# Using Risk Based Study Management (RBSM) Risk Based Study Management (RBSM) gives you the ability to apply risk-based practices to study management. Track risk _Impact_, _Probability_, _Detectability_, and an _Overall Risk Score_ to understand specific areas of risk within your study. This functionality is available in all CTMS Vaults but requires some configuration by your Admin for utilization.
## Risk Library The Risk Library is a repository of universal risks used to create risk assessment templates and study-specific risks. Create universal _Risk_, _Risk Category,_ and _Risk Assessment Template_ records in your Risk Library to re-use across multiple studies. When you apply risks from your Risk Library to a study, Vault creates study-specific risks that can be modified, scored, reviewed, and approved by the study team. Navigate to your **Risk Library** from the **Risk Management** tab. We recommend that your Admin import and deploy 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_. ### Related Objects * **Risk Category**: Defines the category and default scoring weight of risks. Use _Category Weight_ to specify the relative importance of one category to another. * **Risk**: Defines universal _Discussion Points_ and _Considerations_ for risks at the study, country, or site level. * **Risk Mitigation**: Defines universal _Mitigation Actions_ at the study, country, or site level that you can apply to risks. * **Risk Assessment Template**: A collection of _Risks_ from the Risk Library that you can apply to multiple studies using the _Generate Risk Assessment_ action. Use templates for a specific purpose. For example, you may create one template for a particular therapeutic area and another template for a study phase. ### How to Create Risk Categories 1. Create and edit risk categories from the **Risk Management > Risk Categories** tab. 2. Click **Create > Risk Category** to create a new _Risk Category_ or click on a _Risk Category_ to edit an existing record. 3. Enter a _Category Name_ for the _Risk Category_. 4. Optional: Enter a _Category Weight_ value less than or equal to "1". 5. Click **Save**. ### How to Create Risks 1. Create and edit risks from the **Risk Management > Risk Library** tab. 2. Click **Create > Risk** to create a new _Risk_ or click on a _Risk_ to edit an existing record. 3. Enter the details of the _Risk_ record, including the _Short Description_, _Risk Category_, _Level_, _Discussion Points_, and _Considerations_. 4. Optional: **Add** [_Risk Mitigations_][3]. 5. Click **Save**. ### Risk Assessment Templates _Risk Assessment Templates_ are a collection of _Risks_ for a particular purpose. You can create templates for specific phases or therapeutic areas of a study, or create universal risk assessment templates to be used across all studies. You can apply templates to multiple studies, at which point the risks and mitigations become [study-specific][4]. To create a _Risk Assessment Template_: 1. Navigate to **Risk Management > Risk Assessment Template > Create > Risk Assessment Template**. 2. Enter a _Name_ for the template. 3. Click **Save**. 4. Click **Add** to add active _Risks_ from your Risk Library to the template. 5. Select the _Risks_ that you want to add to the template. 6. Optional: Click on **Create** to create new _Risk_ records for your Risk Library. 7. Click **OK**. You can only apply risk assessment templates in the _Approved_ state to studies. To approve a _Risk Assessment Template_, navigate to the record, click on the **Action** menu, and select **Approve**. ## Risk Mitigation Library {#risk-mitigation-library} The Risk Mitigation Library is a repository of _Risk Mitigations_. Risk Mitigations in Veeva CTMS are the actions taken in order to prevent a risk from occurring. You can create standard _Risk Mitigations_ in your Risk Mitigation Library and relate them to _Risks_ in your Risk Library. When you apply _Risks_ to a study in a _Study Risk Assessment_, Vault creates study-specific risks and related study-specific mitigations. Navigate to your **Risk Mitigation Library** from the **Risk Management** tab. ### How to Create Risk Mitigations 1. Create and edit risk mitigations from the **Risk Management > Risk Mitigation Library** tab. 2. Click **Create > Risk Mitigation** to create a new _Risk Mitigation_ or click on a _Risk Mitigation_ to edit an existing record. 3. Enter the record details. 4. Optional: select a **Role Responsible** that Vault will assign the mitigation to for the selected **Mitigation Level**. 