{"id":732,"date":"2018-05-02T11:09:13","date_gmt":"2018-05-02T11:09:13","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/adverse-event-reporting\/"},"modified":"2026-02-23T11:15:17","modified_gmt":"2026-02-23T16:15:17","slug":"adverse-event-reporting","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/adverse-event-reporting\/","title":{"rendered":"Adverse Event Reporting"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[76,42,43,66],"update-type":[],"class_list":["post-732","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":"2018-06-11 08:00:00","update_notice":false,"author":"IRBMED","summary":"Internal <a class=\"gtip\" href=\"\/medschool\/glossary\/adverse-event-ae\">adverse events<\/a> are events that involve subjects or others whom the U-M <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigator<\/a> is responsible for and\/or events for which a UM IRB has direct oversight.\r\n\r\nThese guidelines apply\u00a0only to IRBMED reporting. They do not apply to required reporting to other internal or external oversight agencies or departments (e.g., <a class=\"gtip\" href=\"\/medschool\/glossary\/sponsor\">sponsor<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a>, UMHS Compliance Office, <a class=\"gtip\" href=\"\/medschool\/glossary\/data-and-safety-monitoring-board-dsmb\">DSMB<\/a>, or Privacy Offices).\r\n\r\n<em>For information about other types of required reporting, see the\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/adverse-events-aes-other-reportable-information-and-occurrences-orios-other\">Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting<\/a>\u00a0page.<\/em>","button_links":null,"related_content":[863,774,865,862],"legacy_path":"adverse-event-reporting","legacy_node_id":261,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Reporting timetable for approved studies subject to annual Continuing Review (CR)","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 class=\"gtip\" href=\"\/medschool\/glossary\/continuing-review-cr\">\u201cContinuing Review\u201d (CR)<\/a> consists of annual submission by study team of a report on the study\u2019s status and continued plans, for renewed review and approval by the IRB. See <a href=\"https:\/\/research.medicine.umich.edu\/our-units\/institutional-review-boards-irbmed\/frequently-asked-questions-faq\">IRBMED FAQ<\/a> heading \u201cOngoing Review.\u201d <strong>If an approved study space shows an Expiration Date, the study requires CR. <\/strong>\r\n\r\nThis chart is for studies requiring annual Continuing Review that follow IRBMED standard AE reporting. It may be appropriate for some studies to consider a\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/study-specific-adverse-event-ae-reporting-plans\">Study-Specific AE Reporting Plan<\/a>. See the gray boxes below for information about External AE and UaP reporting.","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":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-full","legacy_media_file":908,"legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":[{"legacy_button":{"title":"PDF version of this table","url":"\/medschool\/wp-content\/uploads\/sites\/3\/2025\/07\/res_irbmed_Adverse-Event-Reporting-Guidelines-for-INTERNAL-AEs-Occurring-at-UM.pdf","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"media","legacy_heading":"","legacy_subheading":"Definitions","legacy_section_text":"<a class=\"gtip\" href=\"\/medschool\/glossary\/scheduled-continuing-review-scr\"><strong>SCR<\/strong>: Scheduled Continuing Review<\/a>;\u00a0<strong>Expected<\/strong>: Has been addressed in one or more of following: <a class=\"gtip\" href=\"\/medschool\/glossary\/protocol\">Protocol<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/investigators-brochure-ib\/\">Investigator Brochure<\/a>, Package Insert or equivalent, published literature, IRB application, grant application, Data Safety Monitoring Board\/Data Safety Committee reports, other documentation, <a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent-document-icd-or-informed-consent-form-icf\">informed consent document (ICD)<\/a> or characteristics of the study population. Note, per\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/reviewing-unanticipated-problems\/index.html#Q3\">OHRP guidance<\/a>, event may be \u201cexpected\u201d per the natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event;\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/unexpected\"><strong>Unexpected<\/strong><\/a>:\u00a0Has not been addressed in one or more of the above examples;\u00a0<strong>Related<\/strong>:\u00a0See below;\u00a0<strong>Unrelated<\/strong>:\u00a0See