Regulatory Management: Submitting Contingencies

Overview

In some cases, submissions may be approved with contingencies. Prior to full approval, study teams must submit additional information to satisfy the contingencies. The study team receives a Contingencies Letter via email, which includes a link to the study. The Outstanding Issues table at the bottom of the Study Workspace lists all contingencies to be addressed. The Current State of the study is Contingencies Pending.

Navigation

Role: Study Team Member  > Home Workspace > Study Workspace

Step-by-Step Process

1. Locate the Outstanding Issues table at the bottom of the Study Workspace and review all Identified Issues.
   
2. Click Edit Study and make all necessary changes.
   Note If available, you can also click the blue Section links in the Outstanding Issues table to navigate directly to those sections of the study application.
   
3. Click the Submit Contingencies activity.
   Note The system validates that all required fields on the study application are complete. Any errors must be addressed before submitting contingencies.
4. Click the applicable radio button to Indicate the changes you have made in response to the identified issues.
   
5. If applicable, enter Comments.
6. Click OK.

After submitting contingencies, the study application returns to the committee for review and the Current State of the study changes to reflect this (e.g., Core Committee Staff Contingency Review).