{"id":769,"date":"2018-05-08T06:52:48","date_gmt":"2018-05-08T06:52:48","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/investigator-responsibilities\/"},"modified":"2026-03-13T11:00:46","modified_gmt":"2026-03-13T15:00:46","slug":"investigator-responsibilities","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/investigator-responsibilities\/","title":{"rendered":"Investigator Responsibilities"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[66],"update-type":[],"class_list":["post-769","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-investigator-study-team-responsibilities"],"acf":{"use_legacy_editor":true,"updated_date":"2012-04-17 09:45:00","update_notice":false,"author":"IRBMED","summary":"","button_links":null,"related_content":"","legacy_path":"investigator-responsibilities","legacy_node_id":311,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Department of Health and Human Services","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_with_subheading","legacy_heading":"","legacy_subheading":"Food and Drug Administration","legacy_section_text":"<ul>\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>\u00a0(Also see the\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/adverse-events-aes-other-reportable-information-and-occurrences-orios-other\">UM Required Reporting<\/a>)<\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/information-sheet-guidance-sponsors-clinical-investigators-and-irbs-frequently-asked-questions\">Form FDA 1572, Frequently Asked Questions--Statement of Investigator<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM187772.pdf\">Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigator<\/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":"","legacy_subheading":"Office of Human Research Protections","legacy_section_text":"<ul>\r\n \t<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/reviewing-unanticipated-problems\/index.html\">Adverse Event and Unanticipated Problem Reporting<\/a>\u00a0(Also see the\u00a0<a href=\"\/medschool\/guidance\/adverse-events-aes-other-reportable-information-and-occurrences-orios-other\">UM Required Reporting<\/a>)<\/li>\r\n \t<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/faq\/index.html\">FAQs<\/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":"heading","legacy_heading":"University of Michigan","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":"<ul>\r\n \t<li><a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">Human Research Protection Program, Operations Manual<\/a> Part 6, Roles and Responsibilities of Investigators and Research Staff<\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/adverse-events-aes-other-reportable-information-and-occurrences-orios-other\">Required Reporting: Adverse Events, Other Reportable Information and Occurences, and Unanticipated Problems Involving Risks to Subjects and Others<\/a><\/li>\r\n<\/ul>\r\n&nbsp;\r\n\r\n&nbsp;\r\n\r\nCreated 4\/17\/2012\r\nLast reviewed (no revisions) October 30, 2023","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\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:\u00a0<a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: March 13, 11:00AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/769","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":3,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/769\/revisions"}],"predecessor-version":[{"id":1920,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/769\/revisions\/1920"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=769"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=769"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=769"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=769"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=769"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=769"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}