{"id":37215,"date":"2021-01-21T15:24:17","date_gmt":"2021-01-21T23:24:17","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=37215"},"modified":"2025-11-19T13:28:52","modified_gmt":"2025-11-19T21:28:52","slug":"managing-multi-site-studies","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/managing-multi-site-studies\/","title":{"rendered":"Managing Multi-institutional Studies"},"content":{"rendered":"<p><img decoding=\"async\" class=\"WP-PrintIcon\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/plugins\/wp-print\/images\/printer_famfamfam.gif\"  alt=\"Print\" title=\"Print\" style=\"border: 2px;\">&nbsp;<a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/managing-multi-site-studies\/print\/\" title=\"Print\" rel=\"nofollow\" target=\"_blank\">Print<\/a><br \/>\nWhen a multi-institutional study is initially approved, the IRB first approves the overall study protocol and the involvement of the UW. After that, the IRB will review site specific information for each relying institution and approve each site separately. See <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/submitting-new-sites\/\">Submitting New Sites<\/a> for detailed instructions on this process.<\/p>\n<p>Actions that may be needed for multi-site studies:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/submitting-new-sites\/\">Submitting New Sites<\/a><\/li>\n<li><a href=\"#CR\">Multi-site Study Continuing Review or Closure<\/a><\/li>\n<li><a href=\"#site closure\">Site Closure<\/a><\/li>\n<li><a href=\"#modifications\">Multi-site Study Modifications<\/a>\n<ul>\n<li><a href=\"#submitsitemod\">How to Submit Site Modifications<\/a><\/li>\n<li><a href=\"#sitemodcomms\">Communicating with HSD During Site Modification Review<\/a><\/li>\n<li><a href=\"#sitemodapproval\">After Modification Approval<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2 id=\"CR\">Multi-site Continuing Review or Closure<\/h2>\n<p>Continuing review is conducted at the study level. Any information about other institutions relying on the 天美影院for review should be reported with the overall study continuing review. The last day of approval for a site is the same as the last day of approval for the study overall.<\/p>\n<p>The continuing review report is used both for study renewal and study closure. When you indicate on the continuing review SmartForm that the first four research milestones have been met for the entire study, Zipline prompts you to acknowledge that the study will be closed. These milestones indicate that all enrollment, interventions, and analysis of subjects\u2019 private identifiable information are complete at all sites.<\/p>\n<p>The continuing review report has two parts:<\/p>\n<ul>\n<li>The Continuing Review SmartForm page in Zipline<\/li>\n<li>The <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/application-status-report-renew-or-close\/\">Status Report form<\/a> that you complete and then attach to the SmartForm<\/li>\n<\/ul>\n<h3>How to Submit Multi-site Continuing Review<\/h3>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 1: Create the Continuing Review in Zipline<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Click <strong>Renew or Close<\/strong> in the study workspace\n<ul>\n<li>The study must be Approved, Lapsed, or Suspended for this action to be available.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37225 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-Renew-or-Close-1.png\" alt=\"screenshot of the renew or close button in the study workspace\" width=\"1024\" height=\"387\" \/><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Indicate that the purpose of the submission is continuing review and click <strong>Continue <\/strong><\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37224 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-purpose.png\" alt=\"screenshot of the submission purpose showing continuing review selected\" width=\"1024\" height=\"441\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-purpose.png 1162w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-purpose-300x129.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-purpose-1024x441.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-purpose-768x330.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-purpose-375x161.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-purpose-750x323.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-purpose-1140x491.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 2: Complete the Continuing Review\/Study Closure Page<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Your responses should include information for all participating sites.<\/strong><\/p>\n<ul>\n<li>The total enrollment for Psites, or participating sites, with completed reports is a system generated function that 天美影院is not currently using. You can ignore this.<\/li>\n<li>You will be prompted to acknowledge that the study will be closed if the first 4 research milestones are selected.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37240 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-study-closure.png\" alt=\"screenshot of a continuing review indicating study closure\" width=\"1024\" height=\"274\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-study-closure.png 1129w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-study-closure-300x80.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-study-closure-1024x274.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-study-closure-768x205.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-study-closure-375x100.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-study-closure-750x201.png 750w\" sizes=\"auto, 100vw\" \/><\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 3: Complete and upload the Status Report form<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Complete and upload the <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/application-status-report-renew-or-close\/\">Status Report form<\/a>. If your study requires radiation safety approval at UW, you should also attach your radiation safety renewal here.<\/p>\n<ul>\n<li>Click the link to open the template<\/li>\n<li>Complete the template and save it to your computer<\/li>\n<li>Attach the template to the SmartForm, either using drag and drop, or by clicking <strong>Add<\/strong><\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37242 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-upload-CR.png\" alt=\"screenshot of the continuing review attachment\" width=\"1024\" height=\"224\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-upload-CR.png 1166w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-upload-CR-300x66.