Below","legacy_media_position":"media-full","legacy_media_file":908,"legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Definitions","legacy_section_text":"<a class=\"gtip\" href=\"\/medschool\/glossary\/scheduled-continuing-review-scr\"><strong>SCR<\/strong>: Scheduled Continuing Review<\/a>;\u00a0<strong>Expected<\/strong>: Has been addressed in one or more of following: <a class=\"gtip\" href=\"\/medschool\/glossary\/protocol\">Protocol<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/investigators-brochure-ib\/\">Investigator Brochure<\/a>, Package Insert or equivalent, published literature, IRB application, grant application, Data Safety Monitoring Board\/Data Safety Committee reports, other documentation, <a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent-document-icd-or-informed-consent-form-icf\">informed consent document (ICD)<\/a> or characteristics of the study population. Note, per\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/reviewing-unanticipated-problems\/index.html#Q3\">OHRP guidance<\/a>, event may be \u201cexpected\u201d per the natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event;\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/unexpected\"><strong>Unexpected<\/strong><\/a>:\u00a0Has not been addressed in one or more of the above examples;\u00a0<strong>Related<\/strong>:\u00a0See below;\u00a0<strong>Unrelated<\/strong>:\u00a0See Below","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_with_subheading","legacy_heading":"","legacy_subheading":"References","legacy_section_text":"<ul>\r\n \t<li><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-312.32\">21 CFR 312.32<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/adverse-event-reporting-irbs-improving-human-subject-protection\">Adverse Event Reporting to IRBs<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/reviewing-unanticipated-problems\/index.html#Q3\">OHRP-Which AEs are UaPs?<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/reviewing-unanticipated-problems\/index.html\">OHRP\u2014Guidance on Reviewing and Reporting UaPs and AEs<\/a><\/li>\r\n \t<li><a href=\"https:\/\/ctep.cancer.gov\/protocoldevelopment\/electronic_applications\/ctc.htm\">Common Terminology Criteria for Adverse Events (CTCAE) - Oncology studies Grade System<\/a><\/li>\r\n<\/ul>","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_with_subheading","legacy_heading":"Studies NOT requiring Continuing Review (CR)","legacy_subheading":"Defining Relationship to Study Drug\/Device\/Procedure","legacy_section_text":"The IRB recognizes that it can be difficult to determine the relationship of event or events to a specific drug\/device\/procedure when there are several contributing factors.\u00a0Events should be rated according to the following parameters:","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":"Studies NOT requiring Continuing Review (CR)","legacy_subheading":"","legacy_section_text":"Per <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/revision-of-the-common-rule\/index.html\">2018 Revised Common Rule<\/a>, some ongoing studies <strong>no longer <\/strong>\u00a0require annual <a class=\"gtip\" href=\"\/medschool\/glossary\/continuing-review-cr\">Continuing Review (CR)<\/a>. <strong>The study workspace indicates \u201cNo Continuing Review Required for this application\u201d when applicable. <\/strong>Studies not requiring CR should report <strong>only<\/strong> potential <a class=\"gtip\" href=\"\/medschool\/glossary\/unanticipated-problem-involving-risks-subjects-or-others-upirso-uap\">Unanticipated Problems (UaPs or UPIRSOs)<\/a> that come to the attention of the study team. Routine AEs need not be reported. This also applies to studies that previously had an approved Study-specific AE reporting plan.\r\n\r\nUnanticipated Problems meet <strong>all of the following criteria<\/strong>:\r\n<ol>\r\n \t<li><strong><a class=\"gtip\" href=\"\/medschool\/glossary\/unexpected\">Unexpected<\/a> <\/strong>(in terms of nature, <a class=\"gtip\" href=\"\/medschool\/glossary\/severity\">severity<\/a>, or frequency);<\/li>\r\n \t<li><strong>Related or possibly related to participation in the <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a><\/strong>; and<\/li>\r\n \t<li>Suggests that the research places subjects or others at <strong>a greater <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk<\/a> of harm<\/strong> than was previously known or recognized.