# Create Safety Investigations for Signal Management You can create _Safety Investigations_ for detected _Product-Event Combinations_ (PECs) that require further investigation, or upon request from a health authority. Use _Safety Investigations_ to track, evaluate, and confirm safety issues relevant to the primary medicinal product and across multiple _Products_ and _Product Families_ or _Aggregate Reporting Groups_ that are concomitant or interacting with the _Safety Investigation's_ primary _Product_. Vault stores _Safety Investigations_ in the _Safety Investigations_ tab. As part of the signal management process, you can create a _Safety Investigation_ from:  * [The _Safety Investigations_ tab][1] * [_PEC Periods_][2] * [_Literature Articles_][3] ## Prerequisites {#prerequisites} Before creating _Safety Investigations_, consider the following prerequisites: * To create a _Safety Investigation_ from a _PEC Period_, your Admin must enable Creating Safety Investigations from PEC Periods. * To create a _Safety Investigation_ from a _Literature Article_, your Admin must configure the following: * Creating Safety Investigations from Literature Articles * Literature Review Process Management * Importing Literature References from Databases * Literature Coding to Product Family * Literature Multi-Product Support * Optional: Depending on your business needs, additional features are available for configuration. * To create more detailed _Safety Investigations_, your Admin must enable Capturing Additional Information for Safety Investigations. * To track safety issues related to _Products_ that are concomitant or interacting with the primary _Product_, your Admin must enable Multiple Product Families on Safety Investigations. * To add a _MedDRA Term_ or _MedDRA Query_ directly on a _Safety Investigation_, your Admin must configure Adding MedDRA Terms and Queries for Safety Investigations. * To create _Safety Investigations_ and _Safety Investigation Products_ at the _Aggregate Reporting Group_ level, your Admin must: * Enable Signal Calculations for Product Family Combinations * Configure Signal Calculations Settings for Aggregate Reporting Groups ## Create Safety Investigations from the Safety Investigations Tab {#safety-investigation-from-tab} To create a _Safety Investigation_ from the tab: 1. Navigate to the **Safety Investigations** tab. 2. Select **Create**.  3. Complete the [fields][4]. 4. Select **Save**. Depending on your Admin's configuration, Vault can monitor and detect when a _Safety Investigation_ enters the _Risk Mitigation_ state and create a series of PVA obligation-related object records to allow you to take the necessary steps to address the related signal event. ## About Creating Safety Investigations from PEC Periods {#safety-investigation-from-pec-period} Creating a _Safety Investigation_ from a _PEC Period_ allows you to record details such as the important dates and priority. You can also specify the outcome of your investigation and provide details about relevant data, which is useful for auditing and compliance purposes. To learn more about _PEC Periods_, see Create and Track Product-Event Combinations. You can create a _Safety Investigation_ from: * [A single _PEC Period_][5] * [Multiple _PEC Periods_][6] ### Create a Safety Investigation from a Single PEC Period {#safety-investigation-from-single-pec-period} To create a _Safety Investigation_ from a single _PEC Period_: 1. Navigate to the **PEC Periods** section from one (1) of the following tabs and then select a **PEC Period**:  * **Reporting Periods** * **Product-Event Combinations** 2. From the **All Actions** menu, select **Open Investigation**. \ Vault creates a _Safety Investigation_ and maps the field values from the _PEC Period_.  3. Navigate to the **Safety Investigations** tab and select the new record.  4. Select **Edit**. 5. Complete [fields][4] as needed. 6. Select **Save**. ### Create a Safety Investigation from Multiple PEC Periods {#safety-investigation-from-multiple-pec-periods} To create a _Safety Investigation_ from multiple _PEC Periods_: 1. Navigate to the **Reporting Periods** tab and select a **Reporting Period**. 2. Expand the **PEC Periods** section and select **Show in Tab**. 3. On the _All PEC Periods_ page, from the **All Actions** menu, select **All [n] records** or **Current Page ([n] records)**. You can perform a bulk action for up to 1,000 records. 4. On the _Refine Selection_ page, clear records to refine the list of _PEC Periods_ from which to create the _Safety Investigation_, and then select **Next**. 5. On the _Choose Action_ page, select **Record Actions**, and then select **Next**. 6. On the _Choose Record Action_ page, select **Open Investigation from Dispositions**, and then select **Next**. 7. On the _Confirmation_ page, review the information and then select **Finish**. \ Vault creates a _Safety Investigation_ and maps the field values from the first selected _PEC Period_ record.  8. Navigate to the **Safety Investigations** tab and select the new record.  9. Select **Edit**. 10. Complete [fields][4] as needed. 11. Select **Save**. ## About Creating Safety Investigations from Literature Articles {#safety-investigation-from-literature-article} You can create a _Safety Investigation_ for each _Product Family_ on a _Literature Article_ with an independent _Investigation Review Outcome_ that doesn't result in _No Further Action_. When multiple company _Product Families_ are identified in the article, Vault creates a _Safety Investigation_ and _Literature Data_ record for each _Product Family_ on a _Literature Article_ resulting in an independent _Investigation Review Outcome_ that doesn't result in _No Further Action_. You can also [include multiple _Products_ and _Product Families_][7] in a _Safety Investigation_ to track related products. In a scenario with multiple company _Product Families_ where the _Investigation Review Outcome_ is provided for the primary _Product Family_ only (other _Product Families_ have a blank outcome), Vault creates one (1) _Safety Investigation_ for the primary _Product Family_ and a _Literature Data_ record for each _Product Family_ without the review outcome. For each PEC, identified signals can be linked to a reporting period. ### Create a Safety Investigation from Literature Articles {#create-safety-investigation-from-literature-article} To create a _Safety Investigation_ from a _Literature Article_: 1. Navigate to the **Literature Articles** tab. 2. From the **All Actions** menu next to the related _Literature Article_, select **Open Investigation**. \ Vault creates a _Safety Investigation_ and maps the field values from the _Literature Article_. Vault also creates a _Literature Data_ record linking the _Literature Article_ and the _Safety Investigation_. 3. Navigate to the **Safety Investigations** tab and select the new record.  4. Select **Edit**. 5. Complete [fields][4] as needed. 6. Select **Save**. ## Safety Investigation Fields {#safety-investigation-fields} The following fields may be available:
Field Description
Description

