[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-166336-en":3,"doc-seo-166336-105":30,"detail-sidebar-cat-1-en-105":91},{"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":4,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":29},166336,2336475104362,"Mali","https://ap-avatar.wpscdn.com/avatar/22000c4c46a41b752dd?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786595829695023868",1,11,"Presentations","Safety data reconciliation - Standard Operating Procedures","Safety data reconciliation SOP defines the purpose, scope, and responsibilities for managing safety data in clinical trials. It establishes standardized definitions for adverse events, adverse events of special interest, line listing, overdose, and serious adverse events, including key decision criteria such as SAE seriousness and grading context. The procedure outlines required planning, review and approval steps, archiving expectations, and the reconciliation workflow for timely reporting and database entry of SAE/AESI/pregnancy/overdose cases.","Standard Operating Procedures for:                                       Safety data reconciliation\n\u0003Table of Contents\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\n\u0013 HYPERLINK \\l \"_Toc180756496\" \u00141.\tPURPOSE\t\u0013 PAGEREF _Toc180756496 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756497\" \u00142.\tSCOPE\t\u0013 PAGEREF _Toc180756497 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756498\" \u00143.\tRESPONSIBLE FUNCTIONS\t\u0013 PAGEREF _Toc180756498 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756499\" \u00144.\tDEFINITIONS and ABBREVIATIONS\t\u0013 PAGEREF _Toc180756499 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756500\" \u00144.1\tAdverse Event (AE)\t\u0013 PAGEREF _Toc180756500 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756501\" \u00144.2\tAdverse Events of Special Interest (AESI)\t\u0013 PAGEREF _Toc180756501 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756502\" \u00144.3\tLine listing\t\u0013 PAGEREF _Toc180756502 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756503\" \u00144.4\tOverdose\t\u0013 PAGEREF _Toc180756503 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756504\" \u00144.5\tSerious Adverse Event (SAE)\t\u0013 PAGEREF _Toc180756504 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756505\" \u00145.\tPROCEDURE\t\u0013 PAGEREF _Toc180756505 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756506\" \u00145.1\tSafety data reconciliation plan\t\u0013 PAGEREF _Toc180756506 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756507\" \u00145.2\tSafety data reconciliation workflow\t\u0013 PAGEREF _Toc180756507 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756508\" \u00145.3\tArchiving\t\u0013 PAGEREF _Toc180756508 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756509\" \u00146.\tREFERENCES\t\u0013 PAGEREF _Toc180756509 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc180756510\" \u00147.\tRELATED TOOLS\t\u0013 PAGEREF _Toc180756510 \\h \u00146\u0015\u0015\n\u0015\u0004\nStandard Operating Procedures for:                                       Safety data reconciliation\nPURPOSE\nSCOPE\nRESPONSIBLE FUNCTIONS\nDEFINITIONS and ABBREVIATIONS\nAdverse Event (AE)\nAny untoward medical occurrence or worsening of a pre-existing medical condition in a clinical trial subject administered a medicinal (investigational) product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable or unintended sign (including laboratory test abnormalities), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not considered related to the investigational product.\nAdverse Events of Special Interest (AESI)\nAdverse Events of scientific and medical concern with the investigational medicinal product(s), for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is appropriate. Such events require further investigation in order to characterize and understand them.\nIn the frame of the endTB and endTB-Q interventional clinical trials, AESI include the list of conditions mentioned in the Clinical Trial Protocols.\nLine listing\nExtraction of the Pharmacovigilance Database (PVDB) where PVDB entries are presented as lines of text.\nOverdose\nAdministration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information or other in-use references (e.g. WHO guidelines). The determination of an overdose will be left to the discretion of the clinical investigator, based on the total dose administered, the emergence of any clinical signs and symptoms suggestive of a toxic administration, as well as his own clinical judgment as it applies to each individual case.