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Submitting New Sites

Site submissions are only created for collaborative or multi-site studies where the UW is reviewing the activities of one or more other institution. The site submission only addresses the involvement of the relying institution, and it is approved separately from the overall study. The overall study must be approved before the relying sites can be activated. However, HSD staff may begin establishing the reliance agreements between the UW and each site while the study is being reviewed.

To learn more about when UW should review for other involved institutions, see Is the UW IRB the Right IRB? [1] Contact hsdrely@uw.edu [2] with any questions.

Watch this video for a short overview on adding a new site to an approved multi-site or collaborative study in Zipline:

 

Table of Contents

Initial Steps [3]
Completing the SITE Submission [4]
Submit SITE and Communicate with HSD [5]
Site Activation [6]

Initial Steps

Researcher Requests Addition of Sites

The process to request that HSD add a site that is relying on the UW for IRB review begins with the study application. Make sure that you’ve indicated that the UW should review for other institutions [7] on the study Basic Information SmartForm. Additionally, you’ll need to fill out the SUPPLEMENT Multi-site or Collaborative Research [8] and attach it to the study application in Zipline.

HSD Creates Sites in Zipline

In contrast to the overall study submission, which is created in Zipline by the study team, the site submission shell is created by HSD staff after the overall study is approved. Once the study, or modification requesting the addition of sites, is approved in Zipline, HSD will create a Zipline site submission shell for each site listed in the SUPPLEMENT Multi-site or Collaborative Research [8]. You will be notified when the sites submission shells have been created so that you can begin work on the SITE submissions.

Researcher Completes and Submits Sites for Review

HSD recommends that you prepare your site-specific materials before completing the Zipline SITE submission [4]:

  1. SUPPLEMENT Site Application (Contact) [9] or SUPPLEMENT Site Application (No Contact) [10], depending on the nature of the research; and
  2. Any additional site-specific materials, such as a site-specific consent form.

Completing the SITE Submission

1. Navigate to the SITE submission in Zipline

screenshot of an approved multi-site study showing the sites tab

2. Click Edit Site to complete the SmartForms and upload required documents

screenshot of the edit site button in Zipline

Submit SITE And Communicate with HSD

Because the site submission workflow in Zipline does not include a formal clarification request loop like most other submission types, HSD will use comments to communicate back and forth with researchers about their SITE submissions. The site submission should remain in the Invitation Pending state throughout the review.

screenshot of the site review process diagram

1. When the materials are ready for review, notify HSD by adding a comment to the SITE submission and notifying the IRB Coordinator

screenshot of a Zipline comment showing the PI notifying HSD that the site is ready for review

2. If you need to take additional action, HSD will notify you by adding a comment to the SITE submission

screenshot of the comment notification

screenshot of an HSD screening letter attached as a comment

Site Activation

When a site is activated, the UW PI, PI proxies, and primary contact receive an email notification. The UW study team is responsible for notifying the site and delivering approved materials.

See Managing Multi-site Studies [11] for more information on continuing review, closure, and modifications.