Manage Risk Management Plans

SafetyDocs supports the management of global and local risk management plans (RMPs). An RMP is a document that defines a marketed product’s safety profile. In the context of Vault:

• A Core Risk Management Plan represents a product’s global, or company-wide, RMP
• A Local Risk Management Plan tailors a Core Risk Management Plan for submission to a specific local agency, such as the FDA or EMA

Overview

This article explains how to:

• Upload RMP documents
• Create a Core Risk Management Plan (RMP)
• Create a Core RMP Version as a working version of an existing Core RMP
• Create Local Risk Management Plans (RMPs) and Local RMP Versions from a Core RMP Version
• Create Local RMP Risks and risk documents from a Local RMP Version
• Copy an existing Core RMP Version to generate a new working version based on an existing Core RMP Version
• Manage related Core RMPs, such as core and EU variants of the same RMP
• Make a Core RMP Version obsolete when it is no longer needed

Prerequisites

To manage RMPs, your Admin must configure your Vault for Risk Management. To manage related Core RMPs, your Admin must enable EU Risk Management Plan Support.

Upload RMP Documents

Upload RMP documents to your Library using one of the following dedicated RMP document types:

• Risk Management > Risk Management Plan > Core RMP
• Risk Management > Risk Management Plan > Local RMP
• Risk Management > Risk Measure > Implementation Plan
• Risk Management > Risk Measure > Local Implementation Plan
• Risk Management > Risk Measure > Measure Outcome
• Risk Management > Risk Measure > Risk Measure Tool

Vault can monitor and detect when a Core RMP document moves into the Approved state and create a series of PVA obligation-related object records to allow you to take the necessary steps to address the related RMP event.

RMP Document Fields

The following fields may be available:

Field	Description
Name	Enter a name for the document. For documents created from a Local RMP Version, Vault populates a name.
Lifecycle	Select the appropriate document lifecycle: General Document Lifecycle: Intended for working documents that, once internally approved, are submitted for health authority feedback and approval. Master Risk Lifecycle: Intended for the master Core RMP document approved for use by a health authority.
Classification	Vault populates the document classification selected during upload. Documents created from a Core RMP Version using the Copy to New Version action inherit a classification.
Core Risk Management Plan	Select the related Core Risk Management Plan (RMP), or select the Advanced Search () icon to use filters and refine your search.
Core RMP Version	Select the related Core RMP Version, or select the Advanced Search icon to use filters and refine your search. Documents created from a Core RMP Version using the Copy to New Version action inherit the initiating Core RMP Version.
Local Risk Management Plan	Select the related Local Risk Management Plan (RMP), or select the Advanced Search icon to use filters and refine your search.
Local RMP Version	Select the related Local RMP Version, or select the Advanced Search icon to use filters and refine your search.
Core Implementation Strategy	Select the related Core Implementation Strategy, or select the Advanced Search icon to use filters and refine your search. When the Copy to New Version action creates a new Core Implementation Strategy, Vault updates this field to refer to the new Core Implementation Strategy.
Local Implementation Strategy	Select the related Local Implementation Strategy, or select the Advanced Search icon to use filters and refine your search.
Market	Select the Country to which this document applies, or select the Advanced Search icon to use filters and refine your search.
Master or Working	Select whether the document is a master or working version: A master document has been approved for use by a health authority. A working document is an in-progress document that, once internally approved, will be submitted to a health authority for approval. For documents created from a Core RMP Version using the Copy to New Version action, Vault populates Master.
Redaction	Select PII Redacted to indicate that Personal Identifiable Information (PII) in the document is masked.
Risk Measure	Select the related Core Risk Measure or Local Risk Measure, or select the Advanced Search icon to use filters and refine your search.

Create a Core Risk Management Plan

To create a Core Risk Management Plan (RMP):

1. Navigate to Risk Management > Core RMPs.
2. Select Create.
3. Complete the applicable fields, then select Save.

Upon successful creation of the Core RMP, the following sections appear:

• Core RMP Versions: Use this section to view existing or create new Core RMP Versions.
• Local RMPs: Once you have created a Core RMP Version, you can create Local RMPs from a Core RMP Version to populate this section.
• Documents: Use this section to view any related RMP documents.

