{"id":890,"date":"2021-07-23T10:57:35","date_gmt":"2021-07-23T10:57:35","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/multi-site-and-performance-site-applications-reporting-irbmed\/"},"modified":"2026-03-13T11:07:20","modified_gmt":"2026-03-13T15:07:20","slug":"multi-site-and-performance-site-applications-reporting-irbmed","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/multi-site-and-performance-site-applications-reporting-irbmed\/","title":{"rendered":"Multi-Site and Performance Site applications: Reporting to IRBMED"},"template":"","categories":[24],"tags":[50,78],"content-type":[41],"topic":[76,43,66],"update-type":[98],"class_list":["post-890","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-ctso-work-guide","tag-study-coordinator","content-type-guidance","topic-adverse-events-other-reportable-information-and-occurrences","topic-eresearch-regulatory-management-errm","topic-investigator-study-team-responsibilities","update-type-new-resource"],"acf":{"use_legacy_editor":true,"updated_date":"2021-07-23 14:00:00","update_notice":true,"author":"IRBMED","summary":"This document provides the reporting requirements to IRBMED for both Multi-Site HUM application and Performance Site HUM application when U-M\r\n<ul>\r\n \t<li><em>is<\/em> a coordinating center<\/li>\r\n \t<li><em>is not<\/em> the single IRB (sIRB)\/IRB of record\/reviewing IRB for sites other than U-M.<\/li>\r\n<\/ul>\r\nWhen U-M IRBMED is the sIRB\/IRB of record\/reviewing IRB, follow the\u00a0<a href=\"https:\/\/www.dropbox.com\/s\/jxdc1se4x8ul97m\/sIRB%20Research%20Reporting%20plan.pdf?dl=0\">sIRB Research reporting plan<\/a>\u00a0available in the IRBMED\u00a0<a href=\"https:\/\/www.dropbox.com\/sh\/x9hptlep26gc8g1\/AADdnvnj1S0UbJ8_mwbRpODCa?dl=0\">Multi-site Research Documents<\/a>\u00a0folders.","button_links":null,"related_content":[881,863],"legacy_path":"multi-site-and-performance-site-applications-reporting-irbmed","legacy_node_id":1596,"legacy_related_nids":"1520, 522","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Reporting Table","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":"link_button","legacy_heading":"","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":[{"legacy_button":{"title":"PDF version of Reporting Table","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed-MS-PS-Reporting-Table.pdf","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<table border=\"1\" cellspacing=\"1\" cellpadding=\"1\">\r\n<thead>\r\n<tr>\r\n<th scope=\"col\">Report Type<\/th>\r\n<th scope=\"col\">Within Multi-Site Application HUM Reporting\r\n\r\n(Events at non-UM Participating Sites, and reports addressing the whole study \u2013 U-M and other sites)<\/th>\r\n<th scope=\"col\">Within Performance Site HUM Application Reporting\r\n\r\n(Events at U-M Site)<\/th>\r\n<\/tr>\r\n<\/thead>\r\n<tbody>\r\n<tr>\r\n<td><strong>SAEs<\/strong><\/td>\r\n<td>N\/A (unless UaP - see below)<\/td>\r\n<td>Report per<a href=\"\/medschool\/guidance\/adverse-event-reporting\"> Adverse Event Reporting<\/a> or approved <a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/study-specific-adverse-event-ae-reporting-plans\/\">Study-Specific Reporting Plan<\/a>.<\/td>\r\n<\/tr>\r\n<tr>\r\n<td><strong>UaPs, including both AEs and ORIOs<\/strong><\/td>\r\n<td>Report UaPs per <a href=\"\/medschool\/policies\/statement-practice-external-adverse-event-reports-unanticipated-problems\">Statement of Practice: External Adverse Event Reports Unanticipated Problems<\/a>.\r\n\r\nIdentify in the submission title whether the UaP is or will be accompanying an Amendment updating study documents (ICD, protocol, IB, etc.)<\/td>\r\n<td>Report potential UaPs per <a href=\"\/medschool\/guidance\/unanticipated-problems-involving-risks-subjects-or-others\">Unanticipated Problems Involving Risks to Subjects or Others<\/a>.<\/td>\r\n<\/tr>\r\n<tr>\r\n<td><strong>Deviations, including time-sensitive modifications<\/strong><\/td>\r\n<td><strong>Report within 7 days of becoming aware of the event or information<\/strong>:\r\n<ul>\r\n \t<li>Protocol deviations that may represent a systematic problem requiring local evaluation by IRBMED to determine that sufficient local resources are available for safe conduct of the study<\/li>\r\n \t<li>Major protocol deviations that may impact the safety of subjects (including breaches of confidentiality) and\/or put the institution at risk<\/li>\r\n \t<li>Deviations from eligibility criteria for one or two subjects. <em>(Not available for investigator-initiated studies managed through O-CTSU.)