{"id":31245,"date":"2020-01-02T10:22:09","date_gmt":"2020-01-02T18:22:09","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=31245"},"modified":"2024-12-10T09:47:18","modified_gmt":"2024-12-10T17:47:18","slug":"reports-of-new-information","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/reports-of-new-information\/","title":{"rendered":"Reports of New Information"},"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\/reports-of-new-information\/print\/\" title=\"Print\" rel=\"nofollow\" target=\"_blank\">Print<\/a><\/p>\n<h2>Table of Contents<\/h2>\n<ul>\n<li><a href=\"#submit\">Submit RNI<\/a><\/li>\n<li><a href=\"#respond\">Respond to Action Required<\/a><\/li>\n<\/ul>\n<p>Review <a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/report-events-and-new-information\/\">Report Safety\/Compliance Information<\/a> for an overview of reporting requirements and the RNI process.<\/p>\n<h2 id=\"submit\">Submit RNI<\/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: Create the Report of New Information<\/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 Report New Information from My Inbox, or from a related study or site<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31254 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Report-New-Information.png\" alt=\"screenshot of the Report New Information button\" width=\"280\" height=\"228\" \/><\/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 RNI Zipline SmartForm<\/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>Enter a short title for the submission (Question 1)\n<ul>\n<li>For most submissions <u>we recommend using the following format<\/u>: [PI Name]_[1-2 Word Descriptor of Event], e.g. Smith_Tachycardia SAE, Smith_DSMB Report, Smith_Revised IB<\/li>\n<\/ul>\n<\/li>\n<li>Enter the date you became<strong> aware<\/strong> of the information (Question 2)\n<ul>\n<li>For PAVE reports: enter the date you are submitting the PAVE report<\/li>\n<\/ul>\n<\/li>\n<li>Select the category (or categories) that best represents the new information being reported (Question 3)\n<ul>\n<li>For PAVE reports: Select Report as the category of new information<\/li>\n<\/ul>\n<\/li>\n<li>Describe the event and what, if any corrective action has been taken or is proposed (Question 4)\n<ul>\n<li>If a related modification will be submitted, please note this. If the modification has already been created, make sure to associate (link) it with the RNI in Question 6.<\/li>\n<\/ul>\n<\/li>\n<li>Indicate your assessment of the RNI regarding new or increased risk or safety issues, and whether the study and consent form need revisions<\/li>\n<li>Link any related studies, sites, and or modifications if applicable\n<ul>\n<li>Studies must be approved in Zipline in order to link the study to the RNI<\/li>\n<li>To add a related modification, first add the modification\u2019s parent study. After adding the parent study, the RNI SmartForm must also be saved before the modification can be added.<\/li>\n<li>Click the ellipsis<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31252 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Ellipsis.png\" alt=\"screenshot of the ellipsis button to select related studies and modifications\" width=\"1024\" height=\"118\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Ellipsis.png 1193w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Ellipsis-300x35.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Ellipsis-768x89.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Ellipsis-1024x118.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Ellipsis-375x43.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Ellipsis-750x87.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Ellipsis-1140x132.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Select the checkbox for the related study or modification and click <strong>OK<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31256 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Select-Study.png\" alt=\"Screenshot of associating a study with an RNI\" width=\"1024\" height=\"703\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Select-Study.png 1265w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Select-Study-300x206.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Select-Study-768x527.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Select-Study-1024x703.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Select-Study-375x257.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Select-Study-750x515.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Select-Study-1140x782.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: Upload the RNI Supplement and Other Supporting Documents (if applicable)<\/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><strong>The <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/supplement-rni\/\">RNI Supplement<\/a> is required for all RNIs submitted by researchers.<br \/>\n<\/strong><\/li>\n<li>You should also upload any documents related to the RNI, such as a copy of the DSMB report.<\/li>\n<li><strong>Never include identifiable subject information! <\/strong><\/li>\n<\/ul>\n<p>To Upload:<\/p>\n<ul>\n<li>Click Add<\/li>\n<li>Select the file to upload<\/li>\n<li>Click OK<\/li>\n<li>Save and Exit the SmartForm<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-45447 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/upload-RNI-documents.png\" alt=\"screenshot of the button to upload documents to an RNI in Zipline\" width=\"1024\" height=\"269\" \/><\/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: Manage Editors for the RNI Submission<\/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>Add study team members that you want to be able to edit and submit the new information. The PI and any PI proxies of linked studies automatically have edit permissions.