{"id":774,"date":"2018-05-08T10:32:39","date_gmt":"2018-05-08T10:32:39","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/external-adverse-event-ae-reporting\/"},"modified":"2026-03-04T17:18:35","modified_gmt":"2026-03-04T22:18:35","slug":"external-adverse-event-ae-reporting","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/external-adverse-event-ae-reporting\/","title":{"rendered":"External Adverse Event (AE) Reporting"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[76,42,43,66],"update-type":[],"class_list":["post-774","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-adverse-events-other-reportable-information-and-occurrences","topic-application-types","topic-eresearch-regulatory-management-errm","topic-investigator-study-team-responsibilities"],"acf":{"use_legacy_editor":true,"updated_date":"2015-08-14 12:30:00","update_notice":false,"author":"IRBMED","summary":"This page explains the required reporting for 'external' AEs. These are events that are under the direct oversight of\u00a0<strong>non<\/strong>-UM <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigators<\/a> and\u00a0<strong>non<\/strong>-UM <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-irb\">IRBs<\/a>, events about which the UM investigator receives a report, usually from the study <a class=\"gtip\" href=\"\/medschool\/glossary\/sponsor\">sponsor<\/a> or oversight entity.\r\n<ul>\r\n \t<li>The UM investigator is<strong>\u00a0required<\/strong>\u00a0to submit the report to the IRB only when one of following criteria applies:<\/li>\r\n \t<li>The event or information in the report constitutes an <a class=\"gtip\" href=\"\/medschool\/glossary\/unanticipated-problem-involving-risks-subjects-or-others-upirso-uap\">'unanticipated problem'<\/a>*<\/li>\r\n \t<li>The report requires a change in the <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a><\/li>\r\n<\/ul>\r\nThe report is an analysis, safety, or statistical report from an oversight entity (e.g. <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> letter, Periodic Sponsor Report of all AEs, <a class=\"gtip\" href=\"\/medschool\/glossary\/data-and-safety-monitor\">Data and Safety Monitoring Board<\/a> Report)\r\n\r\nThe information below explains the time frames for reporting and which forms should be used (based on the nature of the report).","button_links":null,"related_content":[865,732,863,862],"legacy_path":"external-adverse-event-ae-reporting","legacy_node_id":316,"legacy_related_nids":"925, 261, 522, 521","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"*Unanticipated Problems Involving Risks to Subjects or Others\u2014Assessment Criteria","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ol>\r\n \t<li>The nature, severity, or frequency of the event(s) or information was\u00a0<strong>NOT<\/strong>\u00a0expected, given descriptions in the study documents or the\u00a0characteristics of the subject population\u00a0being studied.<\/li>\r\n \t<li>There is a reasonable possibility that the procedures involved in the <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> caused or are linked in a significant way to the problem.<\/li>\r\n \t<li>The event(s) or information suggests that the research places subjects or others at a\u00a0<strong>greater risk<\/strong>\u00a0of harm\u00a0<strong>than was previously known or recognized\u00a0<\/strong>(including physical, psychological, economic, or social harm).<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Instructions for Reporting External Adverse Events to the IRB","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<a href=\"\/medschool\/guidance\/unanticipated-problems-involving-risks-subjects-or-others\">Follow this for more information about making an 'unanticipated problem' assessment<\/a>\r\n<table style=\"width: 84.7157%;height: 2408px\" border=\"1\" cellspacing=\"1\" cellpadding=\"1\">\r\n<tbody>\r\n<tr style=\"height: 102px\">\r\n<td style=\"text-align: center;width: 149.304%;height: 102px\" colspan=\"3\">Instructions for Reporting <a class=\"gtip\" href=\"\/medschool\/glossary\/external-adverse-event\">External Adverse Events<\/a> to the <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-irb\">IRB<\/a>\r\n\r\n<strong>All reference to 'days' herein refers to 'calendar days' rather than 'working days.'<\/strong><\/td>\r\n<\/tr>\r\n<tr style=\"height: 25px\">\r\n<td style=\"text-align: center;width: 42.3459%;height: 25px\"><strong>Report Type<\/strong><\/td>\r\n<td style=\"text-align: center;width: 28.4294%;height: 25px\"><strong>Required Timeframe<\/strong><\/td>\r\n<td style=\"text-align: center;width: 78.5288%;height: 25px\"><strong>Required Information<\/strong><\/td>\r\n<\/tr>\r\n<tr style=\"height: 459px\">\r\n<td style=\"width: 42.3459%;height: 459px\"><a href=\"\/medschool\/guidance\/unanticipated-problems-involving-risks-subjects-or-others\">Unanticipated Problem Involving Risks to Subjects or Others<\/a>:\u00a0A report of any harm or an analysis of drug or study AE trends that suggests the <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> places subjects or others at a greater risk of harm than was previously known or recognized and\/or is significant to the rights and welfare of <a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">human subjects<\/a> in the study.