Enter a description for this investigation.

This field supports up to 150 characters.
Product Family

The Product Family being monitored in this investigation.

When you create a Safety Investigation from a PEC Period, Vault maps this value from the PEC Period. Otherwise, select a Product Family from the drop-down or select the Advanced Search (binoculars-icon) icon to use filters and refine your search.

If a Safety Investigation Product does not yet exist, Vault creates one for the Product Family and sets the Rank to 1. In certain scenarios, updating the Safety Investigation Products will update the Product Family at the Safety Investigation level.
Aggregate Reporting Group

The Aggregate Reporting Group being monitored in this investigation.

When you create a Safety Investigation from a PEC Period, Vault maps this value from the PEC Period. Otherwise, select an Aggregate Reporting Group from the drop-down or select the Advanced Search (binoculars-icon) icon to use filters and refine your search.

If a Safety Investigation Product does not yet exist, Vault creates one for the Aggregate Reporting Group and sets the Rank to 1. In certain scenarios, updating the Safety Investigation Products will update the Aggregate Reporting Group at the Safety Investigation level.
Primary Source

The reporting source through which Vault detected the signal for evaluation.

When you create a Safety Investigation from a PEC Period, Vault maps this value from the PEC Period. Otherwise, select a Primary Source from the drop-down or select the Advanced Search icon to use filters and refine your search.
Literature Database

The literature data source through which Vault detected the signal for evaluation.

Select the Advanced Search icon to use filters and refine your search.
Health Authority Database

The health authority data source through which Vault detected the signal for evaluation.

Select a Health Authority Database from the drop-down or select the Advanced Search icon to use filters and refine your search.
Start Date

The date when this investigation was started.

When you create a Safety Investigation from a PEC Period, Vault sets this field to the date of creation. Otherwise, use the calendar to select the date or enter the date manually.
Detection Date

The date when the related PEC was detected for investigation.

Use the calendar to select the date or enter the date manually.

When you create a Safety Investigation from a PEC Period, Vault maps this value from the PEC Period.
Priority Select the priority of the Safety Investigation. The available options include:
  • Critical
  • High
  • Medium
  • Low
Due Date

The date this investigation is due.

Use the calendar to select the date or enter the date manually.
Validation Outcome Select the validation outcome of the Safety Investigation. The available options include:
  • Validated
  • Non-Validated
Validation Outcome Date

The date when the Validation Outcome was set on this investigation.

Vault sets this to the current date whenever the Validation Outcome field is updated.
Validation Outcome Rationale

Enter the reason for this Validation Outcome.

This field supports up to 500 characters.
Final Disposition The final outcome of the Safety investigation. The available options include:
  • Confirmed
  • Refuted
Final Disposition Date

The date when the Final Disposition was set on the Safety Investigation.

Vault sets this to the current date whenever the Final Disposition field is updated.
Disposition Rationale

Enter the reason for this Final Disposition.

This field supports up to 500 characters.
Summary of Key Data

Enter a summary of the data that led to the outcome of this investigation.

