[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-169525-en":3,"doc-seo-169525-105":29,"detail-sidebar-cat-1-en-105":90},{"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":11},169525,5909877438554,"Maeve","https://ap-avatar.wpscdn.com/avatar/5600025385ad2bf12a7?_k=1778553567797529272",1,18,"Letters","Harmonised Protocol - Cover Letter Template - version x","Cover letter template for transitioning a Clinical Trial authorised under Directive 2001/20/EC (CTD) to the Clinical Trial Regulation (CTR). Includes placeholders to declare whether Part I documents (protocol, investigators’ brochure and/or IMPD) are fully harmonised or consolidated across concerned Member States, specify trial identifier and document versions, and list non-substantial changes per Annex IV Q&A. Covers IMPD-Q only submission, auxiliary medicinal products listing rules, and any additional transition dossier documents with Member State-specific approval details.","The following information should be provided in the cover letter of applications for transitioning a Clinical Trial authorised under the Directive 2001/20/EC (CTD) to the Clinical Trial Regulation (CTR)\nDescription of changes in vs.3 compared to earlier version: Listing of authorised Auxiliairy Medicinal Products used within marketing authorisation in the cover letter.\nDescription of changes in vs.4 compared to earlier version: Adding guidance on IMPD-Q only submissions in the cover letter.\nDescription of changes in vs.5 – IMPD-Q only submission possible at time of initial application or at subsequent first SM application submission\nEach of the Part I documents Protocol, Investigator’s brochure (IB) and/or Investigational Medicinal Product Dossier (IMPD) for transition is either ____fully harmonised or ___ consolidated (describe/tick as appropriate for each document) across all Member States Concerned.\nI hereby declare that the contents of the submitted version of the respective documents (protocol, IB, IMPD) in relation to the trial [insert EudraCT number] (version x, dated x) have been approved in the following Member States, and do not contain any substantial changes.\nHarmonised Protocol (version x, date x)\n(add rows as appropriate)\nConsolidated Protocol (version x, date x)\nIn case of a consolidated protocol, complete the table below describing Member State-specific aspects (e.g. restricted trial population, particular local requirements etc.) and where they are specified (i.e. annex number or protocol section number)\n(add rows if required). As applicable, similar tabular information with details on each document, Member State, approval dates and particular national aspects should be provided for the harmonised/consolidated IB and/or IMPD.\nNon-substantial changes of Part I documents\nThe following non-substantial changes in line with Annex IV of CLINICAL TRIALS REGULATION (EU) No 536/2014 QUESTIONS & ANSWERS document have been included as compared to approved Part I documents.\nSpecify non-substantial changes in different documents in separate lists, e.g. protocol, and briefly describe the non-substantial changes in each of them\nDocument type, e.g. protocol (version x, date y)\n(add rows as appropriate)\nAdd tables, each with the name of the document in the header (e.g. IB, IMPD) as appropriate if needed for non-substantial changes in line with Annex IV of the European Commission Q&A for other Part I documents.\nOther documents than the minimum Part I and Part II transition dossier approved in some but not all MSCs under the CTD\nIf the Part I Dossier contains documents in addition to the minimum dossier approved by some, but not all MSCs (e.g. DSMB Charter, see CTCG Best Practice Guide for sponsors of multinational clinical trials under Directive 2001/20/EC that will transition to Regulation (EU) No 536/2014), these should be clearly described in the cover letter with information in which Member State the document was approved under CTD.\nFor clarity, Part II documents approved under the CTD are recommended to be listed in a similar way per MSC.\n(add rows as appropriate)\nAuxiliary Medicinal Product\nIf the Auxiliary Medicinal Product (AxMP) is authorised or modified, where such modification does not affect the product quality and/or GMP requirements and is covered by the marketing authorisation, it only requires to be listed in the cover letter. All other AxMPs need to be registered in CTIS.