{"id":5996,"date":"2024-06-05T18:49:32","date_gmt":"2024-06-05T22:49:32","guid":{"rendered":"https:\/\/umaine.edu\/research-compliance\/?page_id=5996"},"modified":"2025-04-02T17:51:02","modified_gmt":"2025-04-02T21:51:02","slug":"adverse-event-reporting","status":"publish","type":"page","link":"https:\/\/umaine.edu\/research-compliance\/animal-care\/adverse-event-reporting\/","title":{"rendered":"Adverse Event Reporting for Animals"},"content":{"rendered":"<script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\nvar gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),document.addEventListener(\"gform\/theme\/scripts_loaded\",function(){gform.themeScriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,themeScriptsLoaded:!1,isFormEditor:()=>\"function\"==typeof 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gform-theme--no-framework' data-form-theme='legacy' data-form-index='0' id='gform_wrapper_2' >\n                        <div class='gform_heading'>\n                            <h3 class=\"gform_title\">Adverse Event Reporting Form for Animals at the University of Maine<\/h3>\n                            <p class='gform_description'><\/p>\n                        <\/div><form method='post' enctype='multipart\/form-data'  id='gform_2'  action='\/research-compliance\/wp-json\/wp\/v2\/pages\/5996' data-formid='2' novalidate>\n                        <div class='gform-body gform_body'><ul id='gform_fields_2' class='gform_fields top_label form_sublabel_below description_below validation_below'><li id=\"field_2_2\" class=\"gfield gfield--type-date gfield--input-type-datepicker gfield--datepicker-default-icon gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label 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aria-expanded='false' aria-controls='input_2_2' aria-label='Today's date:: Choose date on calendar' >\n\t\t\t\t\t\t\t<span class=\"gform-calendar-icon gform-datepicker-toggle-icon gform-datepicker-toggle-icon--default dashicons dashicons-calendar-alt\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t<\/button>\n\t\t\t<\/div><\/li><li id=\"field_2_4\" class=\"gfield gfield--type-text gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_4'><span class='gform-field-label__text'>Name of individual initiating this report:<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_4' id='input_2_4' type='text' value='' class='large'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li 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gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_6' id='input_2_6' type='text' value='' class='large'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_2_7\" class=\"gfield gfield--type-text gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_7'><span class='gform-field-label__text'>Protocol #:<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_7' id='input_2_7' type='text' value='' class='medium'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_2_9\" class=\"gfield gfield--type-text gfield_contains_required field_sublabel_below gfield--no-description 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class='ginput_container ginput_container_radio'><ul class='gfield_radio' id='input_2_12'>\n\t\t\t<li class='gchoice gchoice_2_12_0'>\n\t\t\t\t<input name='input_12' type='radio' value='Level of mortality experienced are &gt;10% that anticipated in approved protocol.'  id='choice_2_12_0'    \/>\n\t\t\t\t<label for='choice_2_12_0' id='label_2_12_0' class='gform-field-label gform-field-label--type-inline'>Level of mortality experienced are &gt;10% that anticipated in approved protocol.<\/label>\n\t\t\t<\/li>\n\t\t\t<li class='gchoice gchoice_2_12_1'>\n\t\t\t\t<input name='input_12' type='radio' value='Mortality due to unanticipated complications involving the approved protocol.'  id='choice_2_12_1'    \/>\n\t\t\t\t<label for='choice_2_12_1' id='label_2_12_1' class='gform-field-label gform-field-label--type-inline'>Mortality due to unanticipated complications involving the approved protocol.<\/label>\n\t\t\t<\/li>\n\t\t\t<li class='gchoice gchoice_2_12_2'>\n\t\t\t\t<input name='input_12' type='radio' value='Morbidity\/non-fatal complications significantly beyond that anticipated in the approved protocol.'  id='choice_2_12_2'    \/>\n\t\t\t\t<label for='choice_2_12_2' id='label_2_12_2' class='gform-field-label gform-field-label--type-inline'>Morbidity\/non-fatal complications significantly beyond that anticipated in the approved protocol.