Manage Risk Measures | Veeva Vault Help

A risk measure is an element of a product’s RMP that identifies a specific risk to be tracked, managed, and measured. In the context of Vault, each risk measure is related to an existing Core RMP Version, Local RMP Version, Core Implementation Strategy, or Local Implementation Strategy.

Overview

This article explains how to:

Create RMP Risks to capture risks associated with a Core RMP Version
Create Core Risk Measures to define the risk tracking plan for an RMP Risk
Create Local RMP Risks to capture risks associated with a Local RMP Version
Create Local Risk Measures to define the risk tracking plan for a Local RMP Risk
Create Risk Measure Tracking records to capture risk measure distribution and tracking data for Local Risk Measures

Prerequisite

To manage risk measures, your Admin must configure your Vault for Risk Management.

Create an RMP Risk

To create an RMP Risk for a Core RMP Version:

Navigate to Risk Management > Core RMPs > [Core RMP].
Expand the Core RMP Versions section and select the relevant Core RMP Version.
From the Core RMP Version, expand the RMP Risks section and select Create.
In the Create RMP Risk window, populate the applicable fields, then select Save.

Upon successful creation of the RMP Risk, you can expand the Risk Measures section to define its Core Risk Measures as needed. We recommend creating a Core Risk Measure for each RMP Risk associated with a Core RMP Version.

RMP Risk Fields

The following fields may be available:

Field	Description
Name	Enter a name to identify the risk.
RMP Version	Vault populates the initiating Core RMP Version.
Risk Category	Select the risk category.
Risk Sub-Category	Select the risk sub-category.
MedDRA	Enter a term and select Auto-code to auto-code the relevant MedDRA term, or select the Advanced Search () icon to open the MedDRA Browser and refine your search.
MedDRA Query	If you did not select a MedDRA term, select a MedDRA Query or select the Advanced Search icon to use filters and refine your search.
Risk Description	Enter any relevant details to describe the risk.
Risk Seriousness	Enter any relevant details to define the risk seriousness.
Risk Frequency	Enter any relevant details to define the risk frequency.
Risk-Benefit Impact	Enter relevant details to define the risk-benefit impact.

Create a Core Risk Measure

To create a Core Risk Measure:

Navigate to Risk Management > Core Risk Measures.
Select Create.
Populate the applicable fields, then select Save.

Upon successful creation of the Core Risk Measure, the following sections appear:

Documents: Use this section to add any related documents using the Risk Measure Tool document classification.
Local Risk Measures: Use this section to create Local Risk Measures for the Core Risk Measure.

Core Risk Measure Fields

Field	Description
Name	Vault populates using the following format: `{measure_category__v} - {measure_sub_category__v} - v{version__v} {market__vr.abbreviation_2__v} - {#}`.
RMP	Select the Core Risk Management Plan (RMP) related to the risk measure, or select the Advanced Search () icon to use filters and refine your search. Core Risk Measures created from an RMP Risk inherit the Core RMP related to the initiating RMP Risk.
RMP Version	Select the Core RMP Version related to the risk measure, or select the Advanced Search icon to use filters and refine your search. Core Risk Measures created from an RMP Risk inherit the Core RMP Version from the initiating RMP Risk.
Minimized Risk	Select the RMP Risk related to the risk measure, or select the Advanced Search icon to use filters and refine your search. Core Risk Measures created from an RMP Risk inherit the initiating RMP Risk.
Indication	Enter the MedDRA term for the indication and select Auto-code to auto-code the relevant MedDRA term, or select the Advanced Search icon to open the MedDRA Browser and refine your search.
Routine/Additional	Select whether the risk measure is routine or additional.
Measure Category	Select the type of risk minimization measure. Available options depend on your Routine/Additional selection.
Measure Sub-Category	For additional risk measures, select a sub-category. Available options depend on your Measure Category selection.
Core Implementation Strategy	Select the Core Implementation Strategy related to this risk measure, or select the Advanced Search icon to use filters and refine your search.
Version	Enter the applicable version number.
Based On	If applicable, select the Core Risk Measure or Local Risk Measure on which this risk measure is based, or select the Advanced Search icon to use filters and refine your search. For the initial version, leave this field blank.
Planned Start Date	Enter the expected start date for the risk measure by selecting a date on the calendar or entering the date manually.
Actual Start Date	Enter the actual date the risk measure came into force by selecting a date on the calendar or entering the date manually.
Actual End Date	Enter the actual date the risk measure ended by selecting a date on the calendar or entering the date manually.