5. Click **Save**. Depending on the configuration of your Vault, the _Risk Mitigation_ may need to go through review and approval lifecycles or workflows . ## Study Risk Assessments {#study-risk-assessments} You can track, change, review, and approve study-specific risks by assigning risks to a _Study Risk Assessment_. Vault calculates an [_Overall Risk Score_][7] for each _Study Risk Assessment_ based on the weighted scores of the [_Study Risk Categories_][8] and [_Study Risks_][9] within the study-specific assessment. A given _Study_ can only have one (1) _Study Risk Assessment_. You can create a _Study Risk Assessment_ by: * Applying risk assessment templates or an existing _Study Risk Assessment_ record to a study via the [**Generate Risk Assessment** action][10]. * Creating a [new _Study Risk Assessment_][11] in the _Study_ record. ### Related Objects * **Study Risk Category**: Stores the risk categories, category scoring weight, and category risk scores for a study. * **Study Risk**: Contains _Risk_ details from your Risk Library such as _Discussion Points_ and _Considerations_ and study-specific details such as the _Impact_, _Probability_, _Detectability_, and _Risk Score_. * **Study Risk Mitigation**: Captures a study-specific risk mitigation and the action that has been or will be taken to fulfill the mitigation. * **Study Risk Assessment**: A collection of study-specific _Study Risk_ records with an _Overall Risk Score_. * **Study Critical Data**: Captures data points critical to study execution that can relate to _Study Risks_. * **Study Critical Process**: Captures processes critical to study execution that can relate to _Study Risks_. A list of universal _Critical Processes_ must be defined to create _Study Critical Process_ records. ### Creating Study Risk Assessments {#creating-study-risk-assessments} Create study-specific risk assessments using the risks in your Risk Library, risk assessment templates, and previously created study risk assessments. The new _Study Risk Assessment_ record copies all of the details from the risks, risk categories, and risk mitigations to create new _Study Risk_, _Study Risk Category_, and _Study Risk Mitigation_ records. You can modify the study-specific records as needed to fit the specific needs of your study. Depending on the configuration of your Vault, the _Study Risk Assessment_ may need to go through review and approval lifecycles or workflows. ### The Generate Risk Assessment Action {#generate-risk-assessment-action} The _Generate Risk Assessment_ action lets you apply existing risk assessments and related risk mitigations to your study to create a study-specific risk assessment. To generate a _Study Risk Assessment_: 1. Navigate to the _Study_ record. 2. From the study's **Actions** menu, select **Generate Risk Assessment**. 3. Select the **Risk Assessment Source**. 4. Select a source based on the _Risk Assessment Source_ you selected: * If you selected _Template_, select one or more approved risk assessment templates. Vault condenses any duplicated risks and categories, but does not deduplicate risk mitigations. * If you selected _Existing Study_, select one _Study Risk Assessment_. Vault copies the source field values for _Study Risks_, _Study Risk Categories_, and _Study Risk Mitigations_ unless the **Do not copy this field in Copy Record** is set for the _Object Field_. 5. Click **Generate**. You can run the _Generate Risk Assessment_ action multiple times on the same study. Vault only creates _Study Risks_, _Study Risk Mitigations_, and _Study Risk Categories_ that do not already exist in the _Study Risk Assessment_. ### Managing Study Risk Assessments You can review and update the study-specific risks, risk mitigations, and risk categories, then approve the risks in the _Study Risk Assessment_ record. Navigate to the _Study Risk Assessment_ record to see the details and [scores][12]. Certain fields in the risk-related _Study Risk Categories_, _Study Risks_, and _Study Risk Mitigation_ sections support inline grid editing so that you can make changes without opening individual records. Click **Create** in the _Study Risk Categories,_ _Study Risks_, or _Study Risk Mitigation_ sections to add additional risk categories, risks, or mitigations to the _Study Risk Assessment_ that were not added by the **Generate Risk Assessment** action. When you add new _Study Risks_ to an assessment, Vault automatically creates _Study Risk Mitigation_ records for any risk mitigations related to the _Risk_ you selected. ### Managing Study Risk Mitigations Your mitigations should be specific to the study-specific risk that you are trying to mitigate. For example, if the