{"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":"2026-05-29T09:55:04","modified_gmt":"2026-05-29T16:55:04","slug":"modify-multi-institutional-study","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/modify-multi-institutional-study\/","title":{"rendered":"Modify Approved Multi-institutional Study"},"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\/study-activities\/modify-multi-institutional-study\/print\/\" title=\"Print\" rel=\"nofollow\" target=\"_blank\">Print<\/a><\/p>\n<div class=\"table-of-contents\">\n<h2 id=\"toc\">Table of Contents<\/h2>\n<ul class=\"list-unstyled\">\n<li><a href=\"#1\">Before You Begin<\/a>\n<ul>\n<li><a href=\"#1a\">What\u2019s the difference between study modifications and site modifications?<\/a><\/li>\n<li><a href=\"#1b\">How do I know what type of modification to submit?<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#2\">Steps for Study Modifications<\/a><\/li>\n<li><a href=\"#3\">Steps for Site Modifications<\/a><\/li>\n<li><a href=\"#4\">After Modification Approval<\/a><\/li>\n<\/ul>\n<\/div>\n<h2 id=\"1\">Before You Begin<\/h2>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\" id=\"1a\">\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\">What\u2019s the difference between study modifications and site modifications?<\/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>A <strong>study-level modification<\/strong> is used when a change applies to the <strong>overall study<\/strong>, including all participating sites. This also includes changes that affect both the study and its sites.<\/p>\n<p>A <strong>site-level modification<\/strong> is used when a change applies to <strong>one specific participating site only<\/strong> and does not affect the overall study or other sites.<\/p>\n<p>In multi-site studies, modifications may be required at the study level, the site level, or both, depending on the change requested and how the study is set up in Zipline.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"1b\">\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\">How do I know what type of modification to 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<p>Start by determining the <strong>scope of the change<\/strong>:<\/p>\n<p>If the change applies to the <strong>overall study<\/strong>, submit a <strong>study-level modification<\/strong>. For more information:<\/p>\n<ul>\n<li><a href=\"\/research\/hsd\/irb-reliances\/single-irb\/uw-irb-as-a-single-irb\/steps-in-the-single-irb-review-process-follow-ons\/#studymod\">Study-level modifications process<\/a><\/li>\n<li><a href=\"\/research\/hsd\/training\/zipline-online-help-library\/modifications-to-uw-reviewed-studies\/\">Study-level modifications instructions<\/a><\/li>\n<\/ul>\n<p>If the change applies to <strong>one specific site only<\/strong>, submit a <strong>site-level modification<\/strong>. For more information:<\/p>\n<ul>\n<li><a href=\"\/research\/hsd\/irb-reliances\/single-irb\/uw-irb-as-a-single-irb\/steps-in-the-single-irb-review-process-follow-ons\/#sitemod\">Site-level modifications process<\/a><\/li>\n<li><a href=\"#3\">Site-level modifications instructions<\/a><\/li>\n<\/ul>\n<p>If the change affects <strong>both the study and one or more sites<\/strong>, submit a <strong>study-level modification first<\/strong>.<\/p>\n<p>HSD strongly recommends waiting to submit any sit- level modifications until the study-level modification has been reviewed. During review, HSD staff will evaluate whether a site modification is also required and will provide instructions on when and what to submit.<\/p>\n<p>Because requirements can vary based on how the study is configured in Zipline, it may not always be clear which modification is needed. If you are unsure, contact <a href=\"mailto:hsdrely@uw.edu\">hsdrely@uw.edu<\/a> for guidance before submitting.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<h2 id=\"2\">Steps for Study Modifications<\/h2>\n<p>The steps for multi-site study-level modifications are the same as the steps for single-site study modifications. Go to <a href=\"\/research\/hsd\/training\/zipline-online-help-library\/modifications-to-uw-reviewed-studies\/\">Modifications to UW Reviewed Studies<\/a> for detailed steps.<\/p>\n<h2 id=\"3\">Steps for Site Modifications<\/h2>\n<p>Site modifications apply to a single participating site. If HSD requires changes, they will withdraw the modification because clarification requests are not available for site modifications. The PI or PI proxy must resubmit the modification before review can continue.<\/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: 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=\"\/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<\/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 draft version of the site submission and should be on the Basic Site Information page. Update the draft submission to reflect the proposed modification by revising the Site SmartForms as needed and uploading any new or updated documents.<\/li>\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=\"\/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=\"\/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=\"\/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=\"\/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=\"\/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<p>&nbsp;<\/p>\n<p>&nbsp;<\/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: HSD Withdraws Site Modification (If Additional Information Needed)<\/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>Important:<\/strong> Site modifications do not have a formal clarification request process. If HSD needs additional information or changes before approval, they will <strong>withdraw the site modification<\/strong> and return it to <strong>Pre-Submission<\/strong> with reviewer comments. You must address the requested changes and <strong>resubmit<\/strong> the modification for HSD to continue review.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-40547 size-large\" src=\"\/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<ul>\n<li>When the submission is withdrawn, an automatic notification is sent to the PI, any PI proxies, and the parent study\u2019s primary contact.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-40548 \" src=\"\/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 5: 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=\"\/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 6: 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=\"\/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 7: 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, 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=\"\/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<h2 id=\"4\">After Modification Approval<\/h2>\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 UW PI, PI proxy, and primary contact also receive a notification containing the modification approval letter.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Table of Contents Before You Begin What\u2019s the difference between study modifications and site modifications? How do I know what type of modification to submit? Steps&#8230;<\/p>\n","protected":false},"author":158,"featured_media":0,"parent":11143,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-37215","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Modify Approved Multi-institutional Study - UW Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/modify-multi-institutional-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Modify Approved Multi-institutional Study - UW Research\" \/>\n<meta property=\"og:description\" content=\"Table of Contents Before You Begin What\u2019s the difference between study modifications and site modifications? 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How do I know what type of modification to submit? 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