{"id":98,"date":"2023-01-23T22:27:01","date_gmt":"2023-01-23T22:27:01","guid":{"rendered":"https:\/\/in.nau.edu\/human-research-protection-program\/?page_id=98"},"modified":"2023-02-06T22:02:20","modified_gmt":"2023-02-06T22:02:20","slug":"reporting","status":"publish","type":"page","link":"https:\/\/in.nau.edu\/human-research-protection-program\/guidance\/reporting\/","title":{"rendered":"Reporting local event information"},"content":{"rendered":"<h1>Reporting local information<\/h1>\n<p>Investigators must report the following information to the IRB within ten (10) business days of discovery, except as otherwise noted. All reportable items must be submitted on a Reportable Local Information Form. Non-local items requiring changes to the protocol should be reported on a Request for Amendment form.<\/p>\n<h2>Events to report<\/h2>\n<ul>\n<li>Unanticipated Problems (UP) involving Risks to subjects or others:\n<ul>\n<li>a. Are unanticipated;<\/li>\n<li>b. Are related or possibly related to participation in the research; and<\/li>\n<li>c. Suggest that human subjects or others are at increased risk of harm<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"padding-left: 40px;\"><strong>NOTE:<\/strong> UPs that involve a death must be reported to the IRB within 24 hours of discovery.4. A breach of confidentiality involving a subject (e.g. unapproved use or disclosure of PHI)<\/p>\n<ul>\n<li>Information that indicates a new or increased risk (change in the frequency or magnitude of risks or benefits):\n<ul>\n<li>a. An interim analysis or monitoring report<\/li>\n<li>b. Published paper or presentation<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li>Withdrawal, restriction, or modification of drug\/device\/biological approval from the FDA or Sponsor<\/li>\n<li>A breach of confidentiality involving a subject (e.g. unapproved use or disclosure of PHI)<\/li>\n<li>Changes to the protocol made without prior IRB review to eliminate an apparent immediate hazard to subjects<\/li>\n<\/ul>\n<p style=\"padding-left: 40px;\"><strong>NOTE:<\/strong> Changes made to eliminate risk must be reported to the IRB within 5 business days of discovery<\/p>\n<ul>\n<li>Complaint of a subject that indicated unexpected risks or that cannot be resolved by the study team.<\/li>\n<li>Audit, inspection, or inquiry by a Federal Agency (FDA 483, FDA Warning letters, FDA Audit reports, Notice of Disqualification, OHRP Determination letter, Debarment or Restricted list)<\/li>\n<li>Medical license suspension, restrictions or revocations, or any licensure or credentialing issues involving PI, co-PI, sub-I, or research staff<\/li>\n<li>Incarceration of a subject enrolled in a protocol not approved to enroll prisoners<\/li>\n<li>Protocol violations due to investigator or research staff<\/li>\n<li>Unanticipated adverse device effect (UADEs): Any serious effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application [including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects<\/li>\n<li>Any other problem that the PI believes needs to be reported promptly to the IRB<\/li>\n<li>Any conflict of Interest previously undisclosed or managed<\/li>\n<\/ul>\n<p><em>Version 2019-8\u00a0<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Reporting local information Investigators must report the following information to the IRB within ten (10) business days of discovery, except as otherwise noted. All reportable items must be submitted on a Reportable Local Information Form. Non-local items requiring changes to the protocol should be reported on a Request for Amendment form. Events to report Unanticipated [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":190,"parent":45,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","ring_central_script_selection":"","footnotes":""},"class_list":["post-98","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages\/98","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/comments?post=98"}],"version-history":[{"count":3,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages\/98\/revisions"}],"predecessor-version":[{"id":302,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages\/98\/revisions\/302"}],"up":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages\/45"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/media\/190"}],"wp:attachment":[{"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/media?parent=98"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}