[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-243307-105":53,"doc-detail-243307-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","serious-adverse-event-report-form-fill-in-clinical-sae-reporting-details","Serious Adverse Event Report Form - Fill-in clinical SAE reporting details","","Serious Adverse Event Report Form designed to capture complete clinical safety information for a participant’s serious adverse event within a study. It collects reporting type and identifiers, site details, participant demographics, event name and detailed description, SAE start/stop dates and awareness timing, and the specific seriousness criteria. It also records relevant medical history, laboratory results, study drug exposure and action taken, concomitant and non-study medications, and the event outcome including mortality and post-mortem information, plus follow-up status and reporter sign-off.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/serious-adverse-event-report-form-fill-in-clinical-sae-reporting-details/243307/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/serious-adverse-event-report-form-fill-in-clinical-sae-reporting-details/243307.png","ImageObject",442,249,{"name":88,"@type":89},"Sage","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-23","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What information is required to identify the SAE report and determine whether it is initial or follow-up?","Question",{"text":108,"@type":109},"The form requests the SAE number, the form number for the SAE, and selection of Initial report or Follow-up information depending on whether the SAE was previously reported.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should the seriousness of the event be classified on the form?",{"text":113,"@type":109},"Select the most/most significant reason that makes the event serious (e.g., fatal, life threatening, requiring hospitalization, disability, or other important medical event) and document any additional applicable reasons in the event description.",{"name":115,"@type":106,"acceptedAnswer":116},"What fields are used to document study drug exposure and management actions related to the SAE?",{"text":117,"@type":109},"The form collects study drug name, dose, frequency, route, dates started and (if applicable) stopped, whether the event resolved after stopping, whether it reappeared after reintroduction, and action(s) taken such as discontinued temporarily, dose reduced, or discontinued.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},243307,1789995976,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":47,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":73},687197207057,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","27/02/2024 , 11:42 Serious Adverse Event Report Form  \nSerious Adverse Event Report Form  \n\n| Serious Adverse Event |  |  |  |\n| --- | --- | --- | --- |\n| 1. Report type | * | *\u003Cbr>SAE number\u003Cbr>If this CRF relates to the patient 's first SAE, enter 1. If the patient has had more than one SAE, please record the SAE number that this applies to | *\u003Cbr>Form number (for this SAE)\u003Cbr>If this is the initial report, enter 1. If this is a follow-up form, please record the number of CRFs you have attempted to complete for this SAE, including this one |\n| If this is the first time the SAE has been reported, please select\"Initial report \". If you are submitting new, updated or corrected information for a previously reported SAE, please select \"Follow-up information \".\u003Cbr> Initial report  Follow-up information |  |  |  |\n| » 2. Site |  |  |  |\n| Site name |  | Site name (if not in list) |  |\n| » 2. Site |  |  |  |\n| Site name |  | Site name (if not in list) |  |\n| » 3. Participant details |  |  |  |\n| Study number |  |  |  |\n| Participant's initials |  |  |  |\n| *\u003Cbr>Date of birth\u003Cbr>yyyy-mm-dd |  |  |  |\n| Patient's year of birth |  |  |  |\n| Sex\u003Cbr> Male  Female |  |  |  |\n\n[https://npeu.openclinica.io/OpenClinica/EnketoFormServlet?formLayoutId=101&studyEventId=0&eventCrfId=0&originatingPage=&mode=preview](https://npeu.openclinica.io/OpenClinica/EnketoFormServlet?formLayoutId=101&studyEventId=0&eventCrfId=0&originatingPage=&mode=preview) 1/5  \n27/02/2024 , 11:42 Serious Adverse Event Report Form  \n\n| 4.1 Adverse event name\u003Cbr>Description of SAE in a few words at most e.g. Pneumonia, Seizure, Gastrointestinal bleed |  |  |\n| --- | --- | --- |\n| 4.2 Adverse Event description\u003Cbr>Please record: i) diagnosis if known, ii) an account of the event (including signs and symptoms if diagnosis not known), iii) any interventions given to manage the event (including dates for these), and iv) if the event was fatal, the cause of death if known |  |  |\n| 5. Start date of SAE\u003Cbr>yyyy-mm-dd | Start time of SAE\u003Cbr>(hh:mm [24 hr]) |  |\n| 6. Stop date of SAE\u003Cbr>yyyy-mm-dd | Stop time of SAE\u003Cbr>(hh:mm [24 hr]) | or Ongoing?