Learn how to manage global and local risk management plans (RMPs).
About Risk Management Plans
A risk management plan (RMP) is a document that defines a marketed product’s safety profile. SafetyDocs provides two RMP objects:
- 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:
- Create a Core Risk Management Plan (RMP)
- Create a new Core RMP from an existing Core RMP Version
- Create Local RMPs from a Core RMP Version
- Create a new Core RMP Version
- Copy a Core RMP Version from one Core RMP to its sibling Core RMP
- Make a Core RMP Version obsolete
Manage Related Core RMPs
To meet both internal and EU-specific requirements, you can create two separate but related (sibling) Core RMPs for a given 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, Vault includes actions for creating a new Core RMP from an existing Core RMP Version and for copying a Core RMP Version from one Core RMP to its sibling Core RMP.
Prerequisites
To use Risk Management Plans, your Admin must configure your Vault for Risk Management. To manage related Core RMPs, your Admin must enable EU Risk Management Plan Support .
Create a Core Risk Management Plan
To create a Core Risk Management Plan (Core RMP):
- Navigate to Risk Management > Core RMPs.
- Select Create.
- On the Create Core Risk Management Plan page, complete the applicable fields.
- Select Save.
Core Risk Management Plan Fields
The following fields may be available:
| Field | Description |
|---|---|
| Name | Enter a name for the Core Risk Management Plan (RMP). |
| Product Family | Select the Product Family of the Product that this Core RMP is for. |
| Product | Select the Product for this Core RMP. |
| Substance | Select the active Substance for this 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. |
| 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. |
| Covered Countries | When managing related Core RMPs for a given Product, select one or more Countries from the picklist. Vault uses these values to define the Countries for which to 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. |
Once you save the Core RMP, the following sections appear:
Core RMP Versions Section
In the Core RMP Versions section, create a record for the initial version of the Core RMP.
Select Create and complete the following fields:
| Field | Description |
|---|---|
| Name | Enter a name for the Core RMP Version. |
| Version | Enter the version number for this Core RMP Version. |
| Based On | For the initial version, leave this field blank. |
| Data Lock Point | Enter the date for which all information in this Core RMP Version is valid. |
| Effective Date | Enter the final approval date for this Core RMP Version. |
| Rationale for Latest Version | Enter any additional rationale for this Core RMP Version. |
| Summary of Significant Changes | Enter any additional information about the changes made for this Core RMP Version. |
Once you save the Core RMP Version, the following sections appear:
RMP Risks Section
In the RMP Risks section, select Create and complete the following fields for each of the identified risks associated with the Product:
| Field | Description |
|---|---|
| Name | Enter a name for the RMP Risk. |
| Risk Category | Select the RMP Risk category. |
| Risk Sub-Category | Select the RMP Risk subcategory. |
| MedDRA |
Enter a search term for any level of the MedDRA hierarchy and then select Auto-code
or the Advanced Search ( |
| MedDRA Query |
If you did not select a MedDRA term, select the Advanced Search ( ) icon to find a
MedDRA Query.
|
You can enter additional information about the RMP Risk in the following text fields:
- Risk Description
- Risk Seriousness
- Risk Frequency
- Risk-Benefit Impact
Navigate back to the Core RMP Version record using the [Core RMP Version] link at the top of the page.
Documents Section
In the Documents section, add any related documents for the Core RMP Version using the standard document creation process. Use the Risk Management > Risk Management Plan > Core RMP document type.
Navigate back to the Core RMP Version record using the [Core RMP Version] link at the top of the page.
Local RMP Versions Section
This section lists any Local RMP Versions for this Core RMP Version, whether they were created manually, or using the Create Local RMPs action.
Once all the information for the Core RMP Version is complete, navigate back to the parent Core RMP record using the [Core RMP] link at the top of the page.
Local RMPs Section
This section lists the Local RMPs created from the Core RMP.
This list is blank initially. Once you have created a Core RMP and a Core RMP Version, create Local RMPs from a Core RMP.
Documents Section
In the Documents section of the Core RMP Version record, add any related documents for the Core RMP Version using the standard document creation process. Use the Risk Management > Risk Management Plan > Core RMP document type.
Create a New Core RMP From an Existing Core RMP Version
To simplify the process of managing related Core RMPs, Vault provides an action that allows you to create a sibling Core RMP from an existing Core RMP Version.
To create a new Core RMP from an existing Core RMP Version:
- Navigate to Risk Management > Core RMPs > [Core RMP].
