{"id":541,"date":"2018-05-30T11:13:33","date_gmt":"2018-05-30T11:13:33","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/glossary\/medschool-glossary-unexpected-adverse-event\/"},"modified":"2024-12-04T21:52:11","modified_gmt":"2024-12-04T21:52:11","slug":"unexpected-adverse-event","status":"publish","type":"glossary","link":"https:\/\/az.research.umich.edu\/medschool\/glossary\/unexpected-adverse-event\/","title":{"rendered":"Unexpected Adverse Event"},"template":"","class_list":["post-541","glossary","type-glossary","status-publish","hentry"],"acf":{"glossary_term_description":"Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is\u00a0<em><strong>not\u00a0<\/strong><\/em>consistent with either:\r\n<ol>\r\n \t<li>The known or foreseeable risk of AEs associated with the procedures involved in the research that are described in (a) the IRB-approved documents (e.g., applicable investigator brochure, current protocol narrative, current informed consent document), and (b) other relevant sources of information, such as product labeling and package inserts; or<\/li>\r\n \t<li>The expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the AE and the subject\u2019s predisposing risk factor profile for the AE.<\/li>\r\n<\/ol>","glossary_related_terms":"","legacy_glossary_node_id":782,"legacy_related_terms":""},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary\/541","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/glossary"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=541"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}