{"id":1432,"date":"2022-06-02T13:49:44","date_gmt":"2022-06-02T17:49:44","guid":{"rendered":"https:\/\/research.ncsu.edu\/administration\/?page_id=1432"},"modified":"2022-10-19T16:02:55","modified_gmt":"2022-10-19T20:02:55","slug":"report-unanticipated-or-adverse-events-form","status":"publish","type":"page","link":"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/irb-forms-and-templates\/report-unanticipated-or-adverse-events-form\/","title":{"rendered":"Report Unanticipated or Adverse Events Form"},"content":{"rendered":"<script type=\"text\/javascript\">var 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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class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_complex ginput_container ginput_container--name no_prefix has_first_name no_middle_name has_last_name no_suffix gf_name_has_2 ginput_container_name gform-grid-row' id='input_21_1'>\n                            \n                            <span id='input_21_1_3_container' class='name_first gform-grid-col gform-grid-col--size-auto' >\n                                                    <input type='text' name='input_1.3' id='input_21_1_3' value=''   aria-required='true'     \/>\n                                                    <label for='input_21_1_3' class='gform-field-label gform-field-label--type-sub '>First<\/label>\n                                                <\/span>\n                            \n                            <span id='input_21_1_6_container' class='name_last gform-grid-col gform-grid-col--size-auto' >\n                                                    <input type='text' name='input_1.6' id='input_21_1_6' value=''   aria-required='true'     \/>\n                                                    <label for='input_21_1_6' class='gform-field-label gform-field-label--type-sub '>Last<\/label>\n                                                <\/span>\n                            \n                        <\/div><\/li><li id=\"field_21_2\" class=\"gfield gfield--type-email gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_2\" ><label class='gfield_label gform-field-label' for='input_21_2'>PI Email<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_email'>\n                            <input name='input_2' id='input_21_2' type='email' value='' class='medium'    aria-required=\"true\" aria-invalid=\"false\"  \/>\n                        <\/div><\/li><li id=\"field_21_3\" class=\"gfield gfield--type-phone gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_3\" ><label class='gfield_label gform-field-label' for='input_21_3'>PI Phone<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_phone'><input name='input_3' id='input_21_3' type='tel' value='' class='medium'   aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_21_5\" class=\"gfield gfield--type-text field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_5\" ><label class='gfield_label gform-field-label' for='input_21_5'>NC State Affiliation (college, department, unit, or center)<\/label><div class='ginput_container ginput_container_text'><input name='input_5' id='input_21_5' type='text' value='' class='medium'      aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_21_7\" class=\"gfield gfield--type-text gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_7\" ><label class='gfield_label gform-field-label' for='input_21_7'>Protocol Title<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_21_7' type='text' value='' class='medium'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_21_6\" class=\"gfield gfield--type-text gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_6\" ><label class='gfield_label gform-field-label' for='input_21_6'>Protocol eIRB Number<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_6' id='input_21_6' type='text' value='' class='medium'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_21_8\" class=\"gfield gfield--type-text field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_8\" ><label class='gfield_label gform-field-label' for='input_21_8'>Funding Source (if applicable)<\/label><div class='ginput_container ginput_container_text'><input name='input_8' id='input_21_8' type='text' value='' class='medium'      aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_21_9\" 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\"  data-js-reload=\"field_21_9\" ><label class='gfield_label gform-field-label' for='input_21_9'>Date<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_date'>\n                            <input name='input_9' id='input_21_9' type='text' value='' class='datepicker gform-datepicker mdy datepicker_with_icon gdatepicker_with_icon'   placeholder='mm\/dd\/yyyy' aria-describedby=\"input_21_9_date_format\" aria-invalid=\"false\" aria-required=\"true\"\/>\n                            <span id='input_21_9_date_format' class='screen-reader-text'>MM slash DD slash YYYY<\/span>\n                        <\/div>\n                        <input type='hidden' id='gforms_calendar_icon_input_21_9' class='gform_hidden' value='https:\/\/research.ncsu.edu\/administration\/wp-content\/plugins\/gravityforms\/images\/datepicker\/datepicker.svg'\/><\/li><li id=\"field_21_10\" class=\"gfield gfield--type-time gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_10\" ><label class='gfield_label gform-field-label gfield_label_before_complex' >Time<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class=\"ginput_container ginput_complex gform-grid-row\"><div class=\"clear-multi\">\n                        <div class='gfield_time_hour ginput_container ginput_container_time gform-grid-col' id='input_21_10'>\n                            <input type='number' maxlength='2' name='input_10[]' id='input_21_10_1' value=''  min='0' max='12' step='1'  placeholder='HH' aria-required='true'   \/> <i>:<\/i>\n                            <label class='gform-field-label gform-field-label--type-sub hour_label screen-reader-text' for='input_21_10_1'>Hours<\/label>\n                        <\/div>\n                        \n                        <div class='gfield_time_minute ginput_container ginput_container_time gform-grid-col'>\n                            <input type='number' maxlength='2' name='input_10[]' id='input_21_10_2' value=''  min='0' max='59' step='1'  placeholder='MM' aria-required='true'  \/>\n                            <label class='gform-field-label gform-field-label--type-sub minute_label screen-reader-text' for='input_21_10_2'>Minutes<\/label>\n                        <\/div>\n                        <div class='gfield_time_ampm ginput_container ginput_container_time below gform-grid-col' >\n                                \n                                <select name='input_10[]' id='input_21_10_3'  >\n                                    <option value='am' >AM<\/option>\n                                    <option value='pm' >PM<\/option>\n                                <\/select> \n                                <label class='gform-field-label gform-field-label--type-sub am_pm_label screen-reader-text' for='input_21_10_3'>AM\/PM<\/label>                                \n                           <\/div>\n                    <\/div><\/div><\/li><li id=\"field_21_11\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_11\" ><label class='gfield_label gform-field-label' for='input_21_11'>Briefly describe what happened:<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_11' id='input_21_11' class='textarea medium'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_21_12\" class=\"gfield gfield--type-select gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_12\" ><label class='gfield_label gform-field-label' for='input_21_12'>Did the event cause physical or psychological harm to a participant?<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_select'><select name='input_12' id='input_21_12' class='medium gfield_select'    aria-required=\"true\" aria-invalid=\"false\" ><option value='Select One' selected='selected'>Select One<\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/li><li id=\"field_21_13\" class=\"gfield gfield--type-select gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_13\" ><label class='gfield_label gform-field-label' for='input_21_13'>Did the event cause permanent harm to a participant?<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_select'><select name='input_13' id='input_21_13' class='medium gfield_select'    aria-required=\"true\" aria-invalid=\"false\" ><option value='Select One' selected='selected'>Select One<\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/li><li id=\"field_21_14\" class=\"gfield gfield--type-select gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_21_14\" ><label class='gfield_label gform-field-label' for='input_21_14'>Please choose a reason for the event you\u2019re reporting to have occurred:\u00a0<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_select'><select name='input_14' id='input_21_14' class='medium gfield_select'    aria-required=\"true\" aria-invalid=\"false\" ><option value='Select One' selected='selected'>Select One<\/option><option value='Event is unlikely to be related to research procedure(s)' >Event is unlikely to be related to research procedure(s)<\/option><option value='Unknown whether event was related to research procedure(s)\u00a0' >Unknown whether event was related to research procedure(s)\u00a0<\/option><option value='Event was likely or definitely related to research procedure(s)' >Event was likely or definitely related to research procedure(s)<\/option><\/select><\/div><\/li><\/ul><\/div>\n        <div class='gform-footer gform_footer 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