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.
Note: This feature is only available on Clinical Operations CTMS Vaults.
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
- Create and edit risk categories from the Risk Management > Risk Categories tab.
- Click Create > Risk Category to create a new Risk Category or click on a Risk Category to edit an existing record.
- Enter a Category Name for the Risk Category.
- Optional: Enter a Category Weight value less than or equal to “1”.
- Click Save.
How to Create Risks
- Create and edit risks from the Risk Management > Risk Library tab.
- Click Create > Risk to create a new Risk or click on a Risk to edit an existing record.
- Enter the details of the Risk record, including the Short Description, Risk Category, Level, Discussion Points, and Considerations.
- Optional: Add Risk Mitigations.
- 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.
To create a Risk Assessment Template:
- Navigate to Risk Management > Risk Assessment Template > Create > Risk Assessment Template.
- Enter a Name for the template.
- Click Save.
- Click Add to add active Risks from your Risk Library to the template.
- Select the Risks that you want to add to the template.
- Optional: Click on Create to create new Risk records for your Risk Library.
- 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
The Risk Mitigation Library is a repository of Risk Mitigations. Risk Mitigations in Vault 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
- Create and edit risk mitigations from the Risk Management > Risk Mitigation Library tab.
- Click Create > Risk Mitigation to create a new Risk Mitigation or click on a Risk Mitigation to edit an existing record.
- Enter the record details.
- Optional: select a Role Responsible that Vault will assign the mitigation to for the selected Mitigation Level.
- 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
You can track, change, review, and approve study-specific risks by assigning risks to a Study Risk Assessment. Vault calculates an Overall Risk Score for each Study Risk Assessment based on the weighted scores of the Study Risk Categories and Study Risks 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.
- Creating a new Study Risk Assessment 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
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
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:
- Navigate to the Study record.
- From the study’s Actions menu, select Generate Risk Assessment.
- Select the Risk Assessment Source.
- 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.
- 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.
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
When Study Risk Mitigations are approved, Vault determines the appropriate Studies, Study Countries, and Study Sites to include in the Generate Risk Mitigation Actions job based on the following conditions:
- If the Mitigation Level on the Study Risk Mitigation is Study, and the related Study Risk Assessment is in the Approved lifecycle state, Vault will include that Study in the nightly job.
- If the Mitigation Level on the Study Risk Mitigation is Country, and a Study Country within that study has a Country Selected Date, Vault will include that Study Country in the nightly job.
- If the Mitigation Level on the Study Risk Mitigation is Site, and a Site within that study has a Site Selected Date, Vault will include that Study Site in the nightly job.
The Generate Risk Mitigation Actions job runs nightly. 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
Vault calculates scores for each Study Risk, Study Risk Category, and Study Risk Assessment.
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 |  |
| Low Risk |  |
| Medium Risk |  |
| High Risk |  |
Category Risk Scores
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
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
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. |