Configuring Risk Based Study Management (CTMS)

Risk Based Study Management RBSM allows users to apply risk-based practices to study management. This functionality is available in all CTMS Vaults but requires some configuration to be accessed by users.

Configuration Overview

  • Add the following related object sections to page layouts:
    • Study Risk Assessment to the Study object’s page layout.
    • Study Risk, Study Risk Mitigation, Study Critical Data, and Study Critical Process to the Study Risk Assessment object’s page layout.
    • Risk Mitigation to the Risk object’s page layout.
    • Optional: Risk Mitigation, Study Risk Critical Data, and Study Risk Critical Process to the Study Risk object’s page layout.
  • Add the Generate Risk Assessment user action to the Study Lifecycle on the Study object to one or more lifecycle states.
  • Activate the Risk Mitigation Action object type on the Issue (pdvd__ctms) object.
  • Configure fields on the Issue (pdv__ctms) to make relevant fields optional for the Risk Mitigation Action object type.
  • Activate the Risk Action Owner Application Role.
  • Activate the Risk Mitigation Library tab.
  • Update permission sets to grant users access to the risk-related objects and navigation tabs.
  • Optional: Configure lifecycles and workflows for the review and approval of Risk Assessment Templates or Study Risk Assessments.
  • Optional: Add additonal fields to risk-related objects to fit your organization’s needs.

Download & Import the Risk Assessment & Categorization Tool

We recommend using the Risk Assessment & Categorization Tool (RACT) as a starting point for your Risk Library to populate your Vault with industry-standard Risks, Risk Categories, and Risk Assessment Templates. To do this, import and deploy a Configuration Migration Package:

  1. Download the ZIP file here.
  2. Import and Deploy the ZIP file in your Vault.

Configuring the Study Risk Score Symbols

Vault displays a Risk Symbol for each Study Risk based on the study’s Risk Score. The default thresholds for each symbol are:

Status

Risk Symbol

Risk Score

Pending Assessment

Pending Assessment Symbol

= 0

Low Risk

Low Risk Score Symbol

< 5

Medium Risk

Medium Risk Score Symbol

< 10

High Risk

High Risk Score Symbol

>= 10

To change the values that determine the thresholds for each symbol:

  1. Navigate to Admin > Configuration > Objects > Study Risk > Fields > Risk Symbol.
  2. Click Edit.
  3. Modify the Formula Expression by changing the thresholds (in bold below) that determine which symbol is displayed: if(risk_score__v=0,icon("minus", "#A9A9A9", "Pending Assessment"),if(risk_score__v<5,icon("check", "#008000", "Low Risk"),if(risk_score__v<10,icon("exclamation-triangle", "#ffa500", "Medium Risk"),if(risk_score__v>=10,icon("exclamation-circle", "#ff0000", "High Risk"),icon("minus", "#A9A9A9", "Pending Assessment")))))

You can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner profile.

If your Vault uses custom security profiles, your profile must grant the following permissions:

Type

Permission Label

Controls

Security Profile Admin: Objects: Edit

Ability to edit object details and page layouts.

Security Profile
 Admin: Object Lifecycles: Edit

Ability to configure object lifecycles.
Security Profile
 Admin: Object Workflows: Edit

Ability to configure object workflows.
Security Profile
 Admin: Permission Sets: Read, Create, Edit, Delete

Ability to configure Permission Sets.
Security Profile
 Admin: Migration Packages: Deploy

Ability to deploy packages for configuration migration; you'll need this permission on the target Vault.