original _Risk Mitigation_ was for site training, you should update the _Study Risk Mitigation_ to specify what kind of training is needed. While managing your _Study Risk Mitigations_, you can set the _Mitigation Type_ field: * **Action Item**: Vault will automatically generate tasks for users who have the _Role_ in the _Role Responsible_ field on the appropriate _Study_, _Study Country_ or _Study Site_. * **Tracking Only**: Vault will not generate tasks for users. ### Automated Risk Mitigation Actions {#mitigation-actions} When users approve _Study Risk Mitigations_, Vault runs the _Generate Risk Mitigation Actions Per Study_ job based on the following conditions: * The _Mitigation Level_ on the _Study Risk Mitigation_ is _Study_, and the related _Study Risk Assessment_ is in the _Approved_ lifecycle state * The _Mitigation Level_ on the _Study Risk Mitigation_ is _Country_, and a _Study Country_ within that study has a _Country Selected Date_ * The _Mitigation Level_ on the _Study Risk Mitigation_ is _Site_, and a _Site_ within that study has a _Site Selected Date_ The _Generate Risk Mitigation Actions Per Study_ job runs for each _Study_ as users approve _Study Risk Mitigations_. This job creates _Risk Mitigation Action_ _Issues_ (`pdv__ctms`) and starts a workflow if that _Risk Mitigation Action_ has _Risk Action Owners_ assigned. Vault assigns users as _Risk Action Owners_ based on the _Role Responsible_ field on the _Study Risk Mitigation_ and the level of the _Risk Mitigation Action_: * **Study-level**: Users related to the _Person_ selected as _Study Persons_ on the _Study_ with a _Study Team Role_ that matches the _Role Responsible_ of the _Study Risk Mitigation_. * **Country-level**: Users related to the _Person_ selected as _Study Persons_ on the _Study Country_ with a _Study Team Role_ that matches the _Role Responsible_ of the _Study Risk Mitigation_. * **Site-level**: Users related to the _Person_ selected as _Study Persons_ on the _Study Site_ with a _Study Team Role_ that matches the _Role Responsible_ of the _Study Risk Mitigation_. If the _Role Responsible_ field is blank, Vault creates _Risk Mitigation Actions_ but does not assign them to users. You can assign them to the appropriate users at a later date. ### Adding, Modifying & Removing Study Persons When _Study Persons_ are added to, modified or removed from a relevant _Study_, _Study Country_, or _Study Site_, Vault automatically adds or removes the appropriate users as _Risk Action Owners_ on the appropriate unresolved _Risk Mitigation Actions_. If Vault adds a user to a _Risk Mitigation Action_ for the first time, the workflow automatically starts. ### Creating Study Critical Data and Process records If configured, click **Create** in the _Study Critical Data_ and _Study Critical Processes_ sections to define data points and processes critical to study execution. Additionally, critical data points and processes can be related to _Study Risks_. ## Scores {#scores} Vault calculates scores for each _Study Risk_, _Study Risk Category_, and _Study Risk Assessment_. ### Study Risk Scores {#study-risk-scores} Vault calculates the _Risk Score_ based on the values you enter in the _Impact_, _Probability_, and _Detectability_ fields. You can set _Impact_ and _Probability_ as _High_, _Medium_, or _Low_. You can set _Detectability_ as _Difficult_, _Average_, or _Easy_. Vault recalculates the _Risk Score_ when you change the value in the _Impact_, _Probability_, or _Detectability_ fields. Vault applies numeric values to each value to calculate a risk score: * _High_ or _Difficult_ = 3 * _Medium_ or _Average_ = 2 * _Low_ or _Easy_ = 1 Based on the values that you enter for each field, Vault calculates a score for each _Study Risk_ using the formula below: _Risk Score_ = _Impact_ * _Probability_ * _Detectability_ For example, if you set the _Impact_ value to _High_ (3), the _Probability_ value to _Medium_ (2), and the _Detectability_ value to _Average_ (2), the _Risk Score_ is 12: `3 * 2 * 2 = 12` #### Risk Symbols Vault displays a _Risk Symbol_ for each _Study Risk_ based on the study's _Risk Score_. The thresholds that determine which symbol is displayed can be configured by an admin . The symbols are: |Status|Risk Symbol| |--- |--- | |Pending Assessment|Pending Assessment Symbol |Low Risk|Low Risk Score Symbol |Medium Risk|Medium Risk Score Symbol |High Risk|High Risk Score Symbol ### Category Risk Scores {#category-risk-score} Vault calculates the _Category Risk Score_ based on the value you set for _Category Weight_, the scores of the _Study Risks_ in that category, and the