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-upload-CR-1024x224.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-upload-CR-768x168.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-upload-CR-375x82.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-upload-CR-750x164.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-upload-CR-1140x249.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Click <strong>Save <\/strong>and<strong> Exit <\/strong>to leave the SmartForm and return to the submission workspace<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 4: PI or PI proxy must submit<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Click Submit and complete required verifications<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37241 size-medium\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-submit-CR.png\" alt=\"screenshot of the the submit button\" width=\"262\" height=\"300\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-submit-CR.png 277w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-submit-CR-262x300.png 262w\" sizes=\"auto, (max-width: 262px) 100vw, 262px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>The continuing review transitions to Pre-Review state and is now in HSD\u2019s queue for review.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37223 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-CR-in-Pre-Review.png\" alt=\"screenshot of the continuing review workspace in Pre-Review\" width=\"1024\" height=\"288\" \/><\/p>\n<p>After the IRB has reviewed the application, the PI, any PI proxies, and primary contact will receive a notification that:<\/p>\n<ul>\n<li>The IRB has approved the renewal or closure; OR<\/li>\n<li>The IRB requires more information or a change before approving the renewal or closure<\/li>\n<\/ul>\n<p>Review <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/respond-to-hsd\/\">Respond to HSD<\/a> for more information on submitting responses.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<h3>After Continuing Review Approval<\/h3>\n<p>After the continuing review is approved, the parent study will be updated. For closure requests, the parent study and all participating sites are closed. For renewal requests, the new expiration date is published to the parent study and applies to all participating sites. The PI, PI proxy, and primary contact also receive a notification containing the Continuing Review or Closure approval letter.<\/p>\n<h2 id=\"site closure\">Site Closure<\/h2>\n<p>If the involvement of a relying institution has ended, submit a site closure to the IRB. This closes the SITE record while leaving the parent STUDY record open. To close the study, follow the <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/managing-multi-site-studies\/#CR\">Multi-site Continuing Review or Closure instructions<\/a>.<\/p>\n<h3>How to Submit a Site Closure<\/h3>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 1: Locate and update the currently approved Multi-site or Collaborative Research Supplement<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>In the parent study for the site, locate and download the currently approved SUPPLEMENT: Multi-site or Collaborative Research in the Documents tab<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37228 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-find-supplement-2.png\" alt=\"screenshot of the study workspace showing the multi-site supplement in the documents tab\" width=\"1024\" height=\"350\" \/><\/p>\n<ul>\n<li>Update the SUPPLEMENT: Multi-site or Collaborative Research to remove the information for the site that you wish to close<\/li>\n<li>Save the revised SUPPLEMENT to your computer<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 2: Create a study modification in Zipline<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>In the parent study for the site, click Modify Study to initiate a study modification<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37231 size-medium\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-modify-study.png\" alt=\"screenshot of the modify study button\" width=\"241\" height=\"300\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-modify-study.png 322w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-modify-study-241x300.png 241w\" sizes=\"auto, (max-width: 241px) 100vw, 241px\" \/><\/p>\n<ul>\n<li>Indicate that the purpose of the submission is a modification\/update and the modification scope is \u201cOther parts of the study\u201d and click Continue<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37229 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-scope.png\" alt=\"screenshot of the modification scope\" width=\"1024\" height=\"421\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-scope.png 1307w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-scope-300x123.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-scope-1024x421.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-scope-768x316.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-scope-375x154.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-scope-750x308.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-scope-1140x468.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li>On the Modification Summary page, indicate that the involvement of a relying institution has ended and the site should be closed, and click Continue<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37230 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary.png\" alt=\"screenshot of the modification summary\" width=\"1024\" height=\"492\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary.png 1618w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary-300x144.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary-1024x492.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary-768x369.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary-1536x739.png 1536w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary-375x180.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary-750x361.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-mod-summary-1140x548.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 3: Update the Zipline study to remove information about the site<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>In the Zipline application, use the left hand navigator to go to the Study Related Documents page and locate the SUPPLEMENT: Multi-site and Collaborative Research<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37233 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement.png\" alt=\"screenshot of updating the multi-site supplement\" width=\"1024\" height=\"366\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement.png 1876w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement-300x107.