Core Risk Management Plan Fields

The following fields may be available:

Field	Description
Name	Enter a name for the Core Risk Management Plan (RMP). For Core RMPs created via the Create New Core RMP action, Vault populates the name of the sibling Core RMP appended with the opposite Core RMP Type value of the initiating Core RMP.
Product Family	Select the Product Family of the Product that this Core RMP is for. Core RMPs created via the Create New Core RMP action inherit the Product Family from the original sibling Core RMP.
Product	Select the Product for this Core RMP. Core RMPs created via the Create New Core RMP action inherit the Product from the original sibling Core RMP.
Substance	Select the active Substance for this Core RMP. Core RMPs created via the Create New Core RMP action inherit the Substance from the original sibling Core RMP.
Product Launch Date	Enter the date of the first global registration for this Product.
Effective Version	Vault populates this value using the version of the current effective global RMP for this Product. For Core RMPs created via the Create New Core RMP action, Vault leaves this field blank.
Core RMP Type	When managing related Core RMPs for a given Product, select a type from the picklist to define the Core RMP as either company core or EU. For Core RMPs created via the Create New Core RMP action, Vault populates the alternate Core RMP Type value of the original sibling Core RMP.
Covered Countries	When managing related Core RMPs for a given Product, select the Countries for which Vault will create Local RMPs and Local Implementation Strategies.
Based On	When managing related Core RMPs for a given Product, Vault populates the Core RMP from which this Core RMP was created. When managing standalone Core RMPs, leave this field blank. For Core RMPs created via the Create New Core RMP action, Vault populates the original sibling Core RMP.

Create a Core RMP Version

To manually create a Core Risk Management Plan (RMP) Version:

1. Navigate to Risk Management > Core RMPs > [Core RMP].
2. Expand the Core RMP Versions section and select Create.
3. Populate the applicable fields, then select Save.

Upon successful creation of the Core RMP Version, the following sections appear:

• RMP Risks: Use this section to create RMP Risks.
• Risk Measures: Use this section to create Core Risk Measures.
• Documents: Use this section to add any related working documents using the Core RMP document classification.
• Local RMP Versions: This section lists any Local RMP Versions for this Core RMP Version, whether created manually or by Vault.

Core RMP Version Fields

The following fields may be available:

Field	Description
Name	Enter a name. For Core RMP Versions created using the Copy to New Version action or the Create New Core RMP action, Vault populates the Name of the related Core RMP appended with -v and the new Core RMP Version’s Version value. For Core RMP Versions copied from a sibling Core RMP, Vault populates the Name of the parent Core RMP appended with -v and the new Core RMP Version’s Version value.
Core Risk Management Plan	Vault populates the initiating Core RMP. Core RMP Versions created using the Copy to New Version action inherit the initiating Core RMP. For Core RMP Versions copied from a sibling Core RMP, Vault populates the sibling Core RMP. For Core RMP Versions created via the Create New Core RMP action, Vault populates the newly created parent Core RMP.
Product Family	Vault populates the Product Family from the initiating Core RMP.
Product	Vault populates the Product from the initiating Core RMP.
Version	Enter the version number. For Core RMP Versions created using the Copy to New Version action, Vault populates the initiating Core RMP Version’s Version number plus one. For Core RMP Versions copied from a sibling Core RMP, Vault populates the Version of the most recent Core RMP Version on the parent Core RMP plus one. For Core RMP Versions created via the Create New Core RMP action, Vault populates 1.
Based On	When manually creating a Core RMP Version, if applicable, select the Core RMP Version on which this version is based. For the initial version, leave this field blank. Core RMP Versions created using the Copy to New Version action inherit the initiating Core RMP Version. For Core RMPs created using the Create New Core RMP action, Vault populates the initiating Core RMP.
Data Lock Point	Enter the date as of which the safety data is locked for this version by selecting a date on the calendar or entering the date manually. For Core RMP Versions created using the Copy to New Version action, the Create New Core RMP action, or copied from a sibling Core RMP, Vault populates the current date.
Effective Date	Enter the date this version goes into effect by selecting a date on the calendar or entering the date manually.
Rationale for Latest Version	Enter any rationale for creating this version.
Summary of Significant Changes	Enter any information about the changes made for this version.

Create Local RMPs and Local RMP Versions from a Core RMP Version

For each region that requires risk management plans, you can create Local RMPs and Local RMP Versions from a Core RMP Version.

To create Local RMPs and Local RMP Versions from a Core RMP Version:

1. Navigate to Risk Management > Core RMPs > [Core RMP].
2. Expand the Core RMP Versions section and select the Core RMP Version for which you want to create Local RMPs.
3. Change the lifecycle state to Complete.