total number of _Study Risks_ in that category using the formula below: _Category Risk Score_ = ((Sum of all _Study Risk_ scores in this category) \* _Category Weight_)) / Number of _Study Risks_ in this category For example, if your _Study Risk Assessment_ contains a _Study Risk Category_ with a _Category Weight_ of 0.75 and there are two (2) risks in that category with _Risk Scores_ of 4 and 6, the _Category Risk Score_ is 3.75: `((4 + 6) * 0.75) / 2 = 3.75` ### Overall Risk Score {#overall-risk-score} Vault calculates the _Overall Risk Score_ for the _Study Risk Assessment_ based on the maximum _Study Risk_ score possible (27) and the _Study Risks_ and _Category Weight_ for each _Study Risk Category_. The formula Vault uses to calculate _Overall Risk Score_ for a _Study Risk Assessment_ with two (2) _Study Risk Categories_ is: _Overall Risk Score_ = (((Sum of all _Study Risk_ scores in Category 1) * _Category Weight_ of Category 1) + (Sum of all _Study Risk_ scores in Category 2) * _Category Weight_ of Category 2)) / (((_Category Weight_ of Category 1 * Maximum _Study Risk_ score (27)) * Number of _Study Risks_ in Category 1) + ((_Category Weight_ of Category 2 * Maximum _Study Risk_ score (27)) * Number of _Study Risks_ in Category 2)) For example, if your _Study Risk Assessment_ contains _Study Risk Category_ 1 with a _Category Weight_ of 0.75 and there are two (2) risks in that category with _Risk Scores_ of 4 and 6, and also contains _Study Risk Category_ 2 with a _Category Weight_ of 1.0 and there are two (2) risks in that category with _Risk Scores_ of 12 and 18, then the _Overall Risk Score_ is 39.68%. `(((4+6)*.75)+((12+18)*1))/(((.75*27)*2)+((1*27)*2)) = 39.68%` Vault ignores study risk categories with a _Category Weight_ of zero (0) and study risks with a _Risk Score_ of zero (0) when calculating the _Overall Risk Score_. ## 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 : |Type|Permission Label|Controls| |--- |--- |--- | |Security Profile|Objects: Risk: Create, Edit|Ability to create and edit _Risk_ records.| |Security Profile|Objects: Risk Category: Create, Edit|Ability to create and edit _Risk Category_ records.| |Security Profile|Objects: Risk Template: Create, Edit|Ability to create and edit _Risk Template_ records.| |Security Profile|Objects: Risk Assessment Template: Create, Edit|Ability to create and edit _Risk Assessment Template_ records.| |Security Profile|Objects: Study Risk: Create, Edit|Ability to create and edit _Study Risk_ records.| |Security Profile|Objects: Study Risk Category: Create, Edit|Ability to create and edit _Study Risk Category_ records.| |Security Profile|Objects: Study Risk Assessment: Create, Edit|Ability to create and edit _Study Risk Assessment_ records.| |Security Profile|Objects: Risk Mitigation: Create, Edit|Ability to create and edit _Risk Mitigation_ records.| |Security Profile|Objects: Study Risk Mitigation: Create, Edit|Ability to create and edit _Study Risk Mitigation_ records.| |Security Profile|Objects: Assigned Risk Mitigation: Create, Edit|Ability to create and edit _Assigned Risk Category_ records.| |Security Profile|Objects: Critical Process: Create, Edit|Ability to create and edit _Critical Process_ records.| |Security Profile|Objects: Study Critical Process: Create, Edit|Ability to create and edit _Study Critical Process_ records.| |Security Profile|Objects: Study Critical Data: Create, Edit|Ability to create and edit _Study Critical Data_ records.| |Security Profile|Objects: Study Risk Critical Process: Create, Edit|Ability to create and edit _Study Risk Critical Process_ records.| |Security Profile|Objects: Study Risk Critical Data: Create, Edit|Ability to create and edit _Study Risk Critical Data_ records.| |Security Profile|Tabs: Risk Mitigation Library: View|Ability to view and access the Risk Mitigation Library tab on the navigation bar.| |Security Profile|Tabs: Risk Library: View|Ability to view and access the Risk Library tab on the navigation bar.| |Security Profile|Tabs: Risk Categories: View|Ability to view and access the Risk Categories tab on the navigation bar.| |Security Profile|Tabs: Risk Assessment Templates: View|Ability to view and access the Risk Assessment Templates tab on the navigation bar.| |Security Profile|Tabs: Study Risk Assessments: View|Ability to view and access the Study Risk Assessments tab on the navigation bar.| [3]: #risk-mitigation-library [4]: #study-risk-assessments [7]: #overall-risk-score [8]: #category-risk-score [9]: #study-risk-scores [10]: #generate-risk-assessment-action [11]: #creating-study-risk-assessments [12]: #scores