\r\n\r\nThe judgment that an event, series of events, or analysis is an 'unanticipated problem' may be made by the sponsor, <a class=\"gtip\" href=\"\/medschool\/glossary\/data-and-safety-monitoring-board-dsmb\">DSMB<\/a>\/<a class=\"gtip\" href=\"\/medschool\/glossary\/dsc\">DSC<\/a>, other oversight entity, or the UM <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigator.<\/a><\/td>\r\n<td style=\"width: 28.4294%;height: 459px\">Within\u00a0<a class=\"GTIP\" href=\"\/medschool\/glossary\/7-calendar-days\">7 days<\/a>\u00a0of receipt of the report if\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/serious\"><em><strong>serious<\/strong><\/em><\/a><em><strong>\u00a0<\/strong><\/em>and <a class=\"gtip\" href=\"\/medschool\/glossary\/relatedness-adverse-events\">related<\/a>\r\nWithin\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/14-calendar-days\">14 days<\/a>\u00a0of receipt of the report if<em>\u00a0<strong>non-<\/strong>serious<\/em><strong>\u00a0<\/strong>and <a class=\"gtip\" href=\"\/medschool\/glossary\/relatedness-adverse-events\">related<\/a><\/td>\r\n<td style=\"width: 78.5288%;height: 459px\">1. The phrase <a class=\"gtip\" href=\"\/medschool\/glossary\/unanticipated-problem-involving-risks-subjects-or-others-upirso-uap\">'Unanticipated Problem'<\/a> or the acronym 'UaP' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].\r\n\r\n2. An explanation of how the event is <a class=\"gtip\" href=\"\/medschool\/glossary\/unanticipated\">unanticipated<\/a>.\r\n\r\n3. An explanation of how the event is\u00a0a\u00a0problem\u00a0<em>for the study.<\/em>\r\n\r\n4. A copy of the report from the external source.<\/td>\r\n<\/tr>\r\n<tr style=\"height: 306px\">\r\n<td style=\"width: 42.3459%;height: 306px\"><strong>Unanticipated Adverse Device Effect\u00a0<\/strong>(UADE:) Reports from sponsors of any serious adverse effect on the health or safety of subjects, or any life-threatening problem or <a class=\"gtip\" href=\"\/medschool\/glossary\/death\">death<\/a> caused by, or associated with, a device, if that problem or death was not previously identified in nature, severity, or degree of incidence in the investigational plan (<a class=\"gtip\" href=\"\/medschool\/glossary\/21-cfr%E2%80%A6\">21 CFR<\/a> 812).<\/td>\r\n<td style=\"width: 28.4294%;height: 306px\">Within\u00a07 days\u00a0of receipt of the report<\/td>\r\n<td style=\"width: 78.5288%;height: 306px\">1. The phrase 'Unanticipated Adverse Device Effect' or the acronym 'UADE' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].\r\n\r\n2. A copy of the sponsor's report.<\/td>\r\n<\/tr>\r\n<tr style=\"height: 357px\">\r\n<td style=\"width: 42.3459%;height: 357px\"><strong>Medwatch or other Report of a Single Adverse Event<\/strong>\u00a0that is\u00a0not\u00a0judged an 'unanticipated problem' (see above) but\u00a0<strong>requires a change<\/strong>\u00a0in the research (e.g. the <a class=\"gtip\" href=\"\/medschool\/glossary\/protocol\">protocol<\/a>, consent, risk level, investigator's brochure).<\/td>\r\n<td style=\"width: 28.4294%;height: 357px\"><strong>PI initiated study:<\/strong>\u00a0Within 7 days of notification of the event\r\n\r\n<strong>Sponsored or Cooperative-group Study<\/strong>:\u00a0Within 7 days of notification of the requirement for the change<\/td>\r\n<td style=\"width: 78.5288%;height: 357px\">1. Justification for why the event necessitates the change(s).\r\n\r\n2. Notification of any changes made prior to IRB approval to eliminate apparent immediate hazards to subject(s) or others.\r\n\r\n3. A copy of the report from the external source.<\/td>\r\n<\/tr>\r\n<tr style=\"height: 229px\">\r\n<td style=\"width: 42.3459%;height: 229px\"><strong>DSMB\/DSC Report<\/strong>\u00a0(may include external and <a class=\"gtip\" href=\"\/medschool\/glossary\/um-event\">UM events<\/a>)<\/td>\r\n<td style=\"width: 28.4294%;height: 229px\">Within\u00a0<strong>7 days<\/strong>\u00a0of receipt if a change to the research is required\u00a0<strong>OR<\/strong>\u00a0the <a class=\"gtip\" href=\"\/medschool\/glossary\/risk-benefit-ratio\">risk\/ benefit ratio<\/a>\u00a0of the study or subjects' willingness to participate is affected.\r\n\r\n<strong>Otherwise at <a class=\"gtip\" href=\"\/medschool\/glossary\/scheduled-continuing-review-scr\">SCR<\/a><\/strong><\/td>\r\n<td style=\"width: 78.5288%;height: 229px\">1. Investigator's response.\r\n\r\n2. A copy of the report from the external source.<\/td>\r\n<\/tr>\r\n<tr style=\"height: 229px\">\r\n<td style=\"width: 42.3459%;height: 229px\"><strong>Periodic Summaries or Analyses<\/strong>\u00a0of study-wide adverse events<\/td>\r\n<td style=\"width: 28.4294%;height: 229px\">Within\u00a0<strong>7 days<\/strong>\u00a0of receipt if a change to the research is required\u00a0<strong>OR<\/strong>\u00a0the risk\/ benefit ratio of the study or subjects' willingness to participate is affected.