<\/li>\r\n<\/ol>\r\nSee the <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/unanticipated-problems-involving-risks-subjects-or-others\">Unanticipated Problems Involving Risks to Subjects or Others<\/a> page and <a href=\"http:\/\/research-compliance.umich.edu\/operations-manual-quality-assurance-and-research-compliance\">U-M HRPP Operations Manual Part 12<\/a>.III.B.1.a for more details.","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":"Events Related","legacy_subheading":"","legacy_section_text":"Per <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/revision-of-the-common-rule\/index.html\">2018 Revised Common Rule<\/a>, some ongoing studies <strong>no longer <\/strong>\u00a0require annual <a class=\"gtip\" href=\"\/medschool\/glossary\/continuing-review-cr\">Continuing Review (CR)<\/a>. <strong>The study workspace indicates \u201cNo Continuing Review Required for this application\u201d when applicable. <\/strong>Studies not requiring CR should report <strong>only<\/strong> potential <a class=\"gtip\" href=\"\/medschool\/glossary\/unanticipated-problem-involving-risks-subjects-or-others-upirso-uap\">Unanticipated Problems (UaPs or UPIRSOs)<\/a> that come to the attention of the study team. Routine AEs need not be reported. This also applies to studies that previously had an approved Study-specific AE reporting plan.\r\n\r\nUnanticipated Problems meet <strong>all of the following criteria<\/strong>:\r\n<ol>\r\n \t<li><strong><a class=\"gtip\" href=\"\/medschool\/glossary\/unexpected\">Unexpected<\/a> <\/strong>(in terms of nature, <a class=\"gtip\" href=\"\/medschool\/glossary\/severity\">severity<\/a>, or frequency);<\/li>\r\n \t<li><strong>Related or possibly related to participation in the <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a><\/strong>; and<\/li>\r\n \t<li>Suggests that the research places subjects or others at <strong>a greater <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk<\/a> of harm<\/strong> than was previously known or recognized.<\/li>\r\n<\/ol>\r\nSee the <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/unanticipated-problems-involving-risks-subjects-or-others\">Unanticipated Problems Involving Risks to Subjects or Others<\/a> page and <a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">U-M HRPP Operations Manual<\/a> Part 12.II.B for more details.","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":"Events Related","legacy_subheading":"Definitely Related","legacy_section_text":"<ul>\r\n \t<li>The event is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including <a class=\"gtip\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/investigators-brochure-ib\/\">IB<\/a>, consent, publications)<\/li>\r\n \t<li>The event follows an obvious sequence of time, from the drug\u2019s administration, device\u2019s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure.<\/li>\r\n \t<li>The event ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting).<\/li>\r\n \t<li>The event includes data that was only collected for the study.<\/li>\r\n \t<li>The event included disturbing or upsetting questions that the subject was asked for the purpose of the\r\nresearch.<\/li>\r\n<\/ul>","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_with_subheading","legacy_heading":"","legacy_subheading":"Definitely Related","legacy_section_text":"<ul>\r\n \t<li>The event is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including <a class=\"gtip\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/investigators-brochure-ib\/\">IB<\/a>, consent, publications)<\/li>\r\n \t<li>The event follows an obvious sequence of time, from the drug\u2019s administration, device\u2019s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure.<\/li>\r\n \t<li>The event ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting).<\/li>\r\n \t<li>The event includes data that was only collected for the study.<\/li>\r\n \t<li>The event included disturbing or upsetting questions that the subject was asked for the purpose of the\r\nresearch.<\/li>\r\n<\/ul>","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_with_subheading","legacy_heading":"","legacy_subheading":"Probably Related","legacy_section_text":"<ul>\r\n \t<li>The event is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)<\/li>\r\n \t<li>The event follows a reasonable sequence of time from the drug\u2019s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.<\/li>\r\n \t<li>The event ceases or diminishes with discontinuation of the drug, removal\/discontinued activation of the device, or procedure.<\/li>\r\n<\/ul>","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_with_subheading","legacy_heading":"Events Not Related","legacy_subheading":"Possibly Related","legacy_section_text":"<ul>\r\n \t<li>The event is a lesser known or possible effect of the drug, device, or procedure.