{"id":31079,"date":"2019-12-31T10:16:20","date_gmt":"2019-12-31T18:16:20","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=31079"},"modified":"2026-01-30T10:22:51","modified_gmt":"2026-01-30T18:22:51","slug":"modifications-to-uw-reviewed-studies","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/modifications-to-uw-reviewed-studies\/","title":{"rendered":"Modifications to UW Reviewed 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\/modifications-to-uw-reviewed-studies\/print\/\" title=\"Print\" rel=\"nofollow\" target=\"_blank\">Print<\/a><\/p>\n<p>Review <a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/modify\/\">Modify the Approved Study<\/a> for an overview of the modification process, including which review types require modifications.<\/p>\n<h2>How to Modify an Approved Study<\/h2>\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: Edit Approved Study Documents and Prepare New Documents<\/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>Always use the currently approved version of the document that you need to edit, accept any previous tracked changes, and make sure tracked changes are enabled before making edits. Make sure you update any document dates and version numbers too!<\/p>\n<p><strong>Previously Approved Documents:<\/strong> In the <strong>Documents<\/strong> tab, open the Final version of the document to be edited<\/p>\n<ul>\n<li><strong>FOR CONSENT FORMS<\/strong>: Because the final version is a PDF, select the draft version in Word instead of the final version. In some cases, this document may contain tracked changes and comments that have been accepted in the final version. If so, use the review features in Word to accept all the changes and remove any comments, and use this clean document as a starting point for your revisions.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31083 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Final-Version.png\" alt=\"screenshot of documents tab highlighting the final version\" width=\"1068\" height=\"475\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Final-Version.png 1068w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Final-Version-300x133.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Final-Version-768x342.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Final-Version-1024x455.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Final-Version-375x167.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Final-Version-750x334.png 750w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li>Make document edits and save the document to your computer<\/li>\n<\/ul>\n<p><strong>To aid in HSD\u2019s review:<\/strong><\/p>\n<ul>\n<li>Make sure <a href=\"https:\/\/support.microsoft.com\/en-us\/office\/track-changes-in-word-197ba630-0f5f-4a8e-9a77-3712475e806a\">Track Changes is enabled<\/a> before making changes<\/li>\n<li>Update the date and version number in the header\/footer of your document as needed<\/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 Zipline 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 study workspace, select Modify Study<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31087 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modify-Study.png\" alt=\"screenshot of modify study button\" width=\"270\" height=\"315\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modify-Study.png 270w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modify-Study-257x300.png 257w\" sizes=\"auto, (max-width: 270px) 100vw, 270px\" \/><\/p>\n<ul>\n<li>Select Modification\/Update as the purpose\n<ul>\n<li><strong>HSD recommends creating 2 separate submissions instead of a combined modification and continuing review<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31085 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Purpose.png\" alt=\"screenshot of modification purpose question\" width=\"970\" height=\"261\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Purpose.png 970w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Purpose-300x81.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Purpose-768x207.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Purpose-375x101.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Purpose-750x202.png 750w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li>Select \u201cOther parts of the study\u201d as the modification scope (select study team member information if you also need to update Zipline access)<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31086 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Scope.png\" alt=\"screenshot of modification scope question\" width=\"469\" height=\"104\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Scope.png 469w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Scope-300x67.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Modification-Scope-375x83.png 375w\" sizes=\"auto, (max-width: 469px) 100vw, 469px\" \/><\/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 the Modification Information 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<ul>\n<li>Complete the Modification Information SmartForm page, including a summary of your modifications and click Continue\n<ul>\n<li>If the modification is in response to a Report of New Information (RNI), note this in the modification summary and link the modification and RNI in the RNI workspace<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31084 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Mod-Info.png\" alt=\"screenshot of modification information page\" width=\"953\" height=\"735\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Mod-Info.png 953w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Mod-Info-300x231.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Mod-Info-768x592.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Mod-Info-375x289.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Mod-Info-750x578.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 4: Update the Zipline Application, including Uploading Revised Documents<\/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 study SmartForm and should be on the Basic Information page. Update the draft version of the study by making all needed revisions to the Study SmartForms and uploading any revised or new documents.<\/li>\n<\/ul>\n<p><strong>To Update a Document: <\/strong><\/p>\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<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31090 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Update-Document.png\" alt=\"screenshot of update button to update a study document\" width=\"699\" height=\"178\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Update-Document.png 699w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Update-Document-300x76.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Update-Document-375x95.png 375w\" sizes=\"auto, (max-width: 699px) 100vw, 699px\" \/><\/p>\n<p><strong>To Add a New Document:\u00a0<\/strong><\/p>\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<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31082 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Add-Document.png\" alt=\"screenshot of add document button\" width=\"661\" height=\"154\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Add-Document.png 661w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Add-Document-300x70.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Add-Document-375x87.png 375w\" sizes=\"auto, (max-width: 661px) 100vw, 661px\" \/><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\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<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31088 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Remove-Document.png\" alt=\"screenshot of x button to remove document\" width=\"657\" height=\"146\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Remove-Document.png 657w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Remove-Document-300x67.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Remove-Document-375x83.png 375w\" sizes=\"auto, (max-width: 657px) 100vw, 657px\" \/><\/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 5: Review Modification for Completeness<\/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>Checking the application for errors and omissions helps you to include all the relevant information, which is essential for receiving a timely review of your modification.<\/strong> Automatic system error checking identifies any omitted answers to questions that are required for every application. A red asterisk (*) indicates required questions.<\/p>\n<p>HSD also recommends looking over the forms to see what you may have missed, especially:<\/p>\n<ul>\n<li>Questions that are relevant to your study but are not required for all studies (no asterisks)<\/li>\n<li>Documents that should be attached<\/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 6: Principal Investigator (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<p>The Submit activity must be completed once the modification is ready to go to HSD. This activity must be completed by the PI or the PI Proxy.<\/p>\n<ul>\n<li>Select Submit in the modification workspace and provide required verifications<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31089 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Submit.png\" alt=\"screenshot of submit button for a study modification\" width=\"255\" height=\"242\" \/><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31091 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Verify-Submit.png\" alt=\"screenshot of ok button to verify modification submittal\" width=\"680\" height=\"389\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Verify-Submit.png 680w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Verify-Submit-300x172.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Study-Modifications-UW-Reviewed-Studies-Verify-Submit-375x215.png 375w\" sizes=\"auto, (max-width: 680px) 100vw, 680px\" \/><\/p>\n<p>The study transitions to Pre-Review state and is now in HSD\u2019s queue for review.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Review Modify the Approved Study for an overview of the modification process, including which review types require modifications. How to Modify an Approved Study &nbsp; &nbsp;&#8230;<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":9048,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-31079","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>Modifications to UW Reviewed Studies - 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\/training\/zipline-online-help-library\/modifications-to-uw-reviewed-studies\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Modifications to UW Reviewed Studies - UW Research\" \/>\n<meta property=\"og:description\" content=\"Review Modify the Approved Study for an overview of the modification process, including which review types require modifications. 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