[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-169242-en":3,"doc-seo-169242-105":30,"detail-sidebar-cat-1-en-105":93},{"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},169242,2336475104362,"Mali","https://ap-avatar.wpscdn.com/avatar/22000c4c46a41b752dd?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786595829695023868",1,158,"General","Template Clinical Trial Agreement - RECITALS","Draft agreement for commercial clinical trials, structured with a recitals section and operative provisions. The document sets key definitions governing the relationship among sponsor, institution and investigator, covering study protocol references, the agreement scope and schedules, applicable laws including Good Clinical Practice and data protection regimes, and clinical documentation such as case report forms. It further defines patient-related personal data, pseudonymised trial data, human bodily material, intellectual property rights, protocol versions and binding amendment conditions.","DRAFT AGREEMENT FOR CLINICAL TRIALS\u0005\nStudy Protocol n° [INSERT NUMBER]\nCenter: [INSERT NUMBER]\n\u0005\nAND\t\t\t[INSERT NAME]\nhereinafter referred to as “INVESTIGATOR”,\nThe INSTITUTION, the INVESTIGATOR and the SPONSOR are hereinafter individually referred to as “Party” and collectively referred to as the “Parties”.\u0005\nRECITALS\nWHEREAS, the SPONSOR wishes to perform a clinical study with [INSERT STUDY DRUG NAME];\nWHEREAS, the SPONSOR wishes to retain the Institution and INVESTIGATOR and the Institution and Investigator wish to be retained by the SPONSOR to perform the clinical study as set forth herein, using funds provided by the SPONSOR ;\nWHEREAS, the Investigator is experienced in the evaluation and treatment of [INSERT DISEASE / DRUG NAME] and is willing to conduct the above mentioned clinical study according to the Protocol and the principles of Good Clinical Practices;\nNOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions and any sums to be paid, the Parties hereto agree as follows:\n\u000fOPERATIVE PROVISIONS\nDEFINITIONS\u0005\n“Agreement” means the present agreement for the Study and its schedules;\n“Applicable Laws” means the current version of the World Medical Association’s Declaration of Helsinki, applicable international, European, national and local laws, rules and regulations relating to clinical trials, medical devices and the use of human bodily material for research purposes; the guidelines and guidance documents specifying Good Clinical Practice (“GCP”); all applicable rules and legislation in relation data protection and the processing of personal data (including the General Data Protection Regulation 2016/679 (“GDPR”), the Belgian law of 30 July 2018 on the protection of individuals with regard to the processing of personal data and or other applicable Belgian or European regulation in relation to the processing of personal data), patient’s rights, and the Belgian Sunshine Act implemented by the Royal Decree of 14 June 2017;\n“Case report form” or “CRF” means and includes any document - printed, optical, electronic or others - designed to record all Protocol information required to be reported to the SPONSOR for each patient participating in the Study (“Study Participant”). The CRF shall be reported electronically between the Parties. The Parties agree that CRF’s data reported electronically shall have the same probative force as scriptural data or signature;\n“Pseudonymised Clinical Trial Personal Data” means any Personal Data that is collected, pseudonymised and provided by the INSTITUTION to the SPONSOR for the sole purpose of the Study as described in Annex 1;\n“Human Bodily Material” means in accordance with the law of 19 December 2008 regarding the procurement and use of human bodily material destined for human medical applications or for scientific research purposes, every biological bodily material, including human tissues and cells, as well as substances extracted therefrom, whatever the degree to which they have been processed;\n“Intellectual Property Rights” means any and all patent rights (including but not limited to divisionals, extensions, improvement patents, supplementary protection certificates), know-how, trademarks, copyrights (including moral rights), trade and business names, domain names, rights in and to databases (including the right to prevent the extraction or reutilisation of information from a database), design rights, topography rights and any other rights or forms of protection of a similar nature or having equivalent or similar effect, whether or not registered and including all applications for registration of any of foregoing;\n“Personal Data” means any information relating to an identified or identifiable natural person (“Data Subject”) as defined in Applicable Laws, including without limitation Pseudonymized Clinical Trial Personal Data;\n“Protocol” means the document entitled [INSERT NAME] dated [INSERT DATE] and bearing the number [INSERT NU","cbCaicPlqJCQ3Hca","https://ap.wps.com/l/cbCaicPlqJCQ3Hca","docx",113880,41,"English","en",105,"# Definitions\n## Parties and agreement scope\n## Applicable laws and compliance\n## Clinical documentation and data concepts\n## Human bodily material and intellectual property\n## Protocol definitions and amendments","[{\"question\":\"Who are the Parties to the clinical trial agreement and how are they referenced?