Once complete, Vault sends a notification and:

• Creates a Local RMP for each qualifying Country and adds it to the Local RMPs section of the related Core RMP Version when:
  • A Local RMP does not yet exist on the related Core RMP
  • The Product Family on the Core RMP is registered on a Product Registration
  • The Country requires an RMP, as determined by the following logic:
    • If the parent Core RMP of the originating Core RMP Version has no Core RMP Type value, Vault considers all Countries with an RMP Required field value of RMP Required
    • If the parent Core RMP of the originating Core RMP Version contains a Core RMP Type value, Vault considers all Countries indicated in its Covered Countries field
• Creates a Local RMP Version for each new Local RMP and adds it to the Local RMP Versions section of the initiating Core RMP Version and the related Local RMP
• Upversions any existing Local RMP Versions on the related Core RMP

Create Local RMP Risks and Documents from a Local RMP Version

To create Local RMP Risks and risk documents from a Local RMP Version:

1. Navigate to Risk Management > Local RMPs > [Local RMP].
2. Expand the Local RMP Versions section and select the Local RMP Version for which you want to create Local RMP Risks and risk documents.
3. Change the lifecycle state to In Progress.

Upon completion, Vault creates the following on the initiating Local RMP Version:

• Local RMP Risks and copies their fields for each:
  • RMP Risk on the related Core RMP Version
  • Local RMP Risk linked only to a previous Local RMP Version, also known as a local-only Local RMP Risk
• Copies the latest version of any working Core RMP-classified documents on the related Core RMP Version and sets the copied document to the Draft state

Copy a Core RMP Version

To create a new Core RMP Version from an existing Core RMP Version:

1. Navigate to Risk Management > Core RMPs > [Core RMP].
2. Expand the Core RMP Versions section and select the Core RMP Version for which you want to create a new version.
3. Select All Actions > Copy to New Version.

Upon completion, Vault sends a notification and makes a copy of:

• The initiating Core RMP Version
• Each RMP Risk on the initiating Core RMP Version
• Each master Core RMP-classified document on the initiating Core RMP Version

Once you have finalized the Core RMP Version, you can create Local RMPs for this Core RMP Version.

Manage Related Core RMPs

To meet both internal and EU-specific requirements, you can create two related (sibling) Core RMPs for a Product. For example, you may have a Core RMP with a Core RMP Type value of EU RMP for managing product requirements in Europe, and a Core RMP with a Core RMP Type value of Company Core RMP for managing your internal company product requirements.

To simplify managing sibling Core RMPs, you can create a new Core RMP from an existing Core RMP Version or copy Core RMP Versions between sibling Core RMPs.

Create a Core RMP From a Core RMP Version

To create a new Core RMP from an existing Core RMP Version:

1. Navigate to Risk Management > Core RMPs > [Core RMP].
2. Expand the Core RMP Versions section and select the Core RMP Version for which you want to create a new Core RMP.
3. Ensure the Core RMP Version is in the Complete lifecycle state and that it contains the required RMP Risks and master Core RMP-classified documents.
4. From the All Actions menu, select Create New Core RMP¹.

After the action finishes running, Vault creates:

• A new Core RMP with the alternate Core RMP Type value of the original sibling Core RMP
• A child Core RMP Version on the new Core RMP based on the initiating Core RMP Version
• A copy of each RMP Risk on the initiating Core RMP Version and links it to the parent Core RMP
• A copy of each master Core RMP-classified document on the initiating Core RMP Version

You can further manage your new Core RMP by adding Covered Countries to define its scope of coverage, then you can create Local RMPs from its Core RMP Versions.

Copy a Core RMP Version to a Sibling Core RMP

If a Core RMP has a sibling, you can copy its Core RMP Version to that sibling as follows:

1. Navigate to Risk Management > Core RMPs > [Core RMP].
2. Expand the Core RMP Versions section and select the Core RMP Version that you want to copy.
3. Ensure the Core RMP Version is in the Complete lifecycle state and that it contains the required RMP Risks and master Core RMP-classified documents.
4. From the All Actions menu, select Copy Version to Core RMP.

After the action finishes running, Vault creates:

• A new Core RMP Version on the sibling Core RMP
• A copy of each RMP Risk on the initiating Core RMP Version, then adds it to the new Core RMP Version and the parent Core RMP
• A copy of each master Core RMP-classified document on the initiating Core RMP Version

Make a Core RMP Version Obsolete

To make a Core RMP Version obsolete:

1. Navigate to Risk Management > Core RMPs > [Core RMP].
2. Expand the Core RMP Versions section and select the Core RMP Version you want to make obsolete.
3. Select All Actions > Make Obsolete.

