Configuring Risk Management Program (RMP)

Creating Risk Identification Forms

Perform the following steps, to create Risk Identification Form:

1. Create codelist and codelist values for the field Reason Unable to Link using the standard method to create a new codelist from Admin à Setup à Codelist.

2. On the Setup menu, select Risk Management à RI/RA Form Maintenance.
   RI/RA Form Selection page appears.

3. Click Create New in the RI/RA Form Selection screen.

Or

Click Add in the RI/RA Form Search Result screen, to create the new RI/RA Form.

The RI/RA Form Maintenance page appears.

4. Enter Form Name and Form name Japanese (If applicable).

5. Select Form Type as Risk identification.

6. Click Save.

7. Click OK on confirmation window. On click of OK, the New button gets enabled.

8. Click New to define field(s) details for the RI form. The RI/RA Field Maintenance screen appears.

9. Enter the field details.

10. Click Save.

11. Click OK on the confirmation window and then close the window.

12. Repeat steps from 8 and 9 for adding more fields for the RI form.

To edit the risk identification fields, click icon and make necessary changes and click Save.

Note: If the form is associated to a case, the application does not allows you to modify the codelist ID (Codelist Name) and the data type fields (Field type).

To delete risk identification fields, select the check box adjacent to the fields and click Delete.  If the risk identification fields are associated with any case, then you cannot delete them.

Field Description of Risk Management field Maintenance

Creating Risk Assessment Forms

The risk assessment is performed on completion of case processing.

Perform the following steps, to create Risk Assessment Form:

1. Create codelist and codelist values for all the dynamic fields using the standard method to create a new codelist from Admin à Setup à Codelist.

2. On the Setup menu, select Risk Management à RI/RA Form Maintenance.
   RI/RA Form Selection page appears.

3. Click Create New in the RI/RA Form Selection screen.

Or

Click Add link in the RI/RA Form Search Result screen, to create the new RI/RA Form.

RI/RA Form Maintenance screen appears.

4. Enter Form Name and Form name Japanese (if applicable).

5. Enter Form Type as Risk Assessment.

6. Click Save.

7. Click OK on confirmation window. On click of OK button, the New button gets enabled as shown below.

8. Click New to define field(s) details for the RA form. RI/RA Field Maintenance screen appears.

9. Click Save.

10. Click OK on the confirmation window and then close the window.

11. Repeat steps from 8 and 9 for adding more fields for the RA form.

To edit the risk assessments fields, click icon and make necessary changes and click Save.

To delete risk assessments fields, select the check box adjacent to the fields and click Delete. If the risk identification fields are associated with any case, then you cannot delete them. 

Field Description of Risk Management field Maintenance

Risk Management Program Setup

Once the Risk Identification and Risk Assessment Forms are created, the user can set up a Risk Management Program by associating it with the appropriate RI or RA form (or both) and defining Product(s) and Role(s) for using the REMS program in the application.  

Steps for RMP Setup:

• Define RMP

• Attach Products

• Assign Roles

Define RMP

1. On the Setup menu, select Risk Management à Risk Management Program. The Risk Management Program Selection page appears

2. Click Create New on the Risk Management Program Selection screen.

Or

Click Add on the RMP Search Result screen to create a new Risk Management Program.

3. Click Save.

On click of save button, the Product section gets enabled to add a product(s).  

Attach Product

Next: Refer Attach Product for associating single or multiple product(s) to this RMP.

1. Click Add to associate product with RMP. The Product lookup screen appears.

2. Click  icon to search for the product name from the CPD Lookup window. Click OK in the CPD Lookup window.

3. Search for the products marked as "Subject to Risk Management” or using any other criteria displayed in Level 1 and Level2 of the CPD Lookup window.

4. Select a product from the list and click Select. The selected product gets displayed in the Product Name field of the Product lookup screen.

5. Click Save.

6. Click OK on the confirmation window.

7. Click Back to redirect to the Risk Management Maintenance page.

8. Click Add to add multiple products without going back to the main Risk Management Maintenance page every time.

9. Repeat the 8th step to add more products.

Next: Refer Assign Roles to RMP section for giving role privileges to this RMP.

Note:  The application also allows for manual text entry of a product name in the "Product Name” field for attaching product to an RMP which is not defined in CPD.

To delete products, select the check box adjacent to the field(s) and click Delete.

Assign Role to RMP

1. Select the roles from the Available roles section to associate various user roles, for accessing the risk management program.

2. Add the roles to the Assigned roles section.

1. Click Save to save the assigned user roles.

Note: By default, Admin and Setup roles can access the risk management program maintenance page.

Field Description of Risk Management Program Maintenance