<\/li>\r\n \t<li>The event occurred within a sequence of time from the drug\u2019s administration, device implantation and\/or activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.<\/li>\r\n \t<li>The event could be explained by the characteristics of the population under study.<\/li>\r\n<\/ul>","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":"Events Not Related","legacy_subheading":"Unlikely Related","legacy_section_text":"<ul>\r\n \t<li>The event is NOT a previously known or suspected effect of the test drug, device, or procedure.<\/li>\r\n \t<li>The event does NOT follow a sequence of time# from drug administration, device implantation and\/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.<\/li>\r\n \t<li>The event can be readily explained by the characteristics of the population under study.<\/li>\r\n<\/ul>","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_with_subheading","legacy_heading":"","legacy_subheading":"Unlikely Related","legacy_section_text":"<ul>\r\n \t<li>The event is NOT a previously known or suspected effect of the test drug, device, or procedure.<\/li>\r\n \t<li>The event does NOT follow a sequence of time# from drug administration, device implantation and\/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.<\/li>\r\n \t<li>The event can be readily explained by the characteristics of the population under study.<\/li>\r\n<\/ul>","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_with_subheading","legacy_heading":"Other Reporting Tables","legacy_subheading":"Unrelated","legacy_section_text":"<ul>\r\n \t<li>The event is NOT known to be an effect of the test drug, device, or procedure.<\/li>\r\n \t<li>The event does NOT follow a sequence of time from drug administration, device implantation and\/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.<\/li>\r\n \t<li>The event can be readily and easily explained by the characteristics of the population under study.<\/li>\r\n \t<li>Subject never received <a class=\"gtip\" href=\"\/medschool\/glossary\/study-drug\">study drug<\/a>, study device, or underwent research study procedure.<\/li>\r\n<\/ul>\r\nStep-by-step instructions (below) for applying these guidelines appear below.","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":"Other Reporting Tables","legacy_subheading":"","legacy_section_text":"<ul>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/study-specific-ae-reporting\">Study-Specific Adverse Event (AE) Reporting<\/a>\r\n<ul>\r\n \t<li>Encouraged for minimal- to moderate-<a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk<\/a> studies that are not under <a class=\"gtip\" href=\"\/medschool\/glossary\/fda-oversight\">FDA oversight<\/a>; many <a class=\"gtip\" href=\"\/medschool\/glossary\/sponsor\">sponsor<\/a>ed studies include an AE reporting plan.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/external-adverse-event-ae-reporting\">External\/Non-UM AE Reporting<\/a><\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/humanitarian-use-device-requirements-u-m-physicians-investigators\">Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE)<\/a><\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/other-reportable-information-or-occurrence-orio\">Other Reportable Information and Occurrences (ORIO)<\/a>\r\n<ul>\r\n \t<li>Events that are not adverse events (no harm occurred) or reports to or from and oversight bodies<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","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":"Reporting Procedures","legacy_subheading":"","legacy_section_text":"<ul>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/study-specific-ae-reporting\">Study-Specific Adverse Event (AE) Reporting<\/a>\r\n<ul>\r\n \t<li>Encouraged for minimal- to moderate-<a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk<\/a> studies that are not under <a class=\"gtip\" href=\"\/medschool\/glossary\/fda-oversight\">FDA oversight<\/a>; many <a class=\"gtip\" href=\"\/medschool\/glossary\/sponsor\">sponsor<\/a>ed studies include an AE reporting plan.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/external-adverse-event-ae-reporting\">External\/Non-UM AE Reporting<\/a><\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/humanitarian-use-device-requirements-u-m-physicians-investigators\">Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE)<\/a><\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/other-reportable-information-or-occurrence-orio\">Other Reportable Information and Occurrences (ORIO)<\/a>\r\n<ul>\r\n \t<li>Events that are not adverse events (no harm occurred) or reports to or from and oversight bodies<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","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":"Reporting Procedures","legacy_subheading":"For studies in eResearch (IRB web-based application system):","legacy_section_text":"Open the <a class=\"gtip\" href=\"\/medschool\/glossary\/approved-decision\">approved<\/a> study in\u00a0<a href=\"http:\/\/www.eresearch.umich.edu\">eResearch<\/a>. Click on <a class=\"gtip\" href=\"\/medschool\/glossary\/adverse-event-ae\">AE<\/a>\/<a class=\"gtip\" href=\"\/medschool\/glossary\/other-reportable-information-or-occurrence-orio\">ORIO<\/a>\u00a0<em>function tab<\/em>\u00a0in the left column\u00a0(which looks like the screen shot shown to the here).