Create a Local RMP

While Vault can create Local RMPs from a Core RMP Version, you can manually create Local RMPs as required.

To manually create a Local Risk Management Plan (RMP):

1. Navigate to Risk Management > Local RMPs.
2. Select Create.
3. Populate the applicable fields, then select Save.

Upon successful creation of the Local RMP, the following sections appear:

• Local RMP Versions: Use this section to add Local RMP Versions to your Local RMP.
• Documents: Use this section to add any related documents using the Local RMP document classification.

Local RMP Fields

The following fields may be available:

Field	Description
Name	Enter a name. For Local RMPs created from a Core RMP Version, Vault populates the Name of the related Core RMP plus the name of the Market.
Core Risk Management Plan	Select the related Core RMP, or select the Advanced Search () icon to use filters and refine your search. Local RMPs created from a Core RMP Version inherit the Core RMP from the initiating Core RMP Version.
Market	Select the Country to which this local RMP applies, or select the Advanced Search icon to use filters and refine your search. For Local RMPs created from a Core RMP Version, Vault populates the relevant Country.
Substance	Select the Substance related to this local RMP, or select the Advanced Search icon to use filters and refine your search. Local RMPs created from a Core RMP Version inherit the Substance from the initiating Core RMP Version.
Product Family	Select the Product Family related to this local RMP, or select the Advanced Search icon to use filters and refine your search. Local RMPs created from a Core RMP Version inherit the Product Family from the initiating Core RMP Version.
Product	Select the Product related to this local RMP, or select the Advanced Search icon to use filters and refine your search. Local RMPs created from a Core RMP Version inherit the Product from the initiating Core RMP Version.
Local Launch Date	Enter the date the related product was first licensed in this Market. For Local RMPs created from a Core RMP Version, Vault populates the current date.
Effective Version	Enter the version of the current effective Local RMP for the related product.

Create a Local RMP Version

While Vault can create Local RMP Versions from a Core RMP Version, you can manually create Local RMP Versions as required.

To manually create a Local RMP Version:

1. Navigate to Risk Management > Local RMPs > [Local RMP].
2. Expand the Local RMP Versions section and select Create.
3. Populate the applicable fields, then select Save.

Upon successful creation of the Local RMP Version, the following sections appear:

• Local Risks: Use this section to create Local RMP Risks for the Local RMP Version.
• Documents: Use this section to add any related documents using the Local RMP document classification.
• Local Risk Measures: Use this section to create Local Risk Measures for the Local RMP Version.

Local RMP Version Fields

The following fields may be available:

Field	Description
Name	Enter a name. For Local RMP Versions created from a Core RMP Version, Vault populates the Name of the related Core RMP plus the name of the Market, plus the Version number.
Local Risk Management Plan	Vault populates the related Local RMP. For Local RMP Versions created from a Core RMP Version, Vault populates the related Local RMP for the Market.
Core RMP	Vault populates the Core RMP from the related Local RMP.
Core Risk Management Plan Version	Select a Core RMP Version, or select the Advanced Search () icon to select filters and refine your search. Local RMP Versions created from a Core RMP Version inherit the initiating Core RMP Version.
Product Family	Vault populates the Product Family from the initiating Local RMP.
Product	Vault populates the Product from the initiating Local RMP.
Market	Vault populates the Market from the initiating Local RMP.
Version	Enter the version of this local RMP version. For Local RMP Versions created from a Core RMP Version, Vault populates one of the following: If this Market has any existing Local RMP Versions, Vault populates the highest value plus one Otherwise, Vault populates 1.0
Data Lock Point	Enter the date upon which all information in this local RMP version will be valid by selecting a date on the calendar or entering the date manually. For Local RMP Versions created from a Core RMP Version, Vault populates the current date.
Effective Date	Enter the date upon which this local RMP version is approved by selecting a date on the calendar or entering the date manually.
Rationale for Latest Version	Enter any rationale for creating this version. Local RMP Versions created from a Core RMP Version inherit the value from the initiating Core RMP Version.
Summary of Significant Changes	Enter any information about the changes made for this version. Local RMP Versions created from a Core RMP Version inherit the value from the initiating Core RMP Version.