Manage Risk Measures | Veeva Vault Help

Learn how to manage core and local risk measures for your Risk Management Plans.

About Risk Measures

A risk measure is an element of a product’s RMP that identifies a specific risk to be tracked, managed, and measured. Risk measures are created from within an existing Risk Management Plan and are defined as either Core Risk Measures or Local Risk Measures.

Overview

This article explains how to:

Create Core Risk Measures
Create Local Risk Measures

Prerequisite

To use Risk Measures, your Admin must configure your Vault for Risk Management.

Create Core Risk Measures

To create the risk measures for a Core Risk Management Plan Version:

Navigate to Risk Management > Core RMPs > [Core RMP].
In the Core RMP Versions section, select the required Core RMP Version record. This is usually the latest version.
In the RMP Risks section, select the required RMP Risk record.
In the Risk Measures section, create a record for each risk measure associated with the selected RMP Risk record:
1. Select Create and in the Create RMP Risk Measure window, select Core Risk Measure.
2. Complete the Core Risk Measure fields.
3. Select Save.
4. In the Documents section of the Core Risk Measure record, upload any related documents for the Risk Measure using the standard document creation process. Use the Risk Management > Risk Measure > Risk Measure Tool document type.
Repeat steps 3 and 4 to create risk measures for each additional RMP Risk record.

Core Risk Measure Fields

Field	Description
Name	Vault populates this field automatically.
Minimized Risk	Select the RMP Risk for the Core Risk Measure.
Indication	Select the MedDRA term for the indication.
Routine/Additional	Select whether the Core Risk Measure is Routine or Additional.
Measure Category	Select the type of risk minimization measure. The options available depend on the selection you made for the Routine/Additional field. The following options are available for routine Core Risk Measures: Summary of Product Characteristics Labeling Package Leaflet Pack Size Legal Status of Product The following options are available for additional Core Risk Measures: Educational Materials Direct Healthcare Professional Communications Pregnancy Prevention Programmes Controlled Access Programmes
Measure Sub-Category	If you defined this Core Risk Measure as Additional, select the appropriate sub-category. If you selected the Educational Materials category, the following options are available: Guides for patients or healthcare professionals for risk minimization Healthcare professional checklists for risk minimisation Risk awareness forms Demonstration kits Patient diaries for risk minimisation Patient cards If you selected the Controlled Access Programmes category, the following options are available: Controlled prescription and supply system Center accreditation systems Forms for patient information exchange between prescriber and dispenser Dispensing forms Note: If you selected Direct Healthcare Professional Communications or Pregnancy Prevention Programmes, no sub-categories are available.
Core Implementation Strategy	Select the Core Implementation Strategy for the Core Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search. If the drop-down is blank, you must first create a Core Implementation Strategy.
Version	Enter the applicable version number for the Core Risk Measure.
Based On	If applicable, select the Risk Measure record on which this Core Risk Measure record is based.
Planned Start Date	Enter the Risk Measure's expected start date. Use the calendar to select the date or enter the date manually.
Actual Start Date	Enter the actual date the Risk Measure came into force. Use the calendar to select the date or enter the date manually.
Actual End Date	Enter the actual date the Risk Measure ended. Use the calendar to select the date or enter the date manually.

Create Local Risk Measures

When the Create Local RMPs action creates Local Risk Management Plan Version records, these records inherit a copy of the Risk Measure records from their parent Core Risk Management Plan Version.

If required, complete the following steps to create additional Local Risk Measure records for a Local Risk Management Plan Version:

Navigate to Risk Management > Local RMPs > [Local RMP].
In the Local RMP Versions section, select the required Local RMP Version record. This is usually the latest version.
In the Local Risks section, select the required Local RMP Risk record.
In the Risk Measures section, create a record for each risk measure associated with the selected Local RMP Risk record:
1. Select Create and in the Create RMP Risk Measure window, select Local Risk Measure.
2. Complete the Local Risk Measure fields.
3. Select Save.
4. In the Documents section of the Local Risk Measure record, upload any related documents for the Risk Measure using the standard document creation process. Use the Risk Management > Risk Measure > Risk Measure Tool document type.
5. In the Risk Measure Tracking section, select Create and complete the RMP Risk Measure Tracking fields.
6. Select Save.
7. Navigate back to the Local Risk Measure record using the [Local Risk Measure] link at the top of the page.
Repeat steps 3 and 4 to create Local Risk Measure records for each additional RMP Risk record.