<\/em><\/li>\r\n<\/ul>\r\n<\/td>\r\n<td>Report per <a href=\"\/medschool\/guidance\/other-reportable-information-or-occurrence-orio\">Other Reportable Information or Occurrence (ORIO) Guidance<\/a>\r\n\r\nIf seeking IRB approval beforehand: See guidance <a href=\"\/medschool\/guidance\/reporting-time-sensitive-modifications\">Time-Sensitive Modifications<\/a><\/td>\r\n<\/tr>\r\n<tr>\r\n<td><strong>Data and Safety Monitoring (DSMB, DSMC, DMC) Correspondence (Reports, Letters)<\/strong><\/td>\r\n<td>\r\n<ul>\r\n \t<li>Submit determination \/ outcome reports received individually during the year per <a href=\"\/medschool\/guidance\/other-reportable-information-or-occurrence-orio\">Other Reportable Information or Occurrence (ORIO) Guidance<\/a>.<\/li>\r\n \t<li>Annual summary report (<em>e.g.<\/em> CERVANT report for oncology) must be submitted as part of SCR (upload into 4.1).\r\n<ul>\r\n \t<li>On the summary, identify any reports previously submitted individually by writing the Adv# next to the item(s).<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<\/td>\r\n<td>\r\n<ul>\r\n \t<li>If determination \/ outcome requires a response from UM (i.e., UM site action item), report as an ORIO per IRB reporting guidance.\r\n<ul>\r\n \t<li>When a single report addresses U-M and external events, Performance Site ORIO should respond only to the U-M event(s).<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td><strong>Annual Report to the FDA<\/strong><\/td>\r\n<td>If the IND\/IDE holder is from UM, upload into the SCR submission\r\n\r\nN\/A if the IND\/IDE holder is not from UM<\/td>\r\n<td><em>N\/A<\/em><\/td>\r\n<\/tr>\r\n<tr>\r\n<td><strong>Other Correspondence to the FDA (i.e. amendment)<\/strong><\/td>\r\n<td>Upload into eResearch <a href=\"https:\/\/documentation.its.umich.edu\/node\/1263\">in an amendment<\/a><\/td>\r\n<td><em>N\/A<\/em><\/td>\r\n<\/tr>\r\n<tr>\r\n<td><strong>Other ORIOs<\/strong><\/td>\r\n<td>Anything else that affects the entire study, e.g.:\r\n<ul>\r\n \t<li>Safety information that could affect risk to participants, or otherwise require changes to study materials<\/li>\r\n \t<li>Termination of study\u00a0with all remaining patients in FU taken off study;<\/li>\r\n \t<li>Closure to accrual;<\/li>\r\n \t<li>Response to <a href=\"https:\/\/sites.google.com\/a\/umich.edu\/prc\/home\">Protocol Review Committee (PRC)<\/a> due to low accrual for the entire study<\/li>\r\n<\/ul>\r\n<\/td>\r\n<td>Report per <a href=\"\/medschool\/guidance\/other-reportable-information-or-occurrence-orio\">Other Reportable Information or Occurrence (ORIO) Guidance<\/a>\r\n\r\nIn many cases, a report from the Coordinating Center to Performance Sites can be submitted by Performance Site as part of SCR.<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>","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":[98],"update_notice_start":"2021-07-23 10:45:00","update_notice_end":"2021-09-24 14:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>This new resource consolidates recommendations for AE\/ORIO reporting requirements for studies where U-M has a coordinating center and performance site function, but no \"<a href=\"\/medschool\/guidance\/single-irb-sirb-and-cooperative-multi-site-research\">sIRB<\/a>\" function. (IRBMED&nbsp;approved both a \"Multi-Site\" and a \"Performance Site\" application.)<\/p>"}],"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\nA list of IRBMED staff is available at <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">our webpage<\/a>.\r\n\r\nEdited By:\u00a0<a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: March 13, 2026 11:05AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/890","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\/890\/revisions"}],"predecessor-version":[{"id":1924,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/890\/revisions\/1924"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/98"}],"acf:post":[{"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\/881"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=890"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=890"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=890"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=890"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=890"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}