[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-174244-en":3,"doc-seo-174244-105":30,"detail-sidebar-cat-1-en-105":90},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":21,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":22,"language":23,"language_code":24,"site_id":25,"html_lang":24,"table_of_contents":26,"faqs":27,"seo_title":28,"seo_description":15,"update_tm":29,"read_time":11},174244,2336474466712,"Quinn Holloway","https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd",1,17,"Forms","Serious Adverse Event (SAE) Report Form","This document is a Serious Adverse Event (SAE) Report Form designed for collecting detailed information about any serious adverse events that occur during a clinical study. It meticulously captures essential data points pertaining to the event, including the study name, protocol number, site name, participant identification, and the dates of participant reporting or site awareness. The form requires the SAE event term (diagnosis), onset date, and stop date. Crucially, it asks whether the adverse event was unexpected for the participant and seeks a brief, non-identifying description of the participant, including their sex and age, along with their diagnosis for study participation. A comprehensive description of the nature of the SAE is solicited, with provisions for attaching additional details if space is insufficient. The form categorizes the severity of the SAE, including life-threatening events, hospitalizations, disabilities, congenital anomalies, and those requiring intervention to prevent permanent impairment, with an option for 'Other'. It also specifies the type of intervention, such as medication, device, surgery, or behavioral/lifestyle changes. The relationship of the event to the study intervention is assessed as unrelated, possible, or definite. Further, it ascertains if the study intervention was discontinued due to the event and details the medications or other treatments administered for the SAE. The form also provides space to list relevant tests, laboratory data, and medical history, including pre-existing conditions. Finally, it determines if the event was a study-related endpoint and specifies the type of report (Initial, Follow-up, or Final), concluding with a signature line for the principal investigator and the date.","Serious Adverse Event (SAE) \u000bReport Form\nSTUDY NAME\nProtocol Number:\nSite Name:\nPt ID:\n\u000eDate Participant Reported/Date of Site Awareness:\n/                   /                        .\nd\td\tm\tm\tm\ty\ty\ty\ty\nSAE Event Term (Diagnosis, ex: Stroke, Myocardial Infarction).\nSAE onset date:\t___ ___ / ___ ___ ___ / ___ ___ ___ ___\nd\td\tm\tm\tm\ty\ty\ty\ty\nSAE stop date: \t___ ___ / ___ ___ ___ / ___ ___ ___ ___\nd\td\tm\tm\tm\ty\ty\ty\ty\nLocation of SAE:\nWas this an unexpected adverse event?\nYes\nNo\nBrief description of participant with no personal identifiers:\nSex:\nF\nM\tAge:\nDiagnosis for study participation:\nBrief description of the nature of the SAE (attach description if more space is needed):\nCategory of the SAE:\nDate of death\t___/_____/_______\n(dd/mmm/yyyy)\nLife threatening\nHospitalization – initial or prolonged\nDisability/incapacity\n\u000e\nCongenital anomaly/birth defect\nRequired intervention to prevent permanent impairment\nOther:\nIntervention type:\nMedication or nutritional supplement (specify):\nDevice (specify):\nSurgery (specify):\nBehavioral/lifestyle (specify):\nRelationship of event to intervention:\nUnrelated (clearly not related to the intervention)\nPossible (may be related to the intervention)\nDefinite (clearly related to the intervention)\nWas study intervention discontinued due to event?\nYes\nNo\nWhat medications or other steps were taken to treat the SAE?\nList any relevant tests, laboratory data, and history, including preexisting medical conditions.\nWas this event a study related endpoint?\nType of report:\nInitial\nFollowup\nFinal\nSignature of principal investigator: \t\tDate:","cbCaikS8JB7wHdTL","https://ap.wps.com/l/cbCaikS8JB7wHdTL","docx",64156,3,2,"English","en",105,"# Serious Adverse Event (SAE) Report Form\n## Study Details\n## Event Details\n## Participant Information\n## SAE Details\n## Intervention and Relationship\n## Treatment and History\n## Report Status","[{\"question\":\"What information is required on the Serious Adverse Event (SAE) Report Form?\",\"answer\":\"The form requires study details like name and protocol number, event details such as SAE term, onset and stop dates, and participant information including sex and age. It also details the nature, category, and relationship of the SAE to the intervention, along with treatment and medical history.