Local Risk Measure Fields

Field	Description
Name	Vault populates this field automatically.
Minimized Risk	To populate this field, you must first populate the RMP and RMP Version fields. Select the Minimized Risk value for the Local Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Minimized Local Risk	If Vault does not populate this field automatically, you may select the specific risk that this measure will help to minimize in the local market from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Indication	Select the MedDRA term for the indication.
Routine/Additional	Select whether the Local Risk Measure is Routine or Additional.
Measure Category	Select the type of risk minimization measure. The options available depend on the selection you made for the Routine/Additional field. The following options are available for routine Local Risk Measures: Summary of Product Characteristics Labeling Package Leaflet Pack Size Legal Status of Product The following options are available for additional Local Risk Measures: Educational Materials Direct Healthcare Professional Communications Pregnancy Prevention Programmes Controlled Access Programmes
Measure Sub-Category	If you defined this Local Risk Measure as Additional, select the appropriate sub-category. If you selected the Educational Materials category, the following options are available: Guides for patients or healthcare professionals for risk minimization Healthcare professional checklists for risk minimisation Risk awareness forms Demonstration kits Patient diaries for risk minimisation Patient cards If you selected the Controlled Access Programmes category, the following options are available: Controlled prescription and supply system Center accreditation systems Forms for patient information exchange between prescriber and dispenser Dispensing forms Note: If you selected Direct Healthcare Professional Communications or Pregnancy Prevention Programmes, no sub-categories are available.
Core Risk Measure	Select the Core Risk Measure on which this Local Risk Measure is based from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Market	Select the Country to which this Local Risk Measure applies from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Local Disposition	Select how the Local 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 Risk Measure record on which this Local Risk Measure record is based from the drop-down or select the Advanced Search () icon to use filters and refine your search.
RMP	Select the RMP for the Core Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search.
RMP Version	Select the RMP Version for the Core Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Local RMP	Vault populates this field automatically.
Local RMP Version	Vault populates this field automatically.
Core Implementation Strategy	Select the Core Implementation Strategy for the Core Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search. If the drop-down is blank, you must first create a Core Implementation Strategy.
Local Implementation Strategy	Select the Local Implementation Strategy that covers the development of this minimization tool from the drop-down or select the Advanced Search () icon to use filters and refine your search.
HA Submission Date	Enter the date the Risk Measure was submitted to the health authority for endorsement. Use the calendar to select the date or enter the date manually.
HA Endorsement Date	Enter the date the Risk Measure was endorsed by the health authority for use. Use the calendar to select the date or enter the date manually.
Planned Start Date	Enter the Risk Measure's expected start date. Use the calendar to select the date or enter the date manually.
Actual Start Date	Enter the actual date the Risk Measure started. Use the calendar to select the date or enter the date manually.
Actual End Date	Enter the actual date the Risk Measure ended. Use the calendar to select the date or enter the date manually.

RMP Risk Measure Tracking Fields

Field	Description
Target Date	Enter the target date for distribution of the Risk Measure. Use the calendar to select the date or enter the date manually.
Target Completion Date	Enter the expected tracking period end date for the Risk Measure. Use the calendar to select the date or enter the date manually.
Target Value	Enter the target numeric outcome of the Risk Measure.
Outcome Verdict	Select the evaluation of the actual outcome of the Risk Measure: Target Met Target Missed Target Cancelled
Channel	Enter the distribution channel for the Risk Measure.
Actual Date	Enter the date that the outcome of the Risk Measure was recorded. Use the calendar to select the date or enter the date manually.
Actual Completion Date	Enter the date that the tracking period of the Risk Measure ended. Use the calendar to select the date or enter the date manually.
Actual Value	Enter the actual outcome of the Risk Measure.