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement-1024x366.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement-768x274.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement-1536x549.png 1536w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement-375x134.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement-750x268.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-update-supplement-1140x407.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li>Click UPDATE next to the SUPPLEMENT, select the revised version from your computer, and click OK<\/li>\n<li>If desired, you can make additional changes to your study application<\/li>\n<li>Save and exit the SmartForm<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 4: PI or PI proxy must submit study modification<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>In the modification workspace, click Submit to send the modification requesting site closure to HSD<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37232 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod.png\" alt=\"screenshot of the submit button\" width=\"1024\" height=\"377\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod.png 1740w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod-300x110.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod-1024x377.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod-768x282.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod-1536x565.png 1536w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod-375x138.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod-750x276.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-closure-submit-mod-1140x419.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<p>Once HSD has approved the modification updating the SUPPLEMENT: Multi-site and Collaborative Research, HSD staff will close the SITE record in Zipline.<\/p>\n<h2><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37227 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-Closed-Site.png\" alt=\"screenshot of a closed site\" width=\"1024\" height=\"196\" \/><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<h2 id=\"modifications\">Multi-site Modifications<\/h2>\n<p>Depending on the change requested, multi-site studies may need to be modified at the study level and\/or the participating site level. Because the type(s) of modifications will depend on the study and how it is set up in Zipline, it can be tricky to determine if a site modification is required.<\/p>\n<p><strong>To initiate any changes to a multi-site study or site: <\/strong><\/p>\n<p>First, consider whether the changes apply to the overall study only, to a specific site only or impact both the overall study and any sites. If you are uncertain, email <a href=\"mailto:hsdrely@uw.edu\">hsdrely@uw.edu<\/a>.<\/p>\n<p><strong>Study-level modifications.<\/strong> If the changes affect the overall study or both the study and sites, <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/modifications-to-uw-reviewed-studies\/\">submit a study level modification<\/a>. <b>HSD strongly recommends that you wait to submit the site level modifications until the study level modification has been reviewed.<\/b> HSD staff will automatically evaluate if a site modification is also required as part of the review process and will provide instructions about when and what to submit for a site level modification. If any related site modifications are needed, HSD staff will instruct you to create them. The PI or PI proxy must then submit the site modification before HSD staff can complete the review.<\/p>\n<p><strong>Site-level modifications.<\/strong> If the changes affect only a site, submit a site modification following these instructions:<\/p>\n<h3 id=\"submitsitemod\">How to Submit Site Modification<\/h3>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 1: Create Site Modification in Zipline<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>In the SITE workspace, click Create Site Modification<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37235 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod.png\" alt=\"screenshot of the create site modification button\" width=\"1024\" height=\"398\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod.png 1645w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod-300x117.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod-1024x398.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod-768x299.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod-1536x598.png 1536w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod-375x146.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod-750x292.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-create-site-mod-1140x444.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li>Complete the Modification Information SmartForm and click Continue<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 2: Update the Site record in Zipline<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>You are now in a <em>draft version<\/em> of the site SmartForm and should be on the Basic Site Information page. Update the draft version of the site to reflect any changes being made in the modification, by making all needed revisions to the Site SmartForms and uploading any revised or new documents.<\/li>\n<\/ul>\n<ul>\n<li><strong>To Update a Document:<\/strong>\n<ul>\n<li>Click Update<\/li>\n<li>Select the revised file from your computer<\/li>\n<li>Click OK in the Edit Attachment window<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37239 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-update.png\" alt=\"screenshot of updating a document\" width=\"1024\" height=\"153\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-update.png 1116w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-update-300x45.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-update-1024x153.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-update-768x115.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-update-375x56.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-update-750x112.png 750w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li><strong>To Add a New Document:<\/strong>\n<ul>\n<li>Click Add<\/li>\n<li>Select the new document from your computer<\/li>\n<li>Click OK in the Edit Attachment window<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37234 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-add.png\" alt=\"screenshot of adding a new document\" width=\"1024\" height=\"153\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-add.png 1116w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-add-300x45.