\nSerious Adverse Event (SAE)\nAny untoward medical occurrence that at any dose:\nis leading to death;\nis life-threatening (defined as a subject at immediate risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe);\nRequires inpatient hospitalization or prolongation of existing hospitalization, with the exceptions described in the Clinical Trial Protocols;\nresults in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;\nresults in congenital anomaly or birth defect;\nis otherwise considered an important medical event that may not result in death, be immediately life-threatening, or re","cbCaifu1nbbIoThl","https://ap.wps.com/l/cbCaifu1nbbIoThl","docx",55055,7,"English","en",105,"# PURPOSE\n# SCOPE\n# RESPONSIBLE FUNCTIONS\n# DEFINITIONS and ABBREVIATIONS\n## Adverse Event (AE)\n## Adverse Events of Special Interest (AESI)\n## Line listing\n## Overdose\n## Serious Adverse Event (SAE)\n# PROCEDURE\n## Safety data reconciliation plan\n## Safety data reconciliation workflow\n## Archiving\n# REFERENCES\n# RELATED TOOLS","[{\"question\":\"What does “safety data reconciliation” cover in this SOP?\",\"answer\":\"It covers planning, scope, harmonized definitions/mapping, reconciliation formatting, and follow-up queries to ensure consistent safety data handling across trial activities.\"},{\"question\":\"How are adverse events (AE) defined?\",\"answer\":\"An AE is any untoward medical occurrence or worsening of a pre-existing condition in a subject receiving an investigational medicinal product, without necessarily implying a causal relationship.\"},{\"question\":\"When is an event considered a Serious Adverse Event (SAE)?\",\"answer\":\"An SAE is any untoward medical occurrence that meets defined seriousness criteria such as death, life-threatening status, hospitalization or prolongation, persistent significant incapacity, congenital anomaly/birth defect, or other important medical events requiring intervention to prevent outcomes.\"}]","Safety data reconciliation - Standard Operating Procedures | DOCX",1788189604,3,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":86,"head_meta":88,"extra_data":90,"updated_unix":28},"safety-data-reconciliation-standard-operating-procedures","",{"@graph":36,"@context":85},[37,53,68],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,50],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/template/","Template",2,{"item":49,"name":13,"@type":43,"position":29},"https://docshare.wps.com/template/presentations/",{"item":51,"name":14,"@type":43,"position":52},"https://docshare.wps.com/template/safety-data-reconciliation-standard-operating-procedures/166336/",4,{"url":51,"name":14,"@type":54,"author":55,"headline":14,"publisher":57,"fileFormat":60,"inLanguage":23,"description":15,"dateModified":61,"datePublished":62,"encodingFormat":60,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":56},"Person",{"url":41,"name":58,"@type":59},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-01","2026-08-31",true,{"@type":65,"interactionType":66,"userInteractionCount":11},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71,77,81],{"name":72,"@type":73,"acceptedAnswer":74},"What does “safety data reconciliation” cover in this SOP?","Question",{"text":75,"@type":76},"It covers planning, scope, harmonized definitions/mapping, reconciliation formatting, and follow-up queries to ensure consistent safety data handling across trial activities.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"How are adverse events (AE) defined?",{"text":80,"@type":76},"An AE is any untoward medical occurrence or worsening of a pre-existing condition in a subject receiving an investigational medicinal product, without necessarily implying a causal relationship.",{"name":82,"@type":73,"acceptedAnswer":83},"When is an event considered a Serious Adverse Event (SAE)?",{"text":84,"@type":76},"An SAE is any untoward medical occurrence that meets defined seriousness criteria such as death, life-threatening status, hospitalization or prolongation, persistent significant incapacity, congenital anomaly/birth defect, or other important medical events requiring intervention to prevent outcomes.","https://schema.org",{"og:url":51,"og:type":87,"og:title":14,"og:site_name":58,"og:description":15},"article",{"robots":89,"canonical":51},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":92},[93,96,101,106,111,116,121,126,131],{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":94,"slug":95},90,"presentations",{"id":97,"doc_module":11,"doc_module_name":46,"category_name":98,"show_sort_weight":99,"slug":100},12,"Resumes",80,"resumes",{"id":102,"doc_module":11,"doc_module_name":46,"category_name":103,"show_sort_weight":104,"slug":105},14,"Invoices",70,"invoices",{"id":107,"doc_module":11,"doc_module_name":46,"category_name":108,"show_sort_weight":109,"slug":110},15,"Posters",60,"posters",{"id":112,"doc_module":11,"doc_module_name":46,"category_name":113,"show_sort_weight":114,"slug":115},16,"Social Media",50,"social-media",{"id":117,"doc_module":11,"doc_module_name":46,"category_name":118,"show_sort_weight":119,"slug":120},17,"Forms",40,"forms",{"id":122,"doc_module":11,"doc_module_name":46,"category_name":123,"show_sort_weight":124,"slug":125},18,"Letters",30,"letters",{"id":127,"doc_module":11,"doc_module_name":46,"category_name":128,"show_sort_weight":129,"slug":130},21,"Paper Templates",5,"papers-templates",{"id":132,"doc_module":11,"doc_module_name":46,"category_name":133,"show_sort_weight":4,"slug":134},158,"General","general-158"]