This field supports up to 20,000 characters.
### Add Safety Investigation Products to a Safety Investigation {#add-safety-investigation-products} _Safety Investigation Products_ allow you to investigate safety issues across multiple _Products_ and _Product Families_ that may be concomitant or interacting with the primary _Product_ in a single _Safety Investigation_. When you create a _Safety Investigation_ and set the [_Product Family_][8] or [_Aggregate Reporting Group_][12] value, upon saving the record, Vault creates a _Safety Investigation Product_ with a _Rank_ of `1` for this _Product Family_ or _Aggregate Reporting Group_. To add _Safety Investigation Products_ to a _Safety Investigation_: 1. Navigate to the **Safety Investigations** tab and select a **Safety Investigation**. 2. In the _Products_ section, select **Create**. 3. In the _Create Safety Investigation Product_ dialog, complete the following information: * **Product Family**: Select a value from the drop-down or use the **Advanced Search** icon to use filters and refine your search. * **Aggregate Reporting Group**: Select a value from the drop-down or use the **Advanced Search** icon to use filters and refine your search. * **Product**: Select a value from the drop-down or use the **Advanced Search** icon to use filters and refine your search. If a _Product_ is already referenced on the _Product Family_, you can leave this field blank. * **Rank**: Enter the rank number. Only a single rank `1` _Safety Investigation Product_ can exist for the _Safety Investigation_. If you set the rank to _1_ while another already exists, Vault sets the other _Safety Investigation Product_ rank to blank. 4. Select **Save** or **Save + Create** to save the record and create another. **Result** Vault creates a new _Safety Investigation Product_ in the _Products_ section of the _Safety Investigation_. For more information about ranking logic and how the _Product Family_ or _Aggregate Reporting Group_ at the _Safety Investigation_ and _Safety Investigation Product_ levels relate, see the [section below][11]. #### Scenarios {#scenarios} This section describes Vault behavior and ranking logic when you: * Update the [_Product Family_ or _Aggregate Reporting Group_ on the _Safety Investigation_][9] * Update [information on the _Safety Investigation Product_][10] The following table describes Vault behavior when you update the _Product Family_ or _Aggregate Reporting Group_ at the _Safety Investigation_ level:
Scenario Vault Behavior
No Safety Investigation Products exist (due to a new Safety Investigation being created or a user deleting all Safety Investigation Products)
  • Creates a Safety Investigation Product and sets the Product Family or Aggregate Reporting Group to that of the Safety Investigation
  • Sets the Rank to 1 on the Safety Investigation Product
A single Safety Investigation Product exists on the Safety Investigation
  • Updates the Product Family or Aggregate Reporting Group on the Safety Investigation Product to that of the Safety Investigation
  • If the Rank field is blank, sets it to 1
Multiple Safety Investigation Products exist
  • Vault does not update any Safety Investigation Products
When you clear the Product Family or Aggregate Reporting Group value on the Safety Investigation
  • Vault does not update any Safety Investigation Products

The following table describes Vault behavior when you update information, such as the Product Family and Rank, at the Safety Investigation Product level:

Scenario Vault Behavior
When you update the Product Family or Aggregate Reporting Group on the Safety Investigation Product and it is the only one that exists on the Safety Investigation
  • Updates the Product Family or Aggregate Reporting Group at the Safety Investigation level to that of the Safety Investigation Product
When you update the Product Family or Aggregate Reporting Group on a rank 1 Safety Investigation Product
  • Updates the Product Family or Aggregate Reporting Group at the Safety Investigation level to that of the Safety Investigation Product
When you create a new Safety Investigation Product and it is the only one that exists on the Safety Investigation
  • Sets the Rank field to 1, even if you set a different number or leave this field blank
  • Updates the Product Family or Aggregate Reporting Group at the Safety Investigation level to that of the Safety Investigation Product
When you create a rank 1 Safety Investigation Product and multiple Safety Investigation Products already exist
  • If an existing Safety Investigation Product of rank 1 already exists, Vault clears the Rank value of the existing record
  • Updates the Product Family or Aggregate Reporting Group at the Safety Investigation level to that of the Safety Investigation Product
When you update the Rank value on a Safety Investigation Product to 1
  • If an existing Safety Investigation Product of rank 1 already exists, Vault clears the Rank value of the existing record
  • Updates the Product Family or Aggregate Reporting Group at the Safety Investigation level to that of the Safety Investigation Product
When you update the Rank value of a rank 1 Safety Investigation Product to a different number
  • Vault does not update the Product Family or Aggregate Reporting Group at the Safety Investigation level
When you delete a rank 1 Safety Investigation Product
  • Vault does not update the Product Family or Aggregate Reporting Group at the Safety Investigation level
### Add a MedDRA Term or MedDRA Query to a Safety Investigation {#add-meddra-term-or-query} To add either a _MedDRA Term_ or _MedDRA Query_ directly on a _Safety Investigation_: 1. On the _Safety Investigation_, expand the _Events_ section. 2. Select **Create**. 3. In the _Create Safety Investigation Event_ dialog, complete the following information: * **Name**: Enter a **Name** for this _Safety Investigation_ event. * **MedDRA**: Use the drop-down or the **Advanced Search** icon to select a _MedDRA Term_. You can select either a _MedDRA Term_ or a _MedDRA Query_, but not both. * **MedDRA Query**: Use the drop-down or the **Advanced Search** icon to select a _MedDRA Query_. You can select either a _MedDRA Term_ or a _MedDRA Query_, but not both. 4. Select **Save**. [1]: #safety-investigation-from-tab [2]: #safety-investigation-from-pec-period [3]: #safety-investigation-from-literature-article [4]: #safety-investigation-fields [5]: #safety-investigation-from-single-pec-period [6]: #safety-investigation-from-multiple-pec-periods [7]: #add-safety-investigation-products [8]: #product-family-field [9]: #safety-investigation-level [10]: #safety-investigation-product-level [11]: #scenarios [12]: #arg-field