**Source URL:** https://safety.veevavault.help/en/lr/1117909/index.md

# Perform Safety Case Investigations

Safety Case Investigation provides a standardized approach to monitoring issues with _Cases_. Leveraging Vault <a href="/en/lr/39659/">report types</a> and <a href="/en/lr/8934/">dashboards</a>, you can initiate investigations into such areas as late cases, duplicate cases, and health authority inquiries. Working within Vault to manage these investigations avoids the need to use manual external tools and trackers, improving accuracy and time-to-issue resolution. Safe Case Investigations represent only the Safety side of an investigation, and may be used in conjunction with your other processes.

Safety Case Investigations support [Late Case Investigations][1].

## Standard Report Types

Vault includes the following standard report types for Safety Case Investigations, which you can <a href="/en/lr/3606/">modify</a> to meet your business needs:

* _Safety Case Investigation_
* _Safety Case Investigation with Reference and Transmission_
* _Transmission with Case and Safety Case Investigation_
* _Safety Case Investigation Reference with SCI and Action_
* _Safety Case Investigation with Case Version_
* _Safety Case Investigation with Transmission_

## Late Case Investigations {#late-case}

Use _Late Case Investigations_ to capture details about late _Cases_, such as the cause of the delay, the number of impacted transmissions, the due date and outcomes of the investigation, and a list of involved parties. You can associate a late _Case_ or _Transmission_ with multiple _Late Case Investigations_. Based on your Admin's configuration, you can attach relevant documents, link to your organization's Quality findings, and require reviewer signatures. You can <a href="/en/lr/44069/#download-as-pdf">download</a> _Late Case Investigations_ as a PDF.

Standard _Late Case Investigations_ use the following lifecycle states:

* _New_
* _Active_
* _Investigation Required_
* _Investigation_
* _Analysis Required_
* _Analysis_
* _Documentation Required_
* _Documentation_
* _Review Required_
* _Review_
* _Complete_
* _Inactive_

### Late Case Investigation Fields

_Late Case Investigations_ may include the following pages, sections, and fields.

#### Identification Page

Use the _Identification_ page to add details and a description about the _Late Case Investigation_. The following sections and fields may be available:

* **Due Date**: Enter the due date for the investigation. Use the calendar to select the date or enter the date manually.
* **Reason**: Select the reason for the investigation.
* **Description**: Enter a description of the issues that caused the investigation.

#### Investigation Page {#investigation-page}

Use the _Investigation_ page to add a summary about the investigation, as well as to add or review impacted _Case Versions_, _Transmissions_, and _Responsible Organizations_. The following sections and fields may be available:

* **Summary**: Enter relevant investigation details such as the extent of the impact and a statement about the root cause.
* **Impacted Case Versions**: Add _Case Versions_ impacted by the issue under investigation. On each record, you can capture information about the delay.
    * If the information exists on the <a href="/en/lr/01287/#potential-late-reason">_Case_</a>, Vault maps the details to the _Impacted Case Version_ record. 
    * If you populate the following fields, Vault maps the value to the _Case_ field, overwriting any existing values:
        * **Potential Late Reason**: Select the potential reason that _Case_ processing may be delayed.
        * **Potential Late Reason Details**: Enter details about the potential reason that _Case_ processing may be delayed.
* **Impacted Transmissions**: Add _Transmissions_ impacted by the issue under investigation. On each record, you can capture information about the delay.
    * If the information exists on the <a href="/en/lr/1022564/#late-review">_Transmission_</a>, Vault maps the details to the _Impacted Transmissions_ record.
    * If you populate the following fields, Vault maps the value to the _Transmission_ fields, overwriting any existing values:
        * **Late Assessment**: Select an assessment of whether the _Transmission_ was late.
        * **Late Assessment Details**: Enter details to describe the _Late Assessment_. 
        * **Late Reason**: Select the reason the _Transmission_ was late.
        * **Late Status**: Select the status of the _Transmission_.
* **Responsible Organizations**: Add the _Organizations_ related to the issue under investigation.

#### Analysis Page

Use the _Analysis_ page to add an impact assessment, recommendations, and a conclusion. The following sections and fields may be available:

* **Issue Impact**: Select the severity of the impact the issue caused.
* **Impacted Areas**: Select the areas that were impacted by the issue.
* **Impacted Case Versions**: Vault populates the number of _Case Versions_ impacted by the issue.
* **Impacted Transmissions**: Vault populates the number of _Transmissions_ impacted by the issue.
* **Recommendations**: Enter any recommendations that came out of the investigation findings and analysis.
* **Final Conclusion**: When the investigation can be closed, enter any concluding comments.

#### Activities Page

Use the _Activities_ page to assign and complete [action items][2] and review the workflow timeline of the investigation.

#### References Page

Use the _References_ page to add external references, attachments, and documents related to the investigation. The following sections and fields may be available:

* **External References**: Add references to link the _Late Case Investigation_ to external systems, such as the ticket number from your Quality Management System.
* **Type**: Select the type of reference.
* **URL**: Enter the URL of the external system.
* **Attachments**: Add <a href="/en/lr/58613/#adding-attachments">attachments</a>.
* **Documents**: Add <a href="/en/lr/18769/#related-documents">documents</a> with the _Case > Investigations > Late Case Investigation_ <a href="/en/lr/25787/">document type</a>.

## Safety Case Investigation Action Items {#action-items}

Use _Safety Case Investigation Action Items_ to support managing investigations. You can add tasks and assign them to specific users, and they can mark _Action Items_ as complete. To assign a task to a user, in the _Action Items_ section of a _Late Case Assessment_, select **Create** and complete the following fields:

* **Description**: Enter a description or instructions for the task.
* **Assigned To**: Select the user to whom you are assigning the task. 
* **Due Date**: Enter the date by which the task must be completed. 

Assignees can mark _Action Items_ as <a href="/en/lr/01151/#mark-an-action-item-as-complete">complete</a>.

[1]: #late-case
[2]: #action-items