# Manage Risk Management Plans Safety allows you to manage global and local risk management plans (RMPs). 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: * [Upload RMP documents][30] * [Create a _Core Risk Management Plan (RMP)_][0] * [Manage related _Core RMPs_][18] * [Create a new _Core RMP_ from an existing _Core RMP Version_][21] * [Create _Local RMPs_ from a _Core RMP Version_][1] * [Create a new _Core RMP Version_][2] * [Copy a _Core RMP Version_ from one _Core RMP_ to its sibling _Core RMP_][25] * [Make a _Core RMP Version_ obsolete][3] ## 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. ## Manage Related Core RMPs {#manage-related-core-rmps} To meet both internal and EU-specific requirements, you can create two separate but related (sibling) [_Core RMPs_][0] 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_][21] and for [copying a _Core RMP Version_ from one _Core RMP_ to its sibling _Core RMP_][25]. ## Upload RMP Documents {#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_ Depending on your Admin's configuration, 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. ## Create a Core Risk Management Plan {#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 applicable [fields][28]. 4. Select **Save**. ### Core Risk Management Plan Fields {#core-rmp-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_][4] - [_Local RMPs_][5] - [_Documents_][6] ### 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_][7] - _Risk Measures_ - [_Documents_][8] - [_Local RMP Versions_][9] #### RMP Risks Section {#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 (Binoculars icon) icon to search in the MedDRA Browser.

MedDRA Query If you did not select a MedDRA term, select the Advanced Search (Binoculars icon) 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 {#core-rmp-version-documents-section} In the _Documents_ section, add any related documents for the _Core RMP Version_ using the [_Core RMP_ document classification][30]. 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_][1]. ### Documents Section {#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 [_Core RMP_ document classification][30]. ## Create a New Core RMP From an Existing Core RMP Version {#create-new-core-rmp-from-existing-core-rmp-version} To simplify the process of managing [related _Core RMPs_][18], 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_: 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_][7] and [documents][8]. 4. From the **All Actions** menu, select **Create New Core RMP**.
After the action finishes running, Vault creates the following: * [_Core RMP_][22] * [_Core RMP Version_][23] * [Core _RMP Risks_ and documents][24] ### Create New Core RMP {#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 {#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 {#create-core-risks-documents} Vault uses the same logic as the _Copy to New Version_ action to create [core _RMP Risks_][15] and [documents][16] on the [new _Core RMP Version_][23], linking any new _RMP Risks_ to the [parent _Core RMP_][22]. ## 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_: 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**. Vault sends a notification after the _Create Local RMPs_ action finishes running and creates the following records: - [_Local RMP_ (if missing)][10] - [_Local RMP Version_][11] ### Create Local RMPs {#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_][19] 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][20] 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 {#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_: 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**. Vault performs the following actions to create _Local RMP_ data: - [Create _Local RMP Risks_][12] - [Create new documents for _Local RMP Risks_][13] #### Create Local RMP Risks {#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 {#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 {#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_ for which you want to create a new version. 3. Select **All Actions > Copy to New Version**. Vault sends a notification after the _Copy to New Version_ action finishes running and copies the following: - [_Core RMP Version_][14] - [Core _RMP Risks_][15] - [Documents][16] ### Copy Core RMP Version {#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 {#copy-core-risks} Vault makes a copy of all the _Core RMP Version_'s _RMP Risks_ and copies all field values. ### Copy Documents {#copy-core-rmp-version-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 {#copy-core-rmp-version-to-sibling-core-rmp} To simplify the process of managing _Core RMP Versions_ that are shared between [related _Core RMPs_][18], Vault provides an action that allows you to copy an existing _Core RMP Version_ to its sibling _Core RMP_.
To copy an existing _Core RMP Version_ to a related _Core RMP_: 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_][7] and [documents][8]. 4. From the **All Actions** menu, select **Copy Version to Core RMP**. After the action finishes running, Vault creates the following: * [_Core RMP Version_][26] * [Core _RMP Risks_ and documents][27] ### Create New Core RMP Version {#create-new-core-rmp-version-from-sibling} 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 {#create-core-risks-documents-from-sibling} Vault uses the same logic as the _Copy to New Version_ action to create [core _RMP Risks_][15] and [documents][16] on the [new _Core RMP Version_][26], linking any new _RMP Risks_ to the parent _Core RMP_. ## 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**. [0]: #create-a-core-risk-management-plan [1]: #create-local-rmps-from-a-core-rmp-version [2]: #create-a-new-core-rmp-version [3]: #make-a-core-rmp-version-obsolete [4]: #core-rmp-versions-section [5]: #local-rmps-section [6]: #core-rmp-documents-section [7]: #rmp-risks-section [8]: #core-rmp-version-documents-section [9]: #local-rmp-versions-section [10]: #create-local-rmps [11]: #create-local-rmp-versions [12]: #create-local-rmp-risks [13]: #create-new-documents-for-local-rmp-risks [14]: #copy-core-rmp-version [15]: #copy-core-risks [16]: #copy-core-rmp-version-documents [17]: #crm-fields [18]: #manage-related-core-rmps [19]: #core-rmp-type [20]: #covered-countries [21]: #create-new-core-rmp-from-existing-core-rmp-version [22]: #create-new-core-rmp [23]: #create-new-core-rmp-version [24]: #create-core-risks-documents [25]: #copy-core-rmp-version-to-sibling-core-rmp [26]: #create-new-core-rmp-version-from-sibling [27]: #create-core-risks-documents-from-sibling [28]: #core-rmp-fields [29]: #create-core-rmp-version-results [30]: #upload-rmp-documents