{"id":1714,"date":"2026-10-06T12:48:55","date_gmt":"2026-10-06T12:48:55","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/e2f\/"},"modified":"2026-10-06T12:48:55","modified_gmt":"2026-10-06T12:48:55","slug":"e2f","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/e2f\/","title":{"rendered":"E2F \u2013 Development Safety Update Report"},"content":{"rendered":"<p>The ICH Harmonised Guideline was finalised under <em>Step 4<\/em> in August 2010. The Development Safety Update Report (DSUR) proposed in this Guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The main focus of the DSUR is data and findings from interventional clinical trials (referred to as &#8220;clinical trials&#8221;) of drugs and biologicals that are under investigation, whether or not they have a marketing approval.<\/p>\n<p>Following the completion of the E2F <em>Step 4 <\/em>Guideline, the E2F EWG developed DSUR Examples for commercial and non-commercial sponsors to help with the use of the E2F Guideline. It should be noted that these documents are only examples and therefore did not go through the Formal ICH Procedure.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Harmonised Guideline was finalised under Step 4 in August 2010. The Development Safety Update Report (DSUR) proposed in this Guideline is intended to be a common standard for periodic reporting on drugs under\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[9],"guideline_tag":[],"rd_phase":[],"class_list":["post-1714","guideline","type-guideline","status-publish","hentry","guideline_category-efficacy"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1714","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1714\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1714"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1714"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1714"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1714"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}