[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-166495-en":3,"doc-seo-166495-105":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},166495,962084925782,"Chloe Bennett","https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc",1,18,"Letters","RECITALS - DRAFT AGREEMENT FOR CLINICAL TRIALS","Draft agreement text for clinical trials defining foundational recitals and governing intent between an institution and a sponsor. The recitals describe the sponsor’s plan to conduct a study using a specified study drug, appointing an experienced investigator and institution to perform the trial according to the protocol and Good Clinical Practices. It then introduces operative provisions with key definitions, including affiliates, the agreement scope, applicable laws, case report forms, days, pseudonymized personal data, human bodily material, intellectual property rights, and core roles such as the investigator.","DRAFT AGREEMENT FOR CLINICAL TRIALS\nStudy Protocol n° [INSERT NUMBER]\nCenter: [INSERT NUMBER]\nThe INSTITUTION and the SPONSOR are hereinafter individually referred to as “Party” and collectively referred to as the “Parties”.\nRECITALS\nWHEREAS, the SPONSOR wishes to perform a clinical study with [INSERT STUDY DRUG NAME];\nWHEREAS, the SPONSOR wishes to retain the Institution and [INSERT NAME], hereinafter referred to as the Investigator (as defined in Article \u0013 REF _Ref101456948 \\r \\h  \\* MERGEFORMAT \u00141.9\u0015), 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:\nOPERATIVE PROVISIONS\nDEFINITIONS\n“Affiliate” means, if applicable any business entity which controls, is controlled by, or is under the common control according to article 1:14 of the Belgian Companies and Associations Code of 23 March 2019;\n“Agreement” means the present agreement for the Study (as defined in Article \u0013 REF _Ref5176675 \\r \\h  \\* MERGEFORMAT \u00141.14\u0015) and its schedules;\n“Applicable Laws” means the current version of the World Medical Association’s Declaration of Helsinki, all 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 to 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 natural persons with regard to the processing of personal data and or other applicable Belgian or European regulations 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, and in general all laws, regulations and guidance which are applicable for the performance of the obligations under this Agreement;\n“Case report form” or “CRF” means and includes any document - printed, optical, electronic or others - designed to record all Protocol (as defined in Article \u0013 REF _Ref101967069 \\r \\h  \\* MERGEFORMAT \u00141.12\u0015) information required to be reported to the SPONSOR for each Study Participant (as defined in Article \u0013 REF _Ref101967199 \\r \\h  \\* MERGEFORMAT \u00141.17\u0015). 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“Days” means calendar days unless specific reference is made to “working days”;\n“Pseudonymized Personal Data” means any Personal Data (as defined in Article \u0013 REF _Ref101967254 \\r \\h  \\* MERGEFORMAT \u00141.11\u0015) that is collected, pseudonymised and provided by the INSTITUTION to the SPONSOR for the sole purpose of the Study as described in Annex 1 of \u0013 REF SCHEDULE_F \\h  \\* MERGEFORMAT \u0014SCHEDULE F\u0015\u0013 REF _Ref101972567 \\r \\h  \\* MERGEFORMAT \u0014\u0015;\n“Human Bodily Material” means human bodily material as defined under 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;\n“Intellectual Property Rights”  means any and all patent rights (including but not limited to divisionals, derivatives, extensions, improvement patents, supplementary protection certificates), trademarks, copyrights (including moral rights), trade and business names, domain names, rights in and to databas","cbCaivAVU43ujzbR","https://ap.wps.com/l/cbCaivAVU43ujzbR","docx",130815,45,"English","en",105,"# RECITALS\n## WHEREAS statements\n# OPERATIVE PROVISIONS\n## DEFINITIONS","[{\"question\":\"What do the recitals state about the sponsor and the planned clinical study?\",\"answer\":\"The recitals state that the sponsor wishes to perform a clinical study using the specified study drug name and to retain the institution and investigator to carry out the study.\"},{\"question\":\"Who is the “Investigator” as defined in the document?\",\"answer\":\"The investigator is the principal investigator and refers to the physician or other qualified person responsible for study conduct and supervision, participant welfare during the study, clinical follow-up, study drug distribution, and reporting participant personal data.\"},{\"question\":\"Which laws and standards are included under “Applicable Laws”?\",\"answer\":\"Applicable Laws include the Declaration of Helsinki (current version), relevant international/European/national/local rules for clinical trials and medical devices, Good Clinical Practice guidance, and data protection rules including GDPR and Belgian privacy legislation, plus related patient rights and Belgian Sunshine Act provisions.\"}]","RECITALS - DRAFT AGREEMENT FOR CLINICAL TRIALS | DOCX",1788193997,16,{"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},"recitals-draft-agreement-for-clinical-trials","",{"@graph":36,"@context":85},[37,54,68],{"@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/letters/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/recitals-draft-agreement-for-clinical-trials/166495/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":62,"encodingFormat":61,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-08-31",true,{"@type":65,"interactionType":66,"userInteractionCount":4},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71,77,81],{"name":72,"@type":73,"acceptedAnswer":74},"What do the recitals state about the sponsor and the planned clinical study?","Question",{"text":75,"@type":76},"The recitals state that the sponsor wishes to perform a clinical study using the specified study drug name and to retain the institution and investigator to carry out the study.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"Who is the “Investigator” as defined in the document?",{"text":80,"@type":76},"The investigator is the principal investigator and refers to the physician or other qualified person responsible for study conduct and supervision, participant welfare during the study, clinical follow-up, study drug distribution, and reporting participant personal data.",{"name":82,"@type":73,"acceptedAnswer":83},"Which laws and standards are included under “Applicable Laws”?",{"text":84,"@type":76},"Applicable Laws include the Declaration of Helsinki (current version), relevant international/European/national/local rules for clinical trials and medical devices, Good Clinical Practice guidance, and data protection rules including GDPR and Belgian privacy legislation, plus related patient rights and Belgian Sunshine Act provisions.","https://schema.org",{"og:url":52,"og:type":87,"og:title":14,"og:site_name":59,"og:description":15},"article",{"robots":89,"canonical":52},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":92},[93,98,103,108,113,117,122,125,130],{"id":94,"doc_module":11,"doc_module_name":46,"category_name":95,"show_sort_weight":96,"slug":97},11,"Presentations",90,"presentations",{"id":99,"doc_module":11,"doc_module_name":46,"category_name":100,"show_sort_weight":101,"slug":102},12,"Resumes",80,"resumes",{"id":104,"doc_module":11,"doc_module_name":46,"category_name":105,"show_sort_weight":106,"slug":107},14,"Invoices",70,"invoices",{"id":109,"doc_module":11,"doc_module_name":46,"category_name":110,"show_sort_weight":111,"slug":112},15,"Posters",60,"posters",{"id":29,"doc_module":11,"doc_module_name":46,"category_name":114,"show_sort_weight":115,"slug":116},"Social Media",50,"social-media",{"id":118,"doc_module":11,"doc_module_name":46,"category_name":119,"show_sort_weight":120,"slug":121},17,"Forms",40,"forms",{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":123,"slug":124},30,"letters",{"id":126,"doc_module":11,"doc_module_name":46,"category_name":127,"show_sort_weight":128,"slug":129},21,"Paper Templates",5,"papers-templates",{"id":131,"doc_module":11,"doc_module_name":46,"category_name":132,"show_sort_weight":4,"slug":133},158,"General","general-158"]