Regulatory Management: Administrative Withdrawal

Overview

The Administrative Withdrawal activity is used primarily as a “housekeeping” tool to remove submissions that no longer need to be stored in the system (e.g., when a submission has sat in a State of Changes Required for an extended period of time with no progress).

The Administrative Withdrawal activity is only available for submissions in the following States:

• Changes Required
• Contingencies Pending
• Approved
• Expired

Navigation

Role: Core Committee Staff > Home Workspace

Step-by-Step Process

1. Click the Core Committee Staff Role, or verify it is selected.
   
2. Click the Completed tab.
3. Click the Submission ID.
   Important
   • You must click the Submission ID to open the Study Workspace, not the Study Name. Clicking the Name takes you directly to the Core Committee Staff Review page.
   • Submission State displays the current state of the submission.
   • Staff Notes displays the last action that was performed on the submission.
4. Click the Administrative Withdrawal or Termination activity.
   
5. Click the Withdrawal radio button.
   
6. If applicable, enter any Notes.
7. Click OK.