\r\n<ul>\r\n \t<li>Instructions for submitting an AE are\u00a0<a href=\"https:\/\/documentation.its.umich.edu\/node\/1327\">available here<\/a>.<\/li>\r\n \t<li>If the event necessitates an amendment to the protocol or <a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent-document-icd-or-informed-consent-form-icf\">informed consent document<\/a>, you must submit an amendment after submitting the AE. If the AE obliges the investigator to inform previously enrolled subjects, include in the amendment the mechanism by which this will be done.\r\n<ul>\r\n \t<li>For example, sending a letter to all previously enrolled subjects, upload the letter in the amendment submission.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","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_with_subheading","legacy_heading":"","legacy_subheading":"For studies in eResearch (IRB web-based application system):","legacy_section_text":"Open the <a class=\"gtip\" href=\"\/medschool\/glossary\/approved-decision\">approved<\/a> study in\u00a0<a href=\"http:\/\/www.eresearch.umich.edu\">eResearch<\/a>. Click on <a class=\"gtip\" href=\"\/medschool\/glossary\/adverse-event-ae\">AE<\/a>\/<a class=\"gtip\" href=\"\/medschool\/glossary\/other-reportable-information-or-occurrence-orio\">ORIO<\/a>\u00a0<em>function tab<\/em>\u00a0in the left column\u00a0(which looks like the screen shot shown to the here).\r\n<ul>\r\n \t<li>Instructions for submitting an AE are\u00a0<a href=\"https:\/\/documentation.its.umich.edu\/node\/1327\">available here<\/a>.<\/li>\r\n \t<li>If the event necessitates an amendment to the protocol or <a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent-document-icd-or-informed-consent-form-icf\">informed consent document<\/a>, you must submit an amendment after submitting the AE. If the AE obliges the investigator to inform previously enrolled subjects, include in the amendment the mechanism by which this will be done.\r\n<ul>\r\n \t<li>For example, sending a letter to all previously enrolled subjects, upload the letter in the amendment submission.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","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_with_subheading","legacy_heading":"","legacy_subheading":"Follow these steps if you are reporting a U-M Event","legacy_section_text":"<table style=\"width: 500px\" border=\"1\" cellspacing=\"1\" cellpadding=\"3\">\r\n<tbody>\r\n<tr>\r\n<td style=\"width: 95px\"><strong>Review Step 1<\/strong><\/td>\r\n<td style=\"width: 391px\" colspan=\"2\">The principal investigator should assess each adverse event by the following criteria. Note the answers, then refer to the timetable to determine the deadline by which the report should be submitted to the IRB.<\/td>\r\n<\/tr>\r\n<tr>\r\n<td style=\"width: 95px\" rowspan=\"2\"><strong>Step 2<\/strong><\/td>\r\n<td style=\"width: 391px\" colspan=\"2\">Do the IRB approved documents for this study include a detailed plan with a specific timetable or time schedule for AE reporting? (eResearch studies, see approved application section 32-1)<\/td>\r\n<\/tr>\r\n<tr>\r\n<td style=\"width: 391px\"><strong>YES<\/strong>:\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/study-specific-ae-reporting\">Use the Study Specific AE Reporting Timetable<\/a><\/td>\r\n<td style=\"width: 391px\"><strong>NO<\/strong>:\u00a0Continue below to Step 3<\/td>\r\n<\/tr>\r\n<tr>\r\n<td style=\"width: 95px\" rowspan=\"2\"><strong>Step 3<\/strong><\/td>\r\n<td style=\"width: 391px\" colspan=\"2\">Is the\u00a0AE to be reported\u00a0addressed or described in one or more of the following?