1.0Clinical Research Support Office (CRSO)/crsoCatherine Barnes/crso/author/cbracken/NEW SOP 1401 Promptly Reportable Information (NRP Listserv) - Clinical Research Support Office (CRSO)rich600338<blockquote class="wp-embedded-content" data-secret="gUTa4IJako"><a href="/crso/2021/10/new-sop-1401-promptly-reportable-information/">NEW SOP 1401 Promptly Reportable Information (NRP Listserv)</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="/crso/2021/10/new-sop-1401-promptly-reportable-information/embed/#?secret=gUTa4IJako" width="600" height="338" title="“NEW SOP 1401 Promptly Reportable Information (NRP Listserv)” — Clinical Research Support Office (CRSO)" data-secret="gUTa4IJako" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript"> /* <![CDATA[ */ /*! This file is auto-generated */ !function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document); /* ]]> */ </script> On October 1, 2021 the ºÚÁÏÍø-Chapel Hill OHRE released the newest version of SOP 1401 – Promptly Reportable Information. This replaces SOP 1401 – New Safety Information and is in effect as of October 1, 2021. This revision was done to align definitions across collaborating institutions, comply with FDA requirements and recent guidance, and enhance … Read more