\u003Cbr> Yes |\n| 7. Date site became aware of SAE\u003Cbr>yyyy-mm-dd | Time site became aware of SAE\u003Cbr>(hh:mm [24 hr]) |  |\n| 8. Reason this event is classed as serious\u003Cbr>If there is more than one reason which applies then choose the more/most significant one and document other reason(s) in the AE description\u003Cbr> Fatal  Life threatening  Requiring/prolonging hospitalisation  Congenital anomaly/birth defect  Significant disability/incapacity  Other important medical event\u003Cbr> Event does not fulfil criteria for being serious |  |  |\n| The RECOVERY protocol does not require non-serious events to be recorded. Please check your answer. |  |  |\n|  |  |  |\n| 9. Relevant medical history\u003Cbr>Provide a full description of any medical history which could be relevant to this SAE and which may need to be considered by the individual reviewing the event (including co-existing medical conditions, allergies or similar experiences) |  |  |\n| 10. Laboratory results relevant to the SAE\u003Cbr>Please give details of relevant results, dates and reference ranges in the space below or send a printout with these details highlighted and patient identifiable information obscured |  |  |\n| If this event is believed to be related to more than one study treatment, please press the + button to add a new row. |  |  |\n\n[https://npeu.openclinica.io/OpenClinica/EnketoFormServlet?formLayoutId=101&studyEventId=0&eventCrfId=0&originatingPage=&mode=preview](https://npeu.openclinica.io/OpenClinica/EnketoFormServlet?formLayoutId=101&studyEventId=0&eventCrfId=0&originatingPage=&mode=preview) 2/5  \n27/02/2024 , 11:42 Serious Adverse Event Report Form  \n11. Specify the study drug details below (for the drug this SAE is believed to be  \nrelated to)  \nStudy drug name  \nDose Frequency Route Date  \nstarted  \nyyyy-mm-dd  \nIf discontinued, date stopped  \nyyyy-mm-dd  \nDid the event resolve after stopping ","cbCaiuauWsmvCr05","https://ap.wps.com/l/cbCaiuauWsmvCr05","pdf",211246,"English","# Section 1: Reporting metadata\n## Report type and form/SAE numbers\n## Site information\n# Section 2: Participant and event details\n## Participant identifiers and demographics\n## Adverse event name and description\n## SAE start/stop and awareness dates/times\n## Seriousness classification criteria\n# Section 3: Clinical context and results\n## Relevant medical history\n## Laboratory results relevant to the SAE\n## Study drug details and actions taken\n## Concomitant and non-study medications\n# Section 4: Outcome and follow-up\n## Outcome of event and death details\n## Further information and follow-up reporting\n## Reporter signature and completion date","[{\"question\":\"What information is required to identify the SAE report and determine whether it is initial or follow-up?\",\"answer\":\"The form requests the SAE number, the form number for the SAE, and selection of Initial report or Follow-up information depending on whether the SAE was previously reported.\"},{\"question\":\"How should the seriousness of the event be classified on the form?\",\"answer\":\"Select the most/most significant reason that makes the event serious (e.g., fatal, life threatening, requiring hospitalization, disability, or other important medical event) and document any additional applicable reasons in the event description.\"},{\"question\":\"What fields are used to document study drug exposure and management actions related to the SAE?\",\"answer\":\"The form collects study drug name, dose, frequency, route, dates started and (if applicable) stopped, whether the event resolved after stopping, whether it reappeared after reintroduction, and action(s) taken such as discontinued temporarily, dose reduced, or discontinued.\"}]","Serious Adverse Event Report Form - Fill-in clinical SAE reporting details | PDF",1789202495]