> For the complete documentation index, see [llms.txt](https://interfacing.gitbook.io/interfacing-help-files/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://interfacing.gitbook.io/interfacing-help-files/regulatory-compliance/sensitive-events-application.md).

# Managing Sensitive Events (Apps)

Use the Sensitive Event(s) application to report, track, and manage sensitive events across the organization.

### Overview

**Sensitive Event** is a structured, workflow-driven app designed to manage the reporting, review, and resolution of sensitive events. It provides a controlled framework to ensure that reported issues are properly reviewed, investigated, and resolved through timely containment and follow-up actions.

All reported events are logged, assigned, and tracked in a centralized system, supporting visibility, accountability, and compliance with organizational requirements.

***

### Application Prerequisites

Before users can work with the **Sensitive Event** app, administrators must configure the following settings:

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<p align="center"><mark style="color:blue;"><strong>General Settings</strong></mark></p>

<i class="fa-location-dot">:location-dot:</i> **Locations**

Define geographical locations used throughout the app, including **Regions**, **Countries**, and **Sites**.

<i class="fa-landmark">:landmark:</i> **Compliance Program, Frequency & Category**

Configure options used to classify, schedule, and organize sensitive event reporting and follow-up activities.

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<p align="center"><mark style="color:blue;"><strong>Action Item Settings</strong></mark></p>

<i class="fa-hourglass-clock">:hourglass-clock:</i> **Durations**

Define and manage durations for effectiveness checks and action item follow-ups.

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{% hint style="success" %} <mark style="color:red;">For detailed setup instructions, see Sensitive Events Settings.</mark>
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### Accessing the App

To open the **Sensitive Event** application:

1. Click the **Apps** tile in the side navigation bar.
2. On the **Apps** page, either:
   * Select **Sensitive Event** from the navigation tree, or
   * Go to the **QMS** category in the main workspace and select **Sensitive Event**.

<p align="center">[IMAGE]</p>

The application opens, displaying its available modules.

<table data-card-size="large" data-view="cards"><thead><tr><th></th></tr></thead><tbody><tr><td><i class="fa-circle-plus">:circle-plus:</i>  <strong>Create a Sensitive Event</strong><br><br>Use this module to create and submit a new sensitive event report for review and processing.</td></tr><tr><td><i class="fa-list-radio">:list-radio:</i>  <strong>Sensitive Event List</strong><br><br>Use this module to view and track all reported events throughout the investigation and resolution workflow.</td></tr></tbody></table>

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### Learn More

Refer to the following guides for detailed instructions:

<table data-view="cards"><thead><tr><th></th><th><select multiple><option value="bbLcf8Qg1Elh" label="Reporter" color="blue"></option><option value="JALbwYa2at7y" label="Reviewer" color="blue"></option><option value="r3voRIimAqfU" label="Investigator" color="blue"></option><option value="uPwTvzVDvxgI" label="Approver" color="blue"></option></select></th><th></th><th data-hidden data-card-cover data-type="image">Cover image</th><th data-hidden data-card-target data-type="content-ref"></th></tr></thead><tbody><tr><td><strong>How to Navigate the Sensitive Event Workflow</strong><br><br>Perform assigned tasks to advance event reports.<br><br>Roles</td><td><span data-option="bbLcf8Qg1Elh">Reporter, </span><span data-option="JALbwYa2at7y">Reviewer, </span><span data-option="r3voRIimAqfU">Investigator, </span><span data-option="uPwTvzVDvxgI">Approver</span></td><td>Related Module(s)<br><i class="fa-circle-plus">:circle-plus:</i> <strong>Create a Sensitive Event</strong></td><td><a href="https://1488562728-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2FTx7AmE0d2Q4ja20EYjF5%2Fuploads%2FRXCPVVBQHOYD1dlUEvte%2FIMS-V16-Apps-Overview-12.png?alt=media&amp;token=6bd65335-5eb8-460a-ad87-ab9963e1a312">IMS-V16-Apps-Overview-12.png</a></td><td><a href="/interfacing-help-files/regulatory-compliance/sensitive-events-application/navigating-the-sensitive-events-workflow.md">Navigating the Sensitive Events Workflow</a></td></tr><tr><td><strong>How to Track &#x26; Monitor Sensitive Events</strong><br><br>Monitor the status and progress of sensitive event reports.<br><br>Roles</td><td><span data-option="bbLcf8Qg1Elh">Reporter, </span><span data-option="JALbwYa2at7y">Reviewer, </span><span data-option="r3voRIimAqfU">Investigator, </span><span data-option="uPwTvzVDvxgI">Approver</span></td><td>Related Module(s)<br><i class="fa-list-radio">:list-radio:</i>  <strong>Sensitive Event List</strong></td><td><a href="https://1488562728-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2FTx7AmE0d2Q4ja20EYjF5%2Fuploads%2FNZOvD3ldHJ3i1zsvDksS%2FCR-V16-Icons-1.png?alt=media&amp;token=7c420cc4-9abf-4601-8fc3-8e9769771b27">App-V16-Icons-1.png</a></td><td><a href="/interfacing-help-files/regulatory-compliance/sensitive-events-application/tracking-and-monitoring-sensitive-events.md">Tracking &amp; Monitoring Sensitive Events</a></td></tr></tbody></table>


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