Create a Local RMP Risk

When a Local RMP Version moves to the In Progress state, Vault uses the data from the Local RMP Version and its related Core RMP Version to create Local RMP Risks. If needed, you can also manually create Local RMP Risks.

To manually create a Local RMP Risk for a Local RMP Version:

Navigate to Risk Management > Local RMPs > [Local RMP].
Expand the Local RMP Versions section and select the relevant Local RMP Version.
From the Local RMP Version, expand the Local Risks section and select Create.
In the Create Local RMP Risk window, populate the applicable fields, then select Save.

Upon successful creation of the Local RMP Risk, you can expand the Risk Measures section to define its Local Risk Measures as needed.

Local RMP Risk Fields

The following fields may be available:

Field	Description
Name	Enter a name to identify the risk.
Local RMP Version	Vault populates the initiating Local RMP Version.
Risk Category	Select the risk category.
Risk Sub-Category	Select the risk sub-category.
MedDRA	Enter a term and select Auto-code to auto-code the relevant MedDRA term, or select the Advanced Search () icon to open the MedDRA Browser and refine your search.
MedDRA Query	If you did not select a MedDRA term, select a MedDRA Query, or select the Advanced Search icon to use filters and refine your search.
Risk Description	Enter any relevant details to describe the risk.
Risk Seriousness	Enter any relevant details to define the risk seriousness.
Risk Frequency	Enter any relevant details to define the risk frequency.
Risk-Benefit Impact	Enter relevant details to define the risk-benefit impact.

Create a Local Risk Measure

When the related Core RMP Version moves to the Complete state, Vault uses the data from the Core RMP and Core RMP Version to create Local RMPs and Local RMP Versions for the relevant countries. You can add Local Risk Measures to each Local RMP Version as needed.

Note: We recommend creating a Local Risk Measure for each Local RMP Risk associated with the Local RMP Version.

To create a Local Risk Measure:

Navigate to Risk Management > Local Risk Measures.
Select Create.
Populate the applicable fields, then select Save.

Upon successful creation of the Local Risk Measure, the following sections appear:

Documents: Use this section to add any related documents using the Risk Measure Tool document classification.
Risk Measure Tracking: Use this section to create RMP Risk Measure Tracking records.

Local Risk Measure Fields

The following fields may be available:

Field	Description
Name	Vault populates a name using the following format: `{measure_category__v} - {measure_sub_category__v} - v{version__v} {market__vr.abbreviation_2__v} - {#}`. For Local Risk Measures created from a Core Implementation Strategy, Vault populates the name of the related Core Risk Measure plus the Market.
Minimized Risk	Select the RMP Risk that this measure is intended to minimize or select the Advanced Search () icon to use filters and refine your search.
Minimized Local Risk	Select the Local RMP Risk that this measure will help to minimize in the local market or select the Advanced Search icon to use filters and refine your search.
Indication	Enter the MedDRA term for the indication and select Auto-code to auto-code the relevant MedDRA term, or select the Advanced Search icon to open the MedDRA Browser and refine your search.
Routine/Additional	Select whether the risk measure is routine or additional.
Measure Category	Select the type of risk minimization measure. Available options depend on your Routine/Additional selection.
Measure Sub-Category	If you defined this risk measure as Additional, select the appropriate sub-category. Available options depend on your Measure Category selection.
Core Risk Measure	Select the Core Risk Measure on which this risk measure is based or select the Advanced Search icon to use filters and refine your search. Local Risk Measures created from a Core Implementation Strategy inherit the related Core Risk Measure.
Market	Select the Country to which this risk measure applies or select the Advanced Search icon to use filters and refine your search. Local Risk Measures created from a Core Implementation Strategy inherit the Market from the related Local Implementation Strategy.
Local Disposition	Select how this risk measure will be used in the applicable region: Core As Is: Use the Local Risk Measure in the same way as the Core Risk Measure. Core Modified: Use the Local Risk Measure in the same way as the Core Risk Measure, but with some modifications. Country Specific: Use the Local Risk Measure in a way that is specific to the applicable Country. Not Applicable: The Local Risk Measure is not applicable to this region.
Version	Enter the applicable version number for the Local Risk Measure.
Based On	If applicable, select the Core Risk Measure or Local Risk Measure on which this risk measure is based or select the Advanced Search icon to use filters and refine your search. For the initial version, leave this field blank.
RMP	Select the related Core RMP or select the Advanced Search icon to use filters and refine your search.
RMP Version	Select the related Core RMP Version or select the Advanced Search icon to use filters and refine your search.
Local RMP	Select the related Local RMP or select the Advanced Search icon to use filters and refine your search. Local Risk Measures created from a Core RMP Version inherit the related Local RMP.
Local RMP Version	Select the related Local RMP Version or select the Advanced Search icon to use filters and refine your search. Local Risk Measures created from a Core RMP Version inherit the related Local RMP Version.
Core Implementation Strategy	Select the related Core Implementation Strategy or select the Advanced Search icon to use filters and refine your search. Local Risk Measures created from a Core Implementation Strategy inherit the initiating Core Implementation Strategy.
Local Implementation Strategy	Select the related Local Implementation Strategy that covers the development of the risk measure for this market or select the Advanced Search icon to use filters and refine your search. Local Risk Measures created from a Core Implementation Strategy inherit the related Local Implementation Strategy for the Market.
HA Submission Date	Enter the date the risk measure was submitted to the health authority for endorsement by selecting a date on the calendar or entering the date manually.
HA Endorsement Date	Enter the date the risk measure was endorsed by the health authority for use by selecting a date on the calendar or entering the date manually.
Planned Start Date	Enter the expected start date for the risk measure by selecting a date on the calendar or entering the date manually.
Actual Start Date	Enter the actual date the risk measure started by selecting a date on the calendar or entering the date manually.
Actual End Date	Enter the actual date the risk measure ended by selecting a date on the calendar or entering the date manually.

Create RMP Risk Measure Tracking Records

To create an RMP Risk Measure Tracking record for a Local Risk Measure:

Navigate to Risk Management > Local Risk Measures > [Local Risk Measure].
Expand the Risk Measure Tracking section, then select Create.
Populate the applicable fields, then select Save.

RMP Risk Measure Tracking Fields

The following fields may be available:

Field	Description
Risk Measure	Vault populates the initiating Local Risk Measure.
Target Date	Enter the target date for distribution of the Local Risk Measure by selecting a date on the calendar or entering the date manually.
Target Completion Date	Enter the expected tracking period end date for the Local Risk Measure by selecting a date on the calendar or entering the date manually.
Target Value	Enter the target distribution outcome for the Local Risk Measure.
Outcome Verdict	Select the evaluation of the actual outcome for the Local Risk Measure.
Channel	Enter the distribution channel for the Local Risk Measure.
Actual Date	Enter the date that the outcome of the Local Risk Measure was recorded by selecting a date on the calendar or entering the date manually.
Actual Completion Date	Enter the date that the tracking period of the Local Risk Measure ended by selecting a date on the calendar or entering the date manually.
Actual Value	Enter the actual outcome of the Local Risk Measure.