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-54859 \" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/rniManageEditors.jpg\" alt=\"screenshot of the Manage Editors activity in a RNI submission in Zipline\" width=\"251\" height=\"378\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/rniManageEditors.jpg 548w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/rniManageEditors-199x300.jpg 199w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/rniManageEditors-375x565.jpg 375w\" sizes=\"auto, (max-width: 251px) 100vw, 251px\" \/><\/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: An RNI Editor must submit 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 Submit RNI and OK to complete the submission<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31258 size-medium\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Submit-RNI.png\" alt=\"Screenshot of the Submit RNI button in Zipline\" width=\"208\" height=\"300\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Submit-RNI.png 260w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Submit-RNI-208x300.png 208w\" sizes=\"auto, (max-width: 208px) 100vw, 208px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>The RNI 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-31253 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Pre-Review.png\" alt=\"screenshot of the RNI in Pre-Review state\" width=\"1024\" height=\"250\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Pre-Review.png 1237w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Pre-Review-300x73.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Pre-Review-768x187.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Pre-Review-1024x250.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Pre-Review-375x92.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Pre-Review-750x183.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Pre-Review-1140x278.png 1140w\" sizes=\"auto, 100vw\" \/><\/p>\n<\/div>\n<\/div>\n<\/div>\n<h2 id=\"respond\">Respond to Action Required<\/h2>\n<p>After reviewing a Report of New Information (RNI), the IRB may require specific actions to be taken in response to the reported issue. A responsible party is assigned by the IRB to complete the action. The responsible party or an RNI Editor can respond using the Submit Action Response activity when the action has been completed.<\/p>\n<p>The system sends an email to notify the responsible party and the submitter of the RNI, as well as the PIs, PI proxies, and primary contacts of all related studies. The RNI also appears in My Inbox for the responsible party.<\/p>\n<p>Visit <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/respond-to-hsd\/\">Respond to HSD<\/a> for detailed instructions for responding to a clarification request.<\/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: View the RNI details and IRB\u2019s required action plan<\/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><strong>Read the letter:<\/strong> Click the letter link near the top of the RNI workspace. The letter typically contains the IRB\u2019s required action plan and a summary of the IRB\u2019s decisions.<\/li>\n<li><strong>Review the action plan:<\/strong> Click the Action Plan tab and read the required action plan listed there, plus any history of the action plan that might be helpful.<\/li>\n<li><strong>Review the RNI submission details:<\/strong> If you aren\u2019t already familiar with the details of the RNI, read it by clicking <strong>View RNI<\/strong> on the left side.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31255 size-large\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Review-Action-Required.png\" alt=\"Screenshot of the RNI workspace with the action letter, view RNI, and action plan tab highlighted\" width=\"1024\" height=\"382\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Review-Action-Required.png 1240w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Review-Action-Required-300x112.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Review-Action-Required-768x287.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Review-Action-Required-1024x382.png 1024w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Review-Action-Required-375x140.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Review-Action-Required-750x280.png 750w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Review-Action-Required-1140x426.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: Take the actions required to complete the action plan<\/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 the action plan requires a change to a study, <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/modifications-to-uw-reviewed-studies\/\">create a modification and submit it for review<\/a>. If there is a related modification, you should also link it to the RNI using the <strong>Add Related Submission<\/strong> activity.<\/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: Responsible Party or an RNI Editor Must Submit Action Response<\/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 Action Response<\/strong> to indicate that the action plan is complete<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31257 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Submit-Action-Response.png\" alt=\"Screenshot of the Submit Action Response action in Zipline\" width=\"258\" height=\"275\" \/><\/p>\n<ul>\n<li>Add your written response in the notes field or as an attachment, including a summary of the actions taken to resolve the reported issue and complete the action plan and click OK<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-31251 size-full\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Complete-Submit-Action-Response.png\" alt=\"screenshot of the submit action response window\" width=\"730\" height=\"647\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Complete-Submit-Action-Response.png 730w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Complete-Submit-Action-Response-300x266.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/12\/Reports-of-New-Information-Homepage-Complete-Submit-Action-Response-375x332.png 375w\" sizes=\"auto, (max-width: 730px) 100vw, 730px\" \/><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Table of Contents Submit RNI Respond to Action Required Review Report Safety\/Compliance Information for an overview of reporting requirements and the RNI process. Submit RNI Respond&#8230;<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":9048,"menu_order":6,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-31245","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>Reports of New Information - 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\/reports-of-new-information\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Reports of New Information - UW Research\" \/>\n<meta property=\"og:description\" content=\"Table of Contents Submit RNI Respond to Action Required Review Report Safety\/Compliance Information for an overview of reporting requirements and the RNI process. 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