UW Research

Respond to HSD

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Table of Contents

Overview

Two different situations require the study team to respond to HSD in order to move the site review forward.

  • Modifications Required to Secure Approval (MRSA): The IRB may determine that the site requires changes (or the IRB requires additional information) before the site can be activated. A formal letter is emailed listing the required changes and moving the site to the Modifications Required state.

screenshot of a site in MRSA state

  • Deferral: When the convened IRB requests significant additional information in order to complete the site review, a formal letter is emailed and the site moves to Deferred state.

screenshot of a site in deferred state

In both scenarios:

  • The PI, any PI proxies, and the study’s primary contact receive an e-mail notification and the study appears in My Inbox.
  • A member of the study team may need to edit the related documents and/or SmartForms based on HSD or the IRB’s request.

Responding to a Site Deferral

1. Locate the Deferral letter in the Site Workspace- it will be the most recent letter sent for the site

screenshot of a site deferral letter

2. Prepare your written response. Write a point-by-point response letter by creating a new Word document, copying the letter into the document, and responding to each point. Number your responses to match the points listed in the original letter to facilitate the IRB’s review.

3. Update any new or revised site documents and/or SmartForms as needed. See the Edit Documents and Edit SmartForms section for detailed steps.

4. In the site workspace, click Add Comment, and attach your response letter as a supporting document. Indicate that the IRB Coordinator should receive an email notification.

screenshot of a comment with a site deferral response

screenshot of a comment with a site deferral response

Responding to a Site MRSA (Modifications Required to Secure Approval)

1. Locate the MRSA letter in the Site Workspace- it will be the most recent letter sent for the site

screenshot of a site MRSA letter

2. Prepare your written response. Write a point-by-point response letter by creating a new Word document, copying the letter into the document, and responding to each point. Number your responses to match the points listed in the original letter to facilitate the IRB’s review.

3. Update any new or revised site documents and/or SmartForms as needed. See the Edit Documents and Edit SmartForms section for detailed steps.

4. In the site workspace, complete the Submit Response activity and attach your response letter as a supporting document

screenshot of the submit response activity

screenshot of the completed submit response activity