Regulatory Management: Termination Report

Overview

A Termination Report is used only for terminating an approved study or expanded access application upon completion of the research. Once the report is finalized, the application will be terminated and archived. Once archived, you cannot modify or use the application for research going forward.

Navigation

Role: PI/Study Team Member > Home Workspace

Step-by-Step Process

Create a New Termination Report (for Approved studies)

1. Click the Approved tab.
   
2. Click the study Name.
3. Click the Termination Report button.
   
4. Enter or verify the Termination Report Title.
   Note If you edit the title, include the HUM # of the original study to make tracking easier.
   
5. Click Continue.
6. Complete the required information on each page of the Termination Report.
7. Click Submit Scheduled Continuing Review.
   Notes
   • If applicable, use important Validate (Hide/Show Errors) to check for and correct any errors before submitting the report.
   • Click Save if you are not yet ready to submit.
     
8. Click OK.
   

Once the Termination Report is processed, go to the Archived tab in the Home Workspace to view the application.