# Create Safety Investigations for Signal Data Sources Learn how to create _Safety Investigations_ for each data source. ## About Safety Investigations Safety Signal can detect _Product-Event Combination_ (PEC) signals that require further analysis from the following data sources: * [PV][1] * [EVDAS][2] * [Literature][3] You can create _Safety Investigations_ for detected signals. Use _Safety Investigations_ to track, evaluate, and confirm safety issues relevant to the medicinal product and across multiple _Products_ and _Product Families_ that are concomitant or interacting with the _Safety Investigation's_ primary _Product_. Vault stores _Safety Investigations_ in the _Safety Investigations_ tab. The sections below describe how to create _Safety Investigations_ from each signal data source. ## Create a Safety Investigation from Statistical Data {#safety-investigation-pv} Pharmacovigilance (PV) signal data is maintained in _Statistical Data_ records. ### Start the Workflow for a Safety Investigation To start the workflow for a _Safety Investigation_: 1. Navigate to the **Statistical Data** tab and select the relevant record. 2. From the **Workflow and State Change** (workflow-state-chang) icon, select the applicable change state action. 3. On the confirmation dialog, select **Yes**. ### Create a Safety Investigation from a Statistical Data Record There are two (2) ways to create a _Safety Investigation_ from a _Statistical Data_ record. To create a _Safety Investigation_ from the _Safety Investigation_ field on a _Statistical Data_ record: 1. Navigate to the **Statistical Data** tab and select a record. 2. Select the **Edit** (edit-icon) icon. 3. In the _Safety Investigation_ field, do one of the following: * To select an existing _Safety Investigation_, select the drop-down or the **Advanced Search** icon to use filters and refine your search. * To create a new _Safety Investigation_, select **Create Safety Investigation**. 4. If creating a new _Safety Investigation_, in the _Create Safety Investigation_ dialog, populate the fields as needed and then select **Save**. 5. Select **Save**. To create a _Safety Investigation_ using the _Open Investigation_ action: 1. Navigate to the **Statistical Data** tab. 2. Beside a _Statistical Data_ record, select the **Actions** menu. 3. Select **Open Investigation**. **Results** Vault creates the _Safety Investigation_ in the _Safety Investigations_ tab. ## Create a Safety Investigation from EVDAS eRMR Data {#safety-investigation-evdas} EudraVigilance Data Analysis System (EVDAS) signal data is maintained in _EVDAS eRMR_ records. ### Start the Workflow for a Safety Investigation To start the workflow for a _Safety Investigation_: 1. Navigate to the **EVDAS eRMR** tab and select the relevant record. 2. From the **Workflow and State Change** (workflow-state-chang) icon, select the applicable change state action. 3. On the confirmation dialog, select **Yes**. ### Create a Safety Investigation from an EVDAS eRMR Record To create a _Safety Investigation_ from an _EVDAS eRMR_ record: 1. Navigate to the **EVDAS eRMR** tab and select a record. 2. In the _Safety Investigation_ field, do one (1) of the following: * To select an existing _Safety Investigation_, select the drop-down or the **Advanced Search** icon to use filters and refine your search. * To create a new _Safety Investigation_, select **Create Safety Investigation**. 3. If creating a new _Safety Investigation_, in the _Create Safety Investigation_ dialog, populate the fields as needed and then select **Save**. 4. Select **Save**. **Results** Vault creates the _Safety Investigation_ in the _Safety Investigations_ tab. ## Create a Safety Investigation from Literature Data {#safety-investigation-literature} Literature data is maintained in _Literature Articles_. For instructions on how to create a _Safety Investigation_ from a literature article, see Create Safety Investigations for Signal Management. ### Scenarios When you create a _Safety Investigation_ from a _Literature Article_, the following scenarios may occur:
Scenario Criteria Vault Behavior
One (1) Product results in one (1) Safety Investigation
  • There is one (1) Literature Article Product.
  • The Product Family field is populated.
  • The Investigation Review Outcome field is not set to No Further Action.
  • Creates one (1) Safety Investigation.
  • Creates one (1) Literature Data record.
  • Links the related Safety Investigation and Literature Data records together.
Multiple Products result in one (1) Safety Investigation
  • There are two (2) or more Products.
  • For the rank 1 Product:
    • The Product Family is populated.
    • The Investigation Review Outcome field is not set to No Further Action.
  • For other Products:
    • The Investigation Review Outcome field is left blank.
  • Creates one (1) Safety Investigation.
  • Creates one (1) Literature Data record for each unique Product Family.
  • Links the related Safety Investigation and Literature Data records together.
Multiple Products result in multiple Safety Investigations
  • There are two (2) or more Products.
  • The Product Family fields are populated.
  • For each Product, the Investigation Review Outcome field is not set to No Further Action and is not left blank.
  • Creates one (1) Safety Investigation for each unique Product Family.
  • Creates one (1) Literature Data record for each unique Product Family.
  • Links the related Safety Investigation and Literature Data records together.
[1]: #safety-investigation-pv [2]: #safety-investigation-evdas [3]: #safety-investigation-literature