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Defines responsibilities for protocol compliance, staff training and qualification, recruitment and enrollment stop rules, and handling protocol deviations for medical emergencies with documentation to the Sponsor. Specifies reporting of study findings to Sponsor at defined intervals, investigator supervision, successor appointment, and pharmacovigilance information sharing, including prompt notification of serious adverse events within 24 hours.",{"@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/clinical-study-site-agreement-template-clinical-trial-agreement-for-academic-trials/164343/",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/clinical-study-site-agreement-template-clinical-trial-agreement-for-academic-trials/164343.png","ImageObject",442,249,{"name":88,"@type":89},"Aditya","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-22","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":76},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What does the Participating Site and Investigator need to do to comply with the agreement?","Question",{"text":108,"@type":109},"They must perform (part of) the study at the participating site facilities fully in accordance with the protocol, the agreement (including appendices), and applicable laws and regulations, including staff training and qualification requirements.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"When can the protocol be deviated from, and how must it be documented?",{"text":113,"@type":109},"The protocol should not be deviated from except when required due to a medical emergency. If deviations are needed, the alternatives/deviations and reasons must be documented and forwarded to the Sponsor as described in the protocol.",{"name":115,"@type":106,"acceptedAnswer":116},"What are the Investigator’s pharmacovigilance and adverse event notification obligations?",{"text":117,"@type":109},"The Investigator must provide Sponsor pharmacovigilance information (e.g., SAEs, SUSARs) in English according to EU guidance, and use best efforts to notify the Sponsor of serious adverse events within 24 hours.","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},164343,1788151656,{"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":76,"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":125,"read_time":140},962085564549,"https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","CLINICAL\u0005 STUDY\u0005 SITE AGREEMENT\n\u0003Universitair Ziekenhuis Brussel\u0004, located at \u0003Laarbeeklaan 101, 1090 Brussel\u0004, legally represented by \u0003prof. dr. Marc Noppen\u0004, CEO, VAT number \u00030449.012.406 (business unit number: 2.143.464.230)\u0004 (hereinafter: “Sponsor”),\nAND\n\u0003Klik hier als u tekst wilt invoeren.\u0004, located at \u0003Klik hier als u tekst wilt invoeren.\u0004, legally represented by \u0003Klik hier als u tekst wilt invoeren.\u0004, CEO, VAT registration number \u0003Klik hier als u tekst wilt invoeren.\u0004 (hereinafter: ”Participating Site”), in the presence of \u0003Klik hier als u tekst wilt invoeren.\u0004 \u0003Klik hier als u tekst wilt invoeren.\u0004\nIN THE PRESENCE OF\n….. (hereinafter (“Investigator”)\nSponsor and the Participating Site are hereinafter also referred to individually as a “Party” and collectively as the “Parties”.\u0005\nAND\n….. (hereinafter (“Investigator”)\nSponsor, Investigator and the Participating Site are hereinafter also referred to individually as a “Party” and collectively as the “Parties”.\u0005\nWHEREAS:\nSponsor has initiated the clinical study (the “Study\") as set out in the document that describes the objective(s), design, methodology, statistical considerations and organisation of the Study, including – but not limited to - the clinical trial plan that defines the clinical tests to be performed on and/or with the “Study Drug” (as defined in Article 12) (\"Protocol\") entitled: [study title].\nSponsor has appointed [….] as Principal Investigator for conducting the Study [at the Department of …] with […] as the head of the Department].Principal Investigator shall coordinate the Study which will be performed at the Participating Site.\nSponsor wishes to have part of the Study performed at the Participating Site under the supervision of Investigator who is willing to perform under the terms of this Agreement;\nNOW THEREFORE IT HAS BEEN AGREED AS FOLLOWS\nResponsibilities of the Parties\n1.1 Participating Site and Investigator\nParticipating Site\nThe Participating Site and Investigator will perform (part of) the Study at Participating Site’s facilities fully in accordance with the terms of the Protocol, this Agreement including all its appendices and Applicable Laws and Regulations (as defined as follows: the current version of the World Medical Association’s Declaration of Helsinki, the guidelines and guidance documents specifying Good Clinical Practice (“GCP”) and guidelines of competent authorities; all applicable laws, rules and legislation in relation to clinical trials, use of human biological material, data protection and the processing of personal data, and patient’s rights, including but not limited to the General Data Protection Regulation 2016/679 (“GDPR”) and the Belgian law of 30 July 2018 on the protection of natural persons with regard to the processing of personal data). The Participating Site will ensure that the Investigator and all employees, agents, contractors and/or the representatives  involved in the performance of the Study (jointly “Staff”) are properly trained and sufficiently qualified. The Participating Site shall provide Staff with all necessary documentation to allow the proper performance of the Study, which shall be conducted in compliance with the Protocol. The Participating Site shall be responsible to ensure that all work performed by Staff is done in compliance with the Protocol, this Agreement and all Applicable laws and Regulations. The Participating Site undertakes to impose on all employees, agents, contractors and/ or representatives the terms and conditions not less strict than those set out in this Agreement.\nThe Study requires the Participating Site through Investigator to recruit participants for the Study, as described in the Protocol (“Study Subjects”). Enrolment will be stopped as soon as the total number of Study Subjects to be enrolled in this Study, if multicenter, has been reached or has been anticipated to be reached based on the actual number of the screened Study Subjects by all involved participating sites/inve","cbCaidiTnvPNqpiQ","https://ap.wps.com/l/cbCaidiTnvPNqpiQ","docx",89192,22,"English","# Responsibilities of the Parties\n## Participating Site and Investigator\n## Investigator","[{\"question\":\"What does the Participating Site and Investigator need to do to comply with the agreement?\",\"answer\":\"They must perform (part of) the study at the participating site facilities fully in accordance with the protocol, the agreement (including appendices), and applicable laws and regulations, including staff training and qualification requirements.\"},{\"question\":\"When can the protocol be deviated from, and how must it be documented?\",\"answer\":\"The protocol should not be deviated from except when required due to a medical emergency. If deviations are needed, the alternatives/deviations and reasons must be documented and forwarded to the Sponsor as described in the protocol.\"},{\"question\":\"What are the Investigator’s pharmacovigilance and adverse event notification obligations?\",\"answer\":\"The Investigator must provide Sponsor pharmacovigilance information (e.g., SAEs, SUSARs) in English according to EU guidance, and use best efforts to notify the Sponsor of serious adverse events within 24 hours.\"}]","CLINICAL STUDY SITE AGREEMENT - Template Clinical Trial Agreement for Academic Trials | DOCX",8]