# Configuring Risk Based Study Management (RBSM)

Risk Based Study Management [RBSM](/en/lr/62007/) 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](/en/lr/26387/#related-object) 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](/en/lr/59885/#user-actions) to the _Study Lifecycle_ on the _Study_ object to one or more lifecycle states.
  * [Activate](/en/lr/32857/#create) the _Risk Mitigation Action_ object type on the [_Issue_](/en/lr/68403/) (`pdvd__ctms`) object.
  * Configure fields on the [_Issue_](/en/lr/68403/) (`pdv__ctms`) to make relevant fields optional for the _Risk Mitigation Action_ object type.
  * Activate the _Risk Action Owner [Application Role](/en/lr/31851/#application-role)_.
  * Activate the _Risk Mitigation Library_ tab.
  * [Update permission sets][4] to grant users access to the risk-related objects and navigation tabs.
  * Optional: Configure [lifecycles](/en/lr/30683/) and [workflows](/en/lr/33550/) for the review and approval of _Risk Assessment Templates_ or _Study Risk Assessments_.
  * Optional: [Add additonal fields](/en/lr/15057/#add-fields) to risk-related objects to fit your organization's needs.

## Download & Import the Risk Assessment & Categorization Tool {#RACT}

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. <a class="download-link " href="https://platform.veevavault.help/assets/downloads/ctms-ract-records.zip" target="_blank" rel="noopener">Download the ZIP file here<i class="fa fa-download" aria-hidden="true"></i></a>.
  2. [Import](/en/lr/36919/#import) and [Deploy](/en/lr/36919/#deploy) the ZIP file in your Vault.

## Configuring the Study Risk Score Symbols {#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:

<table class="wbord">
  <tr>
    <td>
      <p>
        <strong>Status</strong>
      </p>
    </td>
    <td>
      <p>
        <strong>Risk Symbol</strong>
      </p>
    </td>
    <td>
      <p>
        <strong>Risk Score</strong>
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Pending Assessment
      </p>
    </td>
    <td>
      <img class="inline" src="https://platform.veevavault.help/assets/images/ctms-pending-risk-score.png" alt="Pending Assessment Symbol" style="" />
    </td>
    <td>
      <p style="text-align: center;">
        = 0
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Low Risk
      </p>
    </td>
    <td>
      <img class="inline" src="https://platform.veevavault.help/assets/images/ctms-low-risk-score.png" alt="Low Risk Score Symbol" style="" />
    </td>
    <td style="text-align: center;">
      <p>
        < 5
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Medium Risk
      </p>
    </td>
    <td>
      <img class="inline" src="https://platform.veevavault.help/assets/images/ctms-medium-risk-score.png" alt="Medium Risk Score Symbol" style="" />
    </td>
    <td style="text-align: center;">
      <p>
        < 10
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        High Risk
      </p>
    </td>
    <td>
      <img class="inline" src="https://platform.veevavault.help/assets/images/ctms-high-risk-score.png" alt="High Risk Score Symbol" style="" />
    </td>
    <td style="text-align: center;">
      <p>
        >= 10
      </p>
    </td>
  </tr>
</table>

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")))))`

## Related Permissions {#related-permissions}

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](/en/lr/22824/):

<table class="wbord">
  <tr class="alt-table-row">
    <td style="width: 91px;">
      <p>
        <strong>Type</strong>
      </p>
    </td>
    <td style="width: 179px;">
      <p>
        <strong>Permission Label</strong>
      </p>
    </td>
    <td style="width: 350px;">
      <p>
        <strong>Controls</strong>
      </p>
    </td>
  </tr>
  <tr>
    <td style="width: 91px;">
      Security Profile
    </td>
    <td style="width: 179px;">
      Admin: Objects: Edit
    </td>
    <td style="width: 350px;">
      <p>
        Ability to edit object details and page layouts.
      </p>
    </td>
  </tr>
  <tr>
    <td style="width: 91px;">
      Security Profile<br>
    </td>
    <td style="width: 179px;">
      Admin: Object Lifecycles: Edit<br>
    </td>
    <td style="width: 350px;">
      <p>
        Ability to configure object lifecycles.<br>
      </p>
    </td>
  </tr>
  <tr>
    <td style="width: 91px;">
      Security Profile<br>
    </td>
    <td style="width: 179px;">
      Admin: Object Workflows: Edit<br>
    </td>
    <td style="width: 350px;">
      <p>
        Ability to configure object workflows.<br>
      </p>
    </td>
  </tr>
  <tr>
    <td style="width: 91px;">
      Security Profile<br>
    </td>
    <td style="width: 179px;">
      Admin: Permission Sets: Read, Create, Edit, Delete<br>
    </td>
    <td style="width: 350px;">
      <p>
        Ability to configure Permission Sets.<br>
      </p>
    </td>
  </tr>
  <tr>
    <td style="width: 91px;">
      Security Profile<br>
    </td>
    <td style="width: 179px;">
      Admin: Migration Packages: Deploy<br>
    </td>
    <td style="width: 350px;">
      <p>
        Ability to deploy packages for configuration migration; you'll need this permission on the target Vault.<br>
      </p>
    </td>
  </tr>
</table>

 [4]: #related-permissions