- Expand the Core RMP Versions section and select the Core RMP Version for which you want to create a new Core RMP.
- Ensure the Core RMP Version is in the Complete lifecycle state and that it contains the required RMP Risks and documents.
- From the All Actions menu, select Create New Core RMP.
Note: As each Core RMP can be related to only one other Core RMP, the Create New Core RMP action can only be run once per set of sibling Core RMPs. As such, the Create New Core RMP action is not available on complete Core RMP Versions related to a parent Core RMP with an existing sibling Core RMP.
After the action finishes running, Vault creates the following:
Create New Core RMP
Vault creates a new Core RMP and populates its fields as follows:
| Field | Description |
|---|---|
| Name | The name of the sibling Core RMP (the parent Core RMP of the initiating Core RMP Version) appended with the Core RMP Type value of the new Core RMP. |
| Product Family | The Product Family on the original sibling Core RMP. |
| Product | The Product on the original sibling Core RMP. |
| Substance | The Substance on the original sibling Core RMP. |
| Product Launch Date | Vault leaves this field blank. |
| Effective Version | Vault leaves this field blank. |
| Core RMP Type | The alternate Core RMP Type value of the original sibling Core RMP. For example, if the original sibling Core RMP has a Core RMP Type value of EU RMP, Vault sets the Core RMP Type value on the new Core RMP to Company Core RMP. |
| Covered Countries | Vault leaves this field blank. |
| Based On | A link to the original sibling Core RMP. |
Create New Core RMP Version
Vault creates a child Core RMP Version on the new Core RMP based on the initiating Core RMP Version and populates its fields as follows:
| Field | Value |
|---|---|
| Name | The name of the new Core RMP appended with -v and the Version value. |
| Core Risk Management Plan | A link to the parent new Core RMP. |
| Data Lock Point | The current date. |
| Version | Vault populates 1. |
| Based On | Vault leaves this field blank. |
| Effective Date | Vault leaves this field blank. |
| Summary of Significant Changes | Vault leaves this field blank. |
| Rationale for Latest Version | Vault leaves this field blank. |
Create Core Risks and Documents
Vault uses the same logic as the Copy to New Version action to create core RMP Risks and documents on the new Core RMP Version, linking any new RMP Risks to the parent Core RMP.
Create Local RMPs from a Core RMP Version
Vault can create Local RMPs from a Core RMP Version, including all its related documents, for each region that requires risk management plans.
To create Local RMPs from a Core RMP Version:
- Navigate to Risk Management > Core RMPs > [Core RMP].
- Expand the Core RMP Versions section and select the Core RMP Version for which you want to create Local RMPs.
- Change the lifecycle state to Complete.
Vault sends a notification after the Create Local RMPs action finishes running and creates the following records:
Create Local RMPs
Vault creates a Local RMP for each Country in which the following criteria apply:
- A Local RMP does not yet exist
- 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
Vault populates any new Local RMPs as follows:
| Field | Value |
|---|---|
| Name | The name of the Core RMP plus the name of the Market. |
| Core Risk Management Plan | The Core RMP referenced on the Core RMP Version. |
| Market | The Country of the Local RMP. |
| Substance | Vault maps this value from the Core RMP. |
| Product Family | Vault maps this value from the Core RMP. |
| Product | Vault maps this value from the Core RMP. |
| Market Launch Date | The current date. |
| Effective Version | Vault leaves this field blank. |
Create Local RMP Versions
Vault creates a Local RMP Version for each Local RMP created above that is in any state other than Not Applicable, and populates the Local RMP Version as follows:
| Field | Value |
|---|---|
| Name | The name of the Core RMP plus the name of the Market plus the Version. |
| Local Risk Management Plan | The Local RMP for the specific country. |
| Core Risk Management Plan Version | The Core RMP Version upon which this Local RMP Version is based. |
| Version | If there are any previous RMP versions for this market, Vault takes the highest value and adds one. Otherwise, Vault sets the version to 1.0. |
| Data Lock Point | The current date. |
| Approval Date | Vault leaves this field blank. |
| Effective Date | Vault leaves this field blank. |
| Rationale for Latest Version | Vault copies the value from the Core RMP Version on which the action was started. |
| Summary of Significant Changes | Vault copies the value from the Core RMP Version on which the action was started. |
Create Local RMP Data from a Core RMP
To create Local RMP data from a Core RMP:
- Navigate to Risk Management > Local RMPs > [Local RMP].
- Expand the Local RMP Versions section and select the Local RMP Version you want to create local RMP data for.
- Select All Actions > Create Local RMP Data from Core.
