Manage Risk Management Plans

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, which represents a product’s global, or company-wide, RMP
• A Local Risk Management Plan, which 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 Local RMPs from a Core RMP Version
• Create a new Core RMP Version
• Make a Core RMP Version obsolete

Prerequisite

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

Create a Core Risk Management Plan

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

1. Navigate to Risk Management > Core RMPs.
2. Select Create.
3. On the Create Core Risk Management Plan page, complete the relevant fields, then select Save:

Field	Description
Name	Enter a name for the Core Risk Management Plan.
Product Family	Select the Product Family of the Product that this Core Risk Management Plan is for.
Product	Select the Product for this Core Risk Management Plan.
Substance	(Optional) Select the active Substance for this Core Risk Management Plan.
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.

Result

Once you save the Core RMP, the following sections appear:

• Core RMP Versions
• Local RMPs
• Documents

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	(Optional) Enter the final approval date for this Core RMP Version.
Rationale for Latest Version	(Optional) Enter any additional rationale for this Core RMP Version.
Summary of Significant Changes	(Optional) Enter any additional information about the changes made for this Core RMP Version.

Result

Once you save the Core RMP Version, the following sections appear:

• RMP Risks
• Risk Measures
• Documents
• Local RMP Versions

RMP Risks Section

In the RMP Risks section, create a record for each of the identified risks associated with the Product.

Select Create and complete the following fields:

Field	Description
Name	Enter a name for the RMP Risk.
Risk Category	Select which category the RMP Risk belongs in: Identified Risk Potential Risk Missing Information
Risk Sub-Category	Select the sub-category the RMP Risk belongs in: Potential harm from overdose Potential for risks resulting from medication errors Potential for transmission of infectious agents Potential for off-label use Risk common to other members of the pharmacological class Potential pharmacokinetic and pharmacodynamic interactions Pregnant and lactating women Effect on fertility Risks associated with disposal Risks related to the administration procedure Paediatric safety issues
MedDRA	Enter a search term for any level of the MedDRA hierarchy and then select Auto-code or the Advanced Search () icon to search in the MedDRA Browser.
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 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 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 RMP records 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 record you want to create Local RMPs for.
3. Select All Actions > Create Local RMPs.

Result

Vault sends a notification after the Create Local RMPs action finishes running and creates the following records:

• Local RMP (if missing)
• Local RMP Version

Create Local RMP Records

Vault creates a Local RMP record for each Country in which the following criteria apply:

• The Product Family reference on the Core RMP is registered on a Product Registration
• The Country record’s RMP Required field has a value of RMP Required
• A Local RMP record does not yet exist

Vault populates any new Local RMP records as follows:

Field	Value
Name	The name of the Core RMP record plus the name of the Market.
Core Risk Management Plan	The Core RMP record referenced on the Core RMP Version record.
Market	The Country of the Local RMP record.
Substance	Vault maps this value from the Core RMP record.
Product Family	Vault maps this value from the Core RMP record.
Product	Vault maps this value from the Core RMP record.
Market Launch Date	The current date.
Effective Version	Vault leaves this field blank.

Create Local RMP Version Records

Vault creates a Local RMP Version record for each Local RMP record created above that is in any state other than Not Applicable, and populates the record as follows:

Field	Value
Name	The name of the Core RMP record 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 record 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 (1). 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 record data from a Core RMP:

1. Navigate to Risk Management > Local RMPs > [Local RMP].
2. Expand the Local RMP Versions section and select the Local RMP Version you want to create local RMP data for.
3. Select All Actions > Create Local RMP Data from Core.

Result

Vault performs the following actions to create Local RMP record data:

• Create Local RMP Risk Records
• Create New Documents for Local RMP Risk Records

Create Local RMP Risk Records

Vault creates a Local RMP Risk record for each RMP Risk Record on the related Core RMP Version, copying their field values.

Vault copies from the current steady-state Local RMP Version any Local RMP Risk records whose Core Risk field is blank.

Create New Documents for Local RMP Risk Records

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 record
Local RMP Version	The initiating Local RMP Version record

Create a New Core RMP Version

To create a new version of a Core RMP:

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

Result

Vault sends a notification after the Copy to New Version action finishes running and copies the following records:

• Core RMP Version record
• Core Risk records
• Documents

Copy Core RMP Version Record

Vault makes a copy of the Core RMP Version record, 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 record
Data Lock Point	The current date
Version	Previous version number plus one (1)
Based On	The Core RMP Version record 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 Risk Records

Vault makes a copy of all the Core RMP Version’s Risk records 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.

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 record you want to make obsolete.
3. Select All Actions > Make Obsolete.