<\/label>\n\t\t\t<\/li>\n\t\t\t<li class='gchoice gchoice_2_12_3'>\n\t\t\t\t<input name='input_12' type='radio' value='gf_other_choice'  id='choice_2_12_3'   onfocus=\"jQuery(this).next('input').focus();\" \/>\n\t\t\t\t<input class='small' id='input_2_12_other' name='input_12_other' type='text' value='Other' aria-label='Other' onfocus='jQuery(this).prev(\"input\")[0].click(); if(jQuery(this).val() == \"Other\") { jQuery(this).val(\"\"); }' onblur='if(jQuery(this).val().replace(\" \", \"\") == \"\") { jQuery(this).val(\"Other\"); }'   \/>\n\t\t\t<\/li><\/ul><\/div><\/li><li id=\"field_2_18\" class=\"gfield gfield--type-section gsection field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><h2 class=\"gsection_title\">Briefly summarize the excessive or unanticipated mortality or morbidity being reported including:<\/h2><\/li><li id=\"field_2_14\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_14'><span class='gform-field-label__text'>a) Species involved:<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_14' id='input_2_14' class='textarea small'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_2_20\" class=\"gfield gfield--type-text gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_20'><span class='gform-field-label__text'>b) Numbers of animals impacted:<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_20' id='input_2_20' type='text' value='' class='medium'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_2_19\" class=\"gfield gfield--type-text gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_19'><span class='gform-field-label__text'>c) Date or date range of incidents:<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_19' id='input_2_19' type='text' value='' class='medium'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_2_17\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_17'><span class='gform-field-label__text'>d) Describe the adverse event(s) that occurred:<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_17' id='input_2_17' class='textarea medium'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_2_21\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_21'><span class='gform-field-label__text'>e) Please list the preliminary cause for the adverse event:<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_21' id='input_2_21' class='textarea medium'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_2_22\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_22'><span class='gform-field-label__text'>f) Please list any pending diagnostics or other reports that may explain the cause(s) of the adverse event:<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_22' id='input_2_22' class='textarea medium'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_2_23\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_23'><span class='gform-field-label__text'>g) Any additional information, extenuating circumstances or other detail that may be helpful in reviewing this matter.<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_23' id='input_2_23' class='textarea medium'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_2_24\" class=\"gfield gfield--type-radio gfield--type-choice gfield_contains_required field_sublabel_below gfield--has-description field_description_below field_validation_below gfield_visibility_visible gfield--choice-align-vertical\"  ><label class='gfield_label gform-field-label' ><span class='gform-field-label__text'>Has there been prior communication or consultation with the Attending Veterinarian concerning this event?<\/span><span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_radio'><ul class='gfield_radio' id='input_2_24'>\n\t\t\t<li class='gchoice gchoice_2_24_0'>\n\t\t\t\t<input name='input_24' type='radio' value='Yes'  id='choice_2_24_0'    \/>\n\t\t\t\t<label for='choice_2_24_0' id='label_2_24_0' class='gform-field-label gform-field-label--type-inline'>Yes<\/label>\n\t\t\t<\/li>\n\t\t\t<li class='gchoice gchoice_2_24_1'>\n\t\t\t\t<input name='input_24' type='radio' value='No'  id='choice_2_24_1'    \/>\n\t\t\t\t<label for='choice_2_24_1' id='label_2_24_1' class='gform-field-label gform-field-label--type-inline'>No<\/label>\n\t\t\t<\/li><\/ul><\/div><div class='gfield_description' id='gfield_description_2_24'>If yes, please provide details below.<\/div><\/li><li id=\"field_2_26\" class=\"gfield gfield--type-textarea field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_26'><span class='gform-field-label__text'>Details of prior communication or consultation:<\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_26' id='input_2_26' class='textarea medium'      aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_2_27\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_2_27'><span class='gform-field-label__text'>Please describe the corrective action plan to reduce or prevent future morbidity or mortality. 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