[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-172908-105":53,"doc-detail-172908-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","model-clinical-trial-agreement-instruction-pages-checklist","Model Clinical Trial Agreement - Instruction Pages Checklist","","Instruction pages for a model Clinical Trial Agreement (mCTA) providing a practical checklist of information required to complete the template prior to execution by the parties. Includes guidance to fill footer and front page fields, manage the contents page references to unused appendices, and tailor recitals to the specific clinical trial context. Details clause-level edits such as updating the Declaration of Helsinki reference, removing inapplicable transplantation or phase-related provisions, selecting enrols/doses/randomises and target numbers, and configuring GDPR and PIC authorisation language where applicable, plus completing signature and appendix sections including milestones, finances, equipment, and delegation.",{"@graph":63,"@context":119},[64,80,102],{"@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":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/model-clinical-trial-agreement-instruction-pages-checklist/172908/",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/model-clinical-trial-agreement-instruction-pages-checklist/172908.png","ImageObject",442,249,{"name":88,"@type":89},"Gelato","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-19","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",10,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What information must be completed before executing the model Clinical Trial Agreement (mCTA)?","Question",{"text":109,"@type":110},"Complete all required fields on the front page and footer, and ensure recitals are added, removed, or updated to match the specific clinical trial and legal context.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"How should parties handle inapplicable clauses and references within the main body?",{"text":114,"@type":110},"Delete clauses that do not apply (e.g., transplantation provisions, phase I or dose-escalation dose provisions, and subcontracting clauses) and adjust references such as the Declaration of Helsinki version to match the trial.",{"name":116,"@type":107,"acceptedAnswer":117},"What GDPR-related language guidance is provided regarding Participant Identification Centres (PICs)?",{"text":118,"@type":110},"Delete highlighted text when PICs are not permitted; retain it when PICs are permitted under a general written authorisation that meets GDPR Article 28(2) requirements, ensuring the Trial Site obtains specific written authorisation only when required.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},172908,1788297493,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":22,"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":126,"read_time":140},19241457091524,"https://us-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","Model Clinical Trial Agreement\nInstruction Pages\nThe information set out below provides a checklist of information that needs to be included in the model Clinical Trial Agreement (mCTA) in preparation for execution by the Parties.\nIt is the Sponsor’s responsibility to provide the required information for review by the Trial Site.\nFooters\nComplete the information set out in the footer of this document.\nFront page\nComplete all of the required information.\nContents page\nIf Appendices 6, 7, 8 and / or 9 are not used, delete reference(s) in the Contents Page.\nRecitals\nAdd, remove and / or update recitals as applicable to the Clinical Trial (as a preamble to the Agreement, such changes do not constitute modification to the template Agreement). Recital D should be completed where a corporate Affiliate of the Sponsor is formally empowered by the Sponsor to sign the Agreement on behalf of the Sponsor thereby binding the Sponsor as Party to the Agreement (and should be removed where this is not the case). Recital E should be retained if the Trial Site is in Northern Ireland and otherwise deleted.\nMain Body of the Agreement\nClause 3.3.4 – Check that this Clause references the version of the Declaration of Helsinki applicable to this Clinical Trial and update where needed.\nClause 3.3.7 – Delete if the Clinical Trial does not involve transplantation of human cells, tissue or organs.\nClause 3.6.1 – Delete if the Clinical Trial is not a Phase I clinical trial.\nClause 3.6.2 – Delete if the Clinical Trial is not a dose escalation Phase I clinical trial.\nClause 4.6.1 – Delete the non-applicable version of this subclause depending upon whether a request to defer registration has been submitted.\nClause 4.13 – Select ‘enrols’, ‘doses’ or ‘randomises’ as appropriate to the Clinical Trial and inset target number for the Trial Site.\nClause 4.15 – Delete if it is NOT intended that the Trial Site will subcontract with Other Trial Sites.\nClause 4.16.9 – Insert the appropriate number of years.\nClause 4.16.9.b – Insert e-mail address for Trial Site archiving contact.\nClauses 4.16.10 and 4.16.11 – Delete either or both clauses depending upon whether Material will be analysed locally, centrally or if no Material will be analysed. Where no Material will be analysed, delete the definition ‘Material’.\nClause 4.17 – Delete if no equipment or resources are provided by the Sponsor.\nClause 5.6 – Insert amount.\nClause 6.2.6 – The yellow highlighted text should be deleted: i) where the Sponsor does not intend to permit the use of Participant Identification Centres (PICs) in the Clinical Trial; ii) where the Sponsor does intend to permit the use of PICs in the Clinical Trial but, in accordance with GDPR Article 28(2), requires the Trial Site to obtain specific written authorisation from or on behalf of the Sponsor prior to engaging a PIC. The yellow highlighted text should be retained where the Sponsor does intend to permit the use of PICs in the Clinical Trial and, in accordance with GDPR Article 28(2), authorises the Trial Site to engage PICs under this general written authorisation.\nClause 18 – Complete the full names, addresses (and e-mail addresses, as applicable) for contact persons for notices to the Parties.\nSignature page\nIt is a requirement in Scotland, and best practice throughout the UK, that the signature pages of the Agreement are part of the body of the Agreement. Please therefore ensure that the last clause of the Agreement appears on the same page as the signature block.\nAppendix 1\nComplete Appendix 1 showing the milestones / division of responsibilities between the Parties and target Site completion date.\nAppendix 4\nThe interactive Costing Tool (iCT) generated Finance Schedule should be inserted into this Financial Arrangements Appendix.  Further detailed guidance for completion is included within the Financial Arrangements Appendix itself.\nAppendix 6\nAppendix 6 should be omitted if not relevant to the specific Clinical Trial.\nAppendix 7\nComplete de","cbCailUMJvK9cFZ4","https://ap.wps.com/l/cbCailUMJvK9cFZ4","docx",138621,"English","# Recitals\n## Main Body of the Agreement\n## Clause Completion Guidance\n# Signature Page\n# Appendices","[{\"question\":\"What information must be completed before executing the model Clinical Trial Agreement (mCTA)?\",\"answer\":\"Complete all required fields on the front page and footer, and ensure recitals are added, removed, or updated to match the specific clinical trial and legal context.\"},{\"question\":\"How should parties handle inapplicable clauses and references within the main body?\",\"answer\":\"Delete clauses that do not apply (e.g., transplantation provisions, phase I or dose-escalation dose provisions, and subcontracting clauses) and adjust references such as the Declaration of Helsinki version to match the trial.\"},{\"question\":\"What GDPR-related language guidance is provided regarding Participant Identification Centres (PICs)?\",\"answer\":\"Delete highlighted text when PICs are not permitted; retain it when PICs are permitted under a general written authorisation that meets GDPR Article 28(2) requirements, ensuring the Trial Site obtains specific written authorisation only when required.\"}]","Model Clinical Trial Agreement - Instruction Pages Checklist | DOCX",25]