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-add-1024x153.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-add-768x115.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-add-375x56.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-add-750x112.png 750w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li><strong>To Remove a Document:<\/strong>\n<ul>\n<li>Click the X by the document<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37237 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-remove.png\" alt=\"screenshot of removing a document\" width=\"1024\" height=\"153\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-remove.png 1116w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-remove-300x45.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-remove-1024x153.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-remove-768x115.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-remove-375x56.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-remove-750x112.png 750w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li>Click Save and Exit when you are finished editing the modification<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 3: PI or PI proxy must submit Site Modification<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Click <strong>Submit<\/strong> in the modification workspace. The Submit activity must be completed once the modification is ready to go to HSD.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37238 size-medium\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-submit.png\" alt=\"screenshot of the submit button\" width=\"178\" height=\"300\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-submit.png 338w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-submit-178x300.png 178w\" sizes=\"auto, (max-width: 178px) 100vw, 178px\" \/><\/p>\n<ul>\n<li>Click OK to provide required verifications<\/li>\n<\/ul>\n<p>The modification transitions to Pre-Review state and is now in HSD\u2019s queue for review.<\/p>\n<h3><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-37236 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview.png\" alt=\"screenshot of a site modification in Pre-Review\" width=\"1024\" height=\"343\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview.png 1720w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview-300x100.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview-1024x343.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview-768x257.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview-1536x514.png 1536w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview-375x126.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview-750x251.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-Studies-site-mod-prereview-1140x382.png 1140w\" sizes=\"auto, 100vw\" \/><\/h3>\n<\/div>\n<\/div>\n<\/div>\n<ul>\n<li style=\"list-style-type: none;\"><\/li>\n<\/ul>\n<h3 id=\"sitemodcomms\">Communicating with HSD During Site Modification Review<\/h3>\n<p>Site modifications do not have a formal clarification request process built in. Because of this, <strong>HSD will withdraw your site modification <\/strong>if more information is needed or a change is required before approving the modification. This pushes your site modification back to Pre-Submission. After completing any needed changes, you must resubmit to send the site modification back to HSD for review.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-40547 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Managing-Multi-site-studies-site-mod-pre-submission-diagram.png\" alt=\"screenshot of the site modification review diagram\" width=\"1024\" height=\"171\" \/><\/p>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 1: HSD Withdraws Site Modification<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>If additional information or changes are required, HSD will withdraw the site modification and an automatic notification will be sent to the PI, any PI proxies, and the primary contact of the parent study<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-40548 \" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/managing-multi-site-studies-withdrawal-notification.png\" alt=\"screenshot of a withdrawal notification sent from Zipline\" width=\"589\" height=\"161\" \/><\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 2: Study Team Edits the Site Modification<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Select Edit Modification and make any needed changes to the application<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-40545 \" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/managing-multi-site-studies-edit-modification.png\" alt=\"screenshot of the edit modification button in Zipline\" width=\"181\" height=\"310\" \/><\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 3: PI or PI proxy resubmits site modification to HSD<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Select Submit to send the site modification back to HSD for review<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-40546 \" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/managing-multi-site-studies-resubmit-modification.png\" alt=\"screenshot of the submit modification button in Zipline\" width=\"163\" height=\"279\" \/><\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 4: Add Comment to Notify IRB Coordinator<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Click <strong>Add Comment<\/strong> in the modification workspace. Indicate that you have provided the response to clarification and are resubmitting the Modification, check the box to notify the IRB coordinator, and click OK. This ensures that the correct IRB coordinator is notified.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-45153 \" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/site-mod-resubmit-add-comment.png\" alt=\"screenshot of adding a comment to resubmit a site modification \" width=\"593\" height=\"626\" \/><\/p>\n<\/div>\n<\/div>\n<\/div>\n<h3 id=\"sitemodapproval\">After Modification Approval<\/h3>\n<p>After the modification is approved, the changes are published in the site record, so the site always contains the currently approved information. The 天美影院PI, PI proxy, and primary contact also receive a notification containing the modification approval letter.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>When a multi-institutional study is initially approved, the IRB first approves the overall study protocol and the involvement of the UW. 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