26. Description: Enter a description. Pull the bottom right corner to expand the entry field.
27. Save: Click to save the Action Plan, or click Cancel to cancel your actions. The Action Plan window closes, and you return to the New Risk Statement window.
    
    More Details - Fields in this area will vary based on Risk Statement configuration.
28. Enter the details for each field using the functionality for the field. For example, use the date picker to select a date, or click the drop-down to select from a list.
29. Save: Click to save the risk statement, or click Cancel to cancel your actions.

Edit a Risk Statement from the list of Risk Statements

Risk statements can be edited using the same functionality as adding a new risk statement. 

1. Click on Risk Statements in the left navigation.
2. From the list of Risk Statements, click to highlight the row you wish to edit.
3. Click the Edit icon to open the Edit Risk Statement window.
4. Make changes.
5. Click Save.

Edit a Risk Statement from an Assessment Question

1. Click on Assessments in the left navigation.
2. During the conduct of an assessment, the Risk Statement Summary will list any added risk statements (left side of window). Highlight the row you wish to edit.
3. Make changes directly in each field (right side of window). Changes are saved automatically.
4. If updates have been made and the question review is complete, click the Complete button. An error message displays if all required fields have not been entered.

Conduct an Assessment

An Assessment uses the currently approved version of the study assessment. Assessments are conducted from the Assessments page.

If a study has not yet had their first assessment, the window will display with a Begin your first assessment button. Once the first assessment begins, assessments can continue or begin from a category card on the Assessments page.

Begin First Assessment

1. Click the Begin your first assessment button.
   

The list of Participants opens automatically to prompt entry of participant names. Enter the list of participants. 

Add Participants

1. If you are not automatically directed to the Participants list, click Participants at the top of the window.
2. Click the + Add Participant button.
3. Enter the First Name.
4. Enter the Last Name.
5. Enter their Role.
6. Click + Add Participant to add another participant.
7. Continue adding all participants. Updates are automatically saved.

Important: This list can be added to and modified during the assessment. No changes can be made after the risk assessment is finalized.

Edit Participants

1. Click in the field of the row you wish to edit.
2. Make the update. Updates are saved automatically.

Delete Participants

1. 1. Check the box at the left in the row of the participant(s) you wish to delete.
   2. Click the Delete Participants button.
   3. A confirmation window pops up. Click Yes.

Continue with the assessment. Click on Assessments in the left navigation, or if you are already on the Assessments page, click the Categories tab at the top of the window

 You can START the assessment from any category card.

Assessments Page Navigation

Review the navigation and functionality in the image below. The status of the current assessment displays.

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 the Studies 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: The start date and time when the assessment started, and the userid of the person who started it.
• Finalize Time / User: The date and time when the assessment was finalized, and the userid of the person who finalized it. No date / time displaying indicates the assessment is not final.

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

F. Categories / Participants tabs:

• The blue badges display the number of categories / participants defined for the study.
• Click the Categories tab to display the category cards for a study assessment.
• Click the Participants tab to display the participants for a study, as well as add, edit, and delete participants. Participants cannot be edited once an assessment has been finalized.

G. Assessments Page Header:

• Number of Risk Categories
• Number of Questions Completed

H. Name of Category: Click to access an action the questions within the category.

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

J. Questions Completed: A slider indicating the number of questions completed in the category.

K. Risk Statement Scores: Color coded markers displaying the number of risk statements with No Score, and Low, Medium, and High. 

L. Start / Continue / View: Click to access and action the questions within the category.

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

N. CANCEL ASSESSMENT: Click to cancel the assessment.

O. FINALIZE ASSESSMENT: Click to finalize the assessment.

Review Assessment Questions by Category

After adding participants, click on Assessments in the left navigation, or the Categories tab to return to the Assessments page. Each category defined for the study displays a card. Cards display 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 on 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 listing Study ID, Version, how many questions and risk statements are in the assessment and in each category, as well as navigate to other categories, questions, and risk statements. The category and question currently being viewed is 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 displays. 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 may vary based on Risk Statement configuration.
• Risk Status: Select from drop-down
• Risk owner: Enter
• Was the risk realized during this study?: Select from drop-down
• Realization comment: Enter
• Scoring: Impact / Probability / Detectability: Select buttons (button are color coded based on selection)
• Overall Risk Statement Score: System generated, and color coded based on risk
• Critical Risk: Select from drop-down
• Critical Data and Processes: Select appropriate checkbox(es), add critical data / process
• Action Plan: Add Action Plan, or Accept Risk
• More Details: Complete all required questions

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 the risk statements from the Risk Statement Summary section and click in the Question Not Applicable checkbox. The Complete button at the top right changes to a green checkmark Question Completed.
3. The details of the highlighted risk statement display at the right. Read and review each field and make any necessary updates, answer questions, and add Action Plans as appropriate. Use the scrollbar on the right to access all fields. Fields with red asterisks are required to be completed. 
   

   Note: If Critical Data or Critical Processes need to be added during Risk Statement review for a question, use the Add Critical Data / Add Critical Process button within the Risk Statement, or 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 on the delete icon in the Risk Statement Summary section. 
6. After the question is reviewed and all updates have been made, click the Complete button at the top right. An error message displays 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 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.