\"},{\"question\":\"How are Serious Adverse Events categorized on this form?\",\"answer\":\"SAEs are categorized based on their severity and impact, including life-threatening events, hospitalizations, disabilities or incapacities, congenital anomalies or birth defects, and events requiring intervention to prevent permanent impairment. An 'Other' category is also available.\"},{\"question\":\"What are the possible relationships between an event and the study intervention as per the form?\",\"answer\":\"The form assesses the relationship as 'Unrelated' (clearly not related), 'Possible' (may be related), or 'Definite' (clearly related) to the study intervention.\"}]","Serious Adverse Event (SAE) Report Form | DOCX",1788311414,{"code":4,"msg":31,"data":32},"ok",{"site_id":25,"language":24,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":85,"head_meta":87,"extra_data":89,"updated_unix":29},"serious-adverse-event-sae-report-form","",{"@graph":36,"@context":84},[37,52,67],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,47,49],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":22},"https://docshare.wps.com/template/","Template",{"item":48,"name":13,"@type":43,"position":21},"https://docshare.wps.com/template/forms/",{"item":50,"name":14,"@type":43,"position":51},"https://docshare.wps.com/template/serious-adverse-event-sae-report-form/174244/",4,{"url":50,"name":14,"@type":53,"author":54,"headline":14,"publisher":56,"fileFormat":59,"inLanguage":24,"description":15,"dateModified":60,"datePublished":61,"encodingFormat":59,"isAccessibleForFree":62,"interactionStatistic":63},"DigitalDocument",{"name":9,"@type":55},"Person",{"url":41,"name":57,"@type":58},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-04","2026-09-02",true,{"@type":64,"interactionType":65,"userInteractionCount":21},"InteractionCounter",{"@type":66},"ViewAction",{"@type":68,"mainEntity":69},"FAQPage",[70,76,80],{"name":71,"@type":72,"acceptedAnswer":73},"What information is required on the Serious Adverse Event (SAE) Report Form?","Question",{"text":74,"@type":75},"The form requires study details like name and protocol number, event details such as SAE term, onset and stop dates, and participant information including sex and age. It also details the nature, category, and relationship of the SAE to the intervention, along with treatment and medical history.","Answer",{"name":77,"@type":72,"acceptedAnswer":78},"How are Serious Adverse Events categorized on this form?",{"text":79,"@type":75},"SAEs are categorized based on their severity and impact, including life-threatening events, hospitalizations, disabilities or incapacities, congenital anomalies or birth defects, and events requiring intervention to prevent permanent impairment. An 'Other' category is also available.",{"name":81,"@type":72,"acceptedAnswer":82},"What are the possible relationships between an event and the study intervention as per the form?",{"text":83,"@type":75},"The form assesses the relationship as 'Unrelated' (clearly not related), 'Possible' (may be related), or 'Definite' (clearly related) to the study intervention.","https://schema.org",{"og:url":50,"og:type":86,"og:title":14,"og:site_name":57,"og:description":15},"article",{"robots":88,"canonical":50},"index,follow",{"doc_id":7,"site_id":25},{"code":4,"msg":5,"data":91},[92,97,102,107,112,117,120,125,130],{"id":93,"doc_module":11,"doc_module_name":46,"category_name":94,"show_sort_weight":95,"slug":96},11,"Presentations",90,"presentations",{"id":98,"doc_module":11,"doc_module_name":46,"category_name":99,"show_sort_weight":100,"slug":101},12,"Resumes",80,"resumes",{"id":103,"doc_module":11,"doc_module_name":46,"category_name":104,"show_sort_weight":105,"slug":106},14,"Invoices",70,"invoices",{"id":108,"doc_module":11,"doc_module_name":46,"category_name":109,"show_sort_weight":110,"slug":111},15,"Posters",60,"posters",{"id":113,"doc_module":11,"doc_module_name":46,"category_name":114,"show_sort_weight":115,"slug":116},16,"Social Media",50,"social-media",{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":118,"slug":119},40,"forms",{"id":121,"doc_module":11,"doc_module_name":46,"category_name":122,"show_sort_weight":123,"slug":124},18,"Letters",30,"letters",{"id":126,"doc_module":11,"doc_module_name":46,"category_name":127,"show_sort_weight":128,"slug":129},21,"Paper Templates",5,"papers-templates",{"id":131,"doc_module":11,"doc_module_name":46,"category_name":132,"show_sort_weight":4,"slug":133},158,"General","general-158"]