\r\n\r\n<strong>Otherwise at SCR<\/strong><\/td>\r\n<td style=\"width: 78.5288%;height: 229px\">1. Investigator's response.\r\n\r\n2. A copy of the report.<\/td>\r\n<\/tr>\r\n<tr style=\"height: 246px\">\r\n<td style=\"width: 42.3459%;height: 246px\"><strong>Medwatch or other Report of a Single** Adverse Even<\/strong>t\u00a0where\u00a0<strong>both<\/strong>\u00a0of the following are true:\r\n<ul>\r\n \t<li>Event is\u00a0<strong>not<\/strong>\u00a0deemed an unanticipated problem<\/li>\r\n \t<li>Event does\u00a0<strong>not\u00a0<\/strong>require a change in the research (e.g. the protocol, consent, investigator's brochure).<\/li>\r\n<\/ul>\r\n<\/td>\r\n<td style=\"width: 28.4294%;height: 246px\"><strong>An IRB submission is not required<\/strong>\u00a0but may be accepted with the investigator's justification for submitting the report<\/td>\r\n<td style=\"width: 78.5288%;height: 246px\">1. Investigator's justification or reasons for submitting a report that is not required.\r\n\r\n2. A copy of the report<\/td>\r\n<\/tr>\r\n<tr style=\"height: 445px\">\r\n<td style=\"width: 42.3459%;height: 445px\"><strong>Follow-up Report on a Single Adverse Event deemed an unanticipated problem\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/strong>\r\n<ul>\r\n \t<li>Unanticipated problem judgment may have been made with the initial report or may be a new assessment based upon new information<\/li>\r\n<\/ul>\r\n<\/td>\r\n<td style=\"width: 28.4294%;height: 445px\">Within\u00a07 days\u00a0of receipt of the report if\u00a0<em><strong>serious\u00a0<\/strong><\/em>and related\r\nWithin\u00a014 days\u00a0of receipt of the report if<em>\u00a0<strong>non-<\/strong>serious<\/em><strong>\u00a0<\/strong>and related<\/td>\r\n<td style=\"width: 78.5288%;height: 445px\">1. The phrase 'Unanticipated Problem' or the acronym 'UaP' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].\r\n\r\n2. An explanation of how the event is <a class=\"gtip\" href=\"\/medschool\/glossary\/unanticipated\">unanticipated<\/a> noting if this assessment is new, and if so, why.\r\n\r\n3. An explanation of how the event is\u00a0a\u00a0problem\u00a0for the study.\r\n\r\n4. A copy of the report from the external source<\/td>\r\n<\/tr>\r\n<tr style=\"height: 10px\">\r\n<td style=\"width: 42.3459%;height: 10px\"><strong><a class=\"gtip\" href=\"\/medschool\/glossary\/follow\">Follow-up<\/a> Report on a Single Adverse Event not deemed an unanticipated problem<\/strong><\/td>\r\n<td style=\"width: 28.4294%;height: 10px\"><strong>An IRB submission is not required\u00a0<\/strong>but may be accepted with the investigator's justification for submitting the report<\/td>\r\n<td style=\"width: 78.5288%;height: 10px\">1. Investigator's justification or reasons for submitting a report that is not required.\r\n\r\n2. A copy of the report<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n** Sometimes a sponsor will send multiple 'single' AE reports to an investigator in a batch. These are still considered the type of reports for which a submission to the IRB is not required (unless there is a UaP or a change is required to the research as noted above). What distinguishes a batch of 'single' AEs from the DSMB and\/or periodic analyses that\u00a0must\u00a0be submitted to the IRB is that the latter include some level of analysis, judgment, or relevant summary that puts the events in a context that provides meaningful information about the study. Examples include but are not limited to the number of AEs in relation to the number of subjects, AEs in relation to the 'n' of the study, an identified series of AEs that indicates a trend.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[],"update_notice_start":"","update_notice_end":"","update_notice_text_blocks":null,"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\n<p>A <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.<\/p>\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: March 4, 2026 5:15PM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/774","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":1,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/774\/revisions"}],"predecessor-version":[{"id":1901,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/774\/revisions\/1901"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/862"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/863"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/732"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/865"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=774"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=774"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=774"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=774"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=774"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=774"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}