{"id":1708,"date":"2026-10-06T12:48:53","date_gmt":"2026-10-06T12:48:53","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/e2a\/"},"modified":"2026-10-06T12:48:53","modified_gmt":"2026-10-06T12:48:53","slug":"e2a","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/e2a\/","title":{"rendered":"E2A \u2013 Clinical Safety Data Management: Definitions and Standards for Expedited Reporting"},"content":{"rendered":"<p>The ICH Harmonised Guideline was finalised under <em>Step 4<\/em> in October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Harmonised Guideline was finalised under Step 4 in October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[9],"guideline_tag":[],"rd_phase":[],"class_list":["post-1708","guideline","type-guideline","status-publish","hentry","guideline_category-efficacy"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1708","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\/1708\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1708"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1708"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1708"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1708"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}