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How to Guide 004: How to Submit a Deviation or Adverse Event Report

Introduction

• Purpose of the Guide- The purpose of this guide is to provide step-by-step instructions for submitting a deviation or adverse event report to the Institutional Animal Care and Use Committee (IACUC). The purpose of submitting a deviation or adverse event report to the IACUC is to:
  • Monitor compliance with approved protocols.
  • Identify and address any issues that may arise and implement corrective actions to prevent recurrence.
  • Maintain the integrity of the research.
  • Fulfill regulatory and institutional requirements.
• Scope/Audience- Principal Investigators (PIs), PI Groups 

Getting Started

Step 1: Logging into the Cayuse system-

Step 2: Navigating to the Animal Oversight module- While on your Home page, select 鈥淎nimal Oversight鈥� from the 鈥淧roducts鈥� drop-down menu.

Creating and Submitting Protocol Amendments

Initiating a Deviation/Adverse Event Report via an Amendment 

You can select the 鈥淧rotocol Actions鈥� tab from the tiered column on the lefthand side of your screen or you can select the 鈥淧rotocol Actions (?)鈥� tab that runs along the horizonal banner. The Protocol Actions subsection will allow you to start a new protocol or start an amendment to an existing protocol.  

The Amendment form is used to capture deviations and adverse events. To begin, highlight the protocol you wish to amend, and then select 鈥淪tart an Amendment鈥�. 

Amendment Overview 

On the amendment landing page, please use the space highlighted below to provide a brief statement that the purpose of the amendment is to submit a deviation and or adverse event report to the IACUC. You may also include an overview of proposed changes in this space. 

Deviation/Events Section

Use the scroll bar along the Table of Contents to navigate to the Deviation/Adverse Events section of the form. Click on the section header highlighted below to begin. 

Event Details

This section serves a dual purpose. First, to obtain details regarding deviations to the approved protocol throughout the lifespan of the protocol and two, to capture details of adverse events that occur throughout the life of the protocol.

1.  If you need to report a deviation, select 鈥淵es鈥� to 鈥淎re you reporting a deviation?鈥� and provide the details prompted by secondary question.
2. If you need to report an adverse event, select 鈥淵es鈥� to 鈥淎re you reporting an adverse event?鈥� and provide the details prompted by secondary question.

NOTE: If adding an additional deviation or event, be sure to keep the historical text and enter the new information stating with the date of occurrence and location. The purpose of this section is act as a running log of events that occur throughout the life of the protocol.

Submitting Deviation and Adverse Event Reports for Review

• Submission process- To submit your amendment for IACUC review, please first take the time to read over terms outlined on the Submit Protocol page. Next, press 鈥淪ubmit Protocol鈥� 

• Tracking submission status- On your Animal Oversight Homepage, you can click on the tab Protocols in Review and view each submission that is currently moving through the review process. In the example below, you can see that the highlighted submission has been moved to the IACUC Office for routing. You can return to this page to monitor the progress of your submission. 

TIP! Please if you like to learn more about prompt reporting requirements and how the IACUC assesses and manages reports of noncompliance and adverse events, please view 鈥�IACUC Procedure 001- Managing Noncompliance & Animal Welfare Concerns"