\r\n<ul>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent-document-icd-or-informed-consent-form-icf\">Informed consent document(s)<\/a> for this study<\/li>\r\n \t<li>IRB application for this study (IRB only, not applicable to <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)<\/li>\r\n \t<li>Grant application or study agreement (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)<\/li>\r\n \t<li>Protocol or procedures for this study<\/li>\r\n \t<li>Investigators' brochure or equivalent (for FDA regulated drugs or devices)<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/data-and-safety-monitoring-board-dsmb\">DSMB<\/a>\/<a class=\"gtip\" href=\"\/medschool\/glossary\/dsc\">DSC<\/a> Reports (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)<\/li>\r\n \t<li>Published literature (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)<\/li>\r\n \t<li>Characteristics of the study population\u00a0(<strong>IRB only<\/strong>, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)<\/li>\r\n \t<li>Other (if documentation has not been submitted to the IRB previously it should be included in the AE submission) (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)<\/li>\r\n<\/ul>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td style=\"width: 391px\"><strong>YES<\/strong>\u00a0the\u00a0<em>AE<\/em> to be reported\u00a0is\u00a0<strong>EXPECTED<\/strong><\/td>\r\n<td style=\"width: 391px\"><strong>NO<\/strong> the\u00a0<em>AE<\/em> to be reported\u00a0is\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/unexpected\"><strong>UNEXPECTED<\/strong><\/a><\/td>\r\n<\/tr>\r\n<tr>\r\n<td style=\"width: 95px\"><strong>Step 4<\/strong><\/td>\r\n<td style=\"width: 391px\" colspan=\"2\">Determine the association of the\u00a0<em>AE to be reported<\/em>\u00a0with the\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/test-article\">test article<\/a>\u00a0or\u00a0test procedure\u00a0(the\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/part-46#p-46.102(e)(3)\">interaction<\/a>\u00a0or\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/part-46#p-46.102(e)(2)\">intervention<\/a>):\r\n<ul>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/definitely-related-adverse-event\">definitely related<\/a> (see above)<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/probably-related-adverse-event\">probably related<\/a> (see above)<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/possibly-related-adverse-event\">possibly related <\/a>(see above)<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/unlikely-related-adverse-event\">unlikely to be related<\/a> (see above)<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/unrelated-adverse-event\">definitely not related<\/a> (unrelated) (see above)<\/li>\r\n<\/ul>\r\n<a class=\"gtip\" href=\"\/medschool\/glossary\/relatedness-adverse-events\">RELATEDNESS<\/a> refers to the\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/cause\">cause<\/a>\u00a0of the adverse event. Investigators should assess whether the event is attributable, in whole or in part, to the study intervention\/agent.\r\n\r\nIf the investigator judges the event as being PROBABLY related to a\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/concurrent-standard-therapy\">concurrent standard therapy<\/a>, but POSSIBLY related to the investigational therapy, report the event as \"possibly related.\" Indicate on the reporting form the UM PI judgment regarding which part of the therapy the event should be attributed to. If the PI and sponsor disagree on the assessment, so note in the report.<\/td>\r\n<\/tr>\r\n<tr>\r\n<td style=\"width: 95px\"><strong>Step 5<\/strong><\/td>\r\n<td style=\"width: 391px\" colspan=\"2\">Based on the event's relatedness and expectedness, report it within the timeframe indicated on the\u00a0Standard Adverse Event Reporting chart above.<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>","legacy_media_position":false,"legacy_media_file":null,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"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\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA <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.\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: February 23, 2026, 11:15 AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/732","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":6,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/732\/revisions"}],"predecessor-version":[{"id":1880,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/732\/revisions\/1880"}],"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\/865"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/774"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/863"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=732"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=732"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=732"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=732"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=732"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=732"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}