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Defines the scope of safety event classifications including AEs, ARs, SAEs, SARs, SUSARs and IMEs, and clarifies that classifications may overlap. Sets responsibilities for Chief Investigators, Principal Investigators and KHP-CTO staff, and outlines key procedures for assessing relatedness, handling adverse and serious adverse events, SUSAR processing, contraception and pregnancy reporting, and important medical events.",{"@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":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/pharmacovigilance-and-safety-reporting-policy-v100/244510/",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/pharmacovigilance-and-safety-reporting-policy-v100/244510.png","ImageObject",442,249,{"name":88,"@type":89},"Arica Lee","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-21","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":9},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of the Pharmacovigilance and Safety Reporting Policy?","Question",{"text":108,"@type":109},"It sets out the KHP-CTO approach to managing pharmacovigilance and safety reporting for CTIMPs sponsored by KHP.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which safety event classifications are covered by the policy?",{"text":113,"@type":109},"The policy covers AEs, ARs, SAEs, SARs, SUSARs and Important Medical Events (IMEs), which are defined in the glossary.",{"name":115,"@type":106,"acceptedAnswer":116},"How does the policy treat overlap between safety event classifications?",{"text":117,"@type":109},"Classifications are not mutually exclusive; an event can be an AE and also an SAE, a SAR and a SUSAR where applicable.","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},244510,1789991105,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":73,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":141},8796096645457,"https://ap-avatar.wpscdn.com/avatar/800003749518d68ffe3?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779345340919836971","Pharmacovigilance and Safety Reporting Policy  \n\n| DOCUMENT DETAILS |  |\n| --- | --- |\n| Document Type | Operational Policy |\n| Document Name | Pharmacovigilance and Safety Reporting |\n| Version | v10.0 |\n| Effective from | 28 Apr 2026 |\n| Review date | 28 Apr 2029 |\n| Owner | King’s Health Partners Clinical Trials Office |\n| Prepared by | Docusign version on file\u003Cbr>Kathryn Lobb, Quality Assurance Associate |\n| Reviewed by | Docusign version on file\u003Cbr>Craig Macpherson, Interim Operations Manager |\n| Approved by | Docusign version on file\u003Cbr>Ann-Marie Murtagh, Director KHP-CTO |\n\nContents  \n1. BACKGROUND AND PURPOSE ..........................................................................3  \n2. SCOPE ..................................................................................................................3  \n3. PROCEDURES .....................................................................................................4  \n3.1 General Roles and Responsibilities ....................................................................4  \n3.2 Assessing the relatedness of AEs and SAEs to the IMP ....................................6  \n3.3 Adverse Event process .......................................................................................7  \n3.4 Serious Adverse Event process ..........................................................................8  \n3.5 Suspected Unexpected Serious Adverse Reaction process .............................10  \n3.6 Contraception process and pregnancy reporting process .................................12  \n3.7 Important Medical Events process .................................................................... 14  \n4. RELATED TEMPLATES ...................................................................................... 15  \n5. RELATED DOCUMENTS .................................................................................... 15  \n6. CHANGE HISTORY ............................................................................................ 16  \n7. GLOSSARY ......................................................................................................... 17  \n1. BACKGROUND AND PURPOSE  \nThis Operational Policy sets out the KHP-CTO’s approach to managing pharmacovigilance and safety reporting for CTIMPs sponsored by KHP.  \n2. SCOPE  \nThis Operational Policy applies to all Clinical Trials sponsored by KHP.  \nThe following safety event classifications are in scope:  \n• Adverse Events (AEs)  \n• Adverse Reactions (ARs)  \n• Serious Adverse Events (SAEs)  \n• Serious Adverse Reactions (SARs)  \n• Suspected Unexpected Serious Adverse Reactions (SUSARs)  \n• Important Medical Event (IME)  \nEach safety event is defined in Section 7: Glossary (below) .  \nPlease note safety event classifications are not mutually exclusive i.e. an AE can also be an SAE, a SAR and a SUSAR.  \nThis Operational Policy applies to the following Clinical Trial staff:  \n• Chief Investigators (who can also be Medical Assessors)  \n• Sponsor Teams  \n• Principal Investigators (who can also be Medical Assessors)  \n• Trial Location Teams  \n• Medical Assessors (with no other role in the Clinical Trial)  \n• KHP-CTO staff, including the:  \no Non-Commercial Trials Manager (NCTM)  \no Clinical Research Associates (CRAs)  \nPlease note this Operational Policy is not an exhaustive list of the policies and procedures that must be followed by Clinical Trial staff, with respect to safety events. Clinical Trial staff may also have to comply with safety event-related policies and procedures operated by:  \n• The Trial Locations (including the sole Sponsor/NHS Co-Sponsor R&D Dept.)  \n• The Funder  \n• The IMP manufacturer  \n• The NIMP manufacturer if applicable  \nThe Chief Investigator is responsible for identifying the safety event-related policies and procedures, operated outside of the KHP-CTO, that need to be followed, and to ensure they’re adhered to.  \n3. PROCEDURES  \n3.1 General Roles and Responsibilities  \nChief Investigator (CI) ","cbCaibLCeDg1MQDp","https://ap.wps.com/l/cbCaibLCeDg1MQDp","pdf",437708,22,"English","# BACKGROUND AND PURPOSE\n# SCOPE\n# PROCEDURES\n## General Roles and Responsibilities\n## Assessing the relatedness of AEs and SAEs to the IMP\n## Adverse Event process\n## Serious Adverse Event process\n## Suspected Unexpected Serious Adverse Reaction process\n## Contraception process and pregnancy reporting process\n## Important Medical Events process\n# RELATED TEMPLATES\n# RELATED DOCUMENTS\n# CHANGE HISTORY\n# GLOSSARY","[{\"question\":\"What is the purpose of the Pharmacovigilance and Safety Reporting Policy?\",\"answer\":\"It sets out the KHP-CTO approach to managing pharmacovigilance and safety reporting for CTIMPs sponsored by KHP.\"},{\"question\":\"Which safety event classifications are covered by the policy?\",\"answer\":\"The policy covers AEs, ARs, SAEs, SARs, SUSARs and Important Medical Events (IMEs), which are defined in the glossary.\"},{\"question\":\"How does the policy treat overlap between safety event classifications?\",\"answer\":\"Classifications are not mutually exclusive; an event can be an AE and also an SAE, a SAR and a SUSAR where applicable.\"}]","Pharmacovigilance and Safety Reporting Policy - v10.0 | PDF",1789218116,8]