Create Safety Investigations

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:

You can create Safety Investigations for detected signals. Use Safety Investigations to track, evaluate, and confirm safety issues relevant to the medicinal product. Vault stores Safety Investigations in the Safety Investigations tab.

The sections below describe how to create Safety Investigation records from each signal data source.

Create a Safety Investigation from Statistical Data

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 (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.
  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 record in the Safety Investigations tab.

Create a Safety Investigation from EVDAS eRMR Data

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 record in the Safety Investigations tab.

Create a Safety Investigation from Literature Data

Literature data is maintained in Literature Article records. For instructions on how to create a Safety Investigation from a literature article, see 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 record.
  • The Product Family field is populated.
  • The Investigation Review Outcome field is not set to No Further Action.
  • Creates one (1) Safety Investigation record.
  • 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 Product records.
  • 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 record.
  • 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 Product records.
  • The Product Family fields are populated.
  • For each Product record, the Investigation Review Outcome field is not set to No Further Action and is not left blank.
  • Creates one (1) Safety Investigation record 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.