\",\"answer\":\"The Parties are the SPONSOR, the INSTITUTION and the INVESTIGATOR, each referred to individually as a “Party” and collectively as the “Parties”.\"},{\"question\":\"What does the agreement define as “Applicable Laws” for the trial?\",\"answer\":\"“Applicable Laws” includes the Declaration of Helsinki, relevant international/European/national/local rules for clinical trials and medical devices, Good Clinical Practice guidance, and data protection and patient-rights legislation including GDPR and specific Belgian regulations.\"},{\"question\":\"What are the conditions for substantial amendments to the Protocol?\",\"answer\":\"Substantial amendments bind only if agreed in writing by the SPONSOR, the INVESTIGATOR and the responsible ethics committee, and attached to the Protocol as a Protocol amendment. “Substantial” relates to impacts on participant safety or changes to scientific document interpretation, or other significant effects.\"}]","Template Clinical Trial Agreement - RECITALS | DOCX",1788249031,14,{"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":88,"head_meta":90,"extra_data":92,"updated_unix":28},"template-clinical-trial-agreement-recitals","",{"@graph":36,"@context":87},[37,54,70],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"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":50},"https://docshare.wps.com/template/general/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/template-clinical-trial-agreement-recitals/169242/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":63,"encodingFormat":61,"isAccessibleForFree":64,"interactionStatistic":65},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-05","2026-09-01",true,{"@type":66,"interactionType":67,"userInteractionCount":69},"InteractionCounter",{"@type":68},"ViewAction",6,{"@type":71,"mainEntity":72},"FAQPage",[73,79,83],{"name":74,"@type":75,"acceptedAnswer":76},"Who are the Parties to the clinical trial agreement and how are they referenced?","Question",{"text":77,"@type":78},"The Parties are the SPONSOR, the INSTITUTION and the INVESTIGATOR, each referred to individually as a “Party” and collectively as the “Parties”.","Answer",{"name":80,"@type":75,"acceptedAnswer":81},"What does the agreement define as “Applicable Laws” for the trial?",{"text":82,"@type":78},"“Applicable Laws” includes the Declaration of Helsinki, relevant international/European/national/local rules for clinical trials and medical devices, Good Clinical Practice guidance, and data protection and patient-rights legislation including GDPR and specific Belgian regulations.",{"name":84,"@type":75,"acceptedAnswer":85},"What are the conditions for substantial amendments to the Protocol?",{"text":86,"@type":78},"Substantial amendments bind only if agreed in writing by the SPONSOR, the INVESTIGATOR and the responsible ethics committee, and attached to the Protocol as a Protocol amendment. “Substantial” relates to impacts on participant safety or changes to scientific document interpretation, or other significant effects.","https://schema.org",{"og:url":52,"og:type":89,"og:title":14,"og:site_name":59,"og:description":15},"article",{"robots":91,"canonical":52},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":94},[95,100,105,109,114,119,124,129,134],{"id":96,"doc_module":11,"doc_module_name":46,"category_name":97,"show_sort_weight":98,"slug":99},11,"Presentations",90,"presentations",{"id":101,"doc_module":11,"doc_module_name":46,"category_name":102,"show_sort_weight":103,"slug":104},12,"Resumes",80,"resumes",{"id":29,"doc_module":11,"doc_module_name":46,"category_name":106,"show_sort_weight":107,"slug":108},"Invoices",70,"invoices",{"id":110,"doc_module":11,"doc_module_name":46,"category_name":111,"show_sort_weight":112,"slug":113},15,"Posters",60,"posters",{"id":115,"doc_module":11,"doc_module_name":46,"category_name":116,"show_sort_weight":117,"slug":118},16,"Social Media",50,"social-media",{"id":120,"doc_module":11,"doc_module_name":46,"category_name":121,"show_sort_weight":122,"slug":123},17,"Forms",40,"forms",{"id":125,"doc_module":11,"doc_module_name":46,"category_name":126,"show_sort_weight":127,"slug":128},18,"Letters",30,"letters",{"id":130,"doc_module":11,"doc_module_name":46,"category_name":131,"show_sort_weight":132,"slug":133},21,"Paper Templates",5,"papers-templates",{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":4,"slug":135},"general-158"]