Vault performs the following actions to create Local RMP data:
Create Local RMP Risks
Vault creates a Local RMP Risk for each RMP Risk on the related Core RMP Version, copying their field values.
Vault copies from the current steady-state Local RMP Version any Local RMP Risks with a blank Core Risk field.
Create New Documents for Local RMP Risks
Vault creates new documents for the Local RMP Version as follows:
- Copies the latest version of any documents related to the Core RMP Version for documents that meet the following criteria:
- The classification is Risk Management > Risk Management Plan > Core RMP
- The Master or Working field value is Working
- If no document exists, Vault creates a new document with the following settings:
| Field | Value |
|---|---|
| Classification | Risk Management > Risk Management Plan > Local RMP |
| Name | (Local RMP Version.Name)-v(version number)-Working |
| Market | The Country on the Local RMP record |
| Core Risk Management Plan | Vault maps this value from the Core document |
| Core RMP Version | Vault maps this value from the Core document |
| Master or Working | Working |
| Local Risk Management Plan | The Local RMP of the initiating Local RMP Version |
| Local RMP Version | The initiating Local RMP Version |
Create a New Core RMP Version
To create a new version of a Core RMP:
- Navigate to Risk Management > Core RMPs > [Core RMP].
- Expand the Core RMP Versions section and select the Core RMP Version for which you want to create a new version.
- Select All Actions > Copy to New Version.
Vault sends a notification after the Copy to New Version action finishes running and copies the following:
Copy Core RMP Version
Vault makes a copy of the Core RMP Version, setting the fields as follows:
| Field | Value |
|---|---|
| Name | The name of the Core RMP appended with -v and the Version Number |
| Core Risk Management Plan | The Core RMP of the initiating Core RMP Version |
| Data Lock Point | The current date |
| Version | Previous version number plus one (1) |
| Based On | The Core RMP Version that was copied |
| Effective Date | Vault leaves this field blank |
| Summary of Significant Changes | Vault leaves this field blank |
| Rationale for Latest Version | Vault leaves this field blank |
Copy Core Risks
Vault makes a copy of all the Core RMP Version’s RMP Risks and copies all field values.
Copy Documents
Vault makes a copy of any documents whose fields match the following criteria:
- Type: Risk Management
- Subtype: Risk Management Plan
- Classification: Core RMP
- Core RMP Version: Same as the Core RMP Version record being copied
- Master or Working: Master
If multiple documents have the same Core RMP Version, Vault selects the document with the latest document Version field value.
Copy a Core RMP Version From One Core RMP to its Sibling Core RMP
To simplify the process of managing Core RMP Versions that are shared between related Core RMPs, Vault provides an action that allows you to copy an existing Core RMP Version to its sibling Core RMP.
Note: As the Copy Version to Core RMP action is intended for managing sibling Core RMPs, this action is available only on Core RMP Versions related to a parent Core RMP that has a sibling Core RMP.
To copy an existing Core RMP Version to a related Core RMP:
- Navigate to Risk Management > Core RMPs > [Core RMP].
- Expand the Core RMP Versions section and select the Core RMP Version that you want to copy.
- Ensure the Core RMP Version is in the Complete lifecycle state and that it contains the required RMP Risks and documents.
- From the All Actions menu, select Copy Version to Core RMP.
After the action finishes running, Vault creates the following:
Create New Core RMP Version
Vault creates a new Core RMP Version on the sibling Core RMP, and populates its fields as follows:
| Field | Value |
|---|---|
| Name | The name of the parent Core RMP (the sibling Core RMP of the parent Core RMP on the initiating Core RMP Version) appended with -v and the Version value. |
| Core Risk Management Plan | A link to the parent Core RMP. |
| Data Lock Point | The current date. |
| Version | The Version value of the most recent Core RMP Version on the parent Core RMP plus 1. |
| Based On | Vault leaves this field blank. |
| Effective Date | Vault leaves this field blank. |
| Summary of Significant Changes | Vault leaves this field blank. |
| Rationale for Latest Version | Vault leaves this field blank. |
Create Core Risks and Documents
Vault uses the same logic as the Copy to New Version action to create core RMP Risks and documents on the new Core RMP Version, linking any new RMP Risks to the parent Core RMP.
Make a Core RMP Version Obsolete
To make a Core RMP Version obsolete:
- Navigate to Risk Management > Core RMPs > [Core RMP].
- Expand the Core RMP Versions section and select the Core RMP Version record you want to make obsolete.
- Select All Actions > Make Obsolete.