\nIMPD-Q only submission\nIf the sponsor is not the product owner of an IMP used in the trial and the IMPD-Q is already submitted in another trial application in CTIS, a reference to this trial number should be provided in the cover letter. If the IMPD has only been submitted under the CTD, a reference to this trial should be made Although an IMPD-Q only submission (restricted to an IMPD version adopted under CTD) is possible at the time of the initial transition application submission, it is expected to be included at the latest at the time when","cbCaiagHF7nQpfST","https://ap.wps.com/l/cbCaiagHF7nQpfST","docx",37847,3,"English","en",105,"# Cover letter purpose and requested information\n## Changes across versions and IMPD-Q only submission guidance\n## Harmonised or consolidated protocol declaration\n## Non-substantial changes of Part I documents\n## Other transition dossier documents beyond minimum Part I and Part II\n## Auxiliary Medicinal Product rules\n## IMPD-Q only submission requirements\n## Declaration of compliance with published guidance","[{\"question\":\"What information must be included in the cover letter for the CTD to CTR transition?\",\"answer\":\"It must include the description of changes across versions, a declaration on whether Part I documents are fully harmonised or consolidated across concerned Member States, and details on non-substantial changes, additional dossier documents, and approvals per Member State where applicable.\"},{\"question\":\"How should sponsors indicate whether documents are fully harmonised or consolidated?\",\"answer\":\"For each Part I document (protocol, investigators’ brochure and/or IMPD), the cover letter should be completed by ticking or describing whether it is fully harmonised or consolidated across all concerned Member States, with consolidated Member State-specific aspects described in the table.\"},{\"question\":\"When is an IMPD-Q only submission acceptable and what must be referenced?\",\"answer\":\"IMPD-Q only submission is possible for the initial transition application or, at the latest, when submitting the first SM application after transition. The cover letter must reference the relevant CTIS trial number when the IMPD-Q is submitted in another trial.\"}]","Harmonised Protocol - Cover Letter Template - version x | DOCX",1788255996,{"code":4,"msg":30,"data":31},"ok",{"site_id":24,"language":23,"slug":32,"title":14,"keywords":33,"description":15,"schema_data":34,"social_meta":85,"head_meta":87,"extra_data":89,"updated_unix":28},"harmonised-protocol-cover-letter-template-version-x","",{"@graph":35,"@context":84},[36,52,67],{"@type":37,"itemListElement":38},"BreadcrumbList",[39,43,47,49],{"item":40,"name":41,"@type":42,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":44,"name":45,"@type":42,"position":46},"https://docshare.wps.com/template/","Template",2,{"item":48,"name":13,"@type":42,"position":21},"https://docshare.wps.com/template/letters/",{"item":50,"name":14,"@type":42,"position":51},"https://docshare.wps.com/template/harmonised-protocol-cover-letter-template-version-x/169525/",4,{"url":50,"name":14,"@type":53,"author":54,"headline":14,"publisher":56,"fileFormat":59,"inLanguage":23,"description":15,"dateModified":60,"datePublished":61,"encodingFormat":59,"isAccessibleForFree":62,"interactionStatistic":63},"DigitalDocument",{"name":9,"@type":55},"Person",{"url":40,"name":57,"@type":58},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-04","2026-09-01",true,{"@type":64,"interactionType":65,"userInteractionCount":21},"InteractionCounter",{"@type":66},"ViewAction",{"@type":68,"mainEntity":69},"FAQPage",[70,76,80],{"name":71,"@type":72,"acceptedAnswer":73},"What information must be included in the cover letter for the CTD to CTR transition?","Question",{"text":74,"@type":75},"It must include the description of changes across versions, a declaration on whether Part I documents are fully harmonised or consolidated across concerned Member States, and details on non-substantial changes, additional dossier documents, and approvals per Member State where applicable.","Answer",{"name":77,"@type":72,"acceptedAnswer":78},"How should sponsors indicate whether documents are fully harmonised or consolidated?",{"text":79,"@type":75},"For each Part I document (protocol, investigators’ brochure and/or IMPD), the cover letter should be completed by ticking or describing whether it is fully harmonised or consolidated across all concerned Member States, with consolidated Member State-specific aspects described in the table.",{"name":81,"@type":72,"acceptedAnswer":82},"When is an IMPD-Q only submission acceptable and what must be referenced?",{"text":83,"@type":75},"IMPD-Q only submission is possible for the initial transition application or, at the latest, when submitting the first SM application after transition. The cover letter must reference the relevant CTIS trial number when the IMPD-Q is submitted in another trial.","https://schema.org",{"og:url":50,"og:type":86,"og:title":14,"og:site_name":57,"og:description":15},"article",{"robots":88,"canonical":50},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":91},[92,97,102,107,112,117,122,125,130],{"id":93,"doc_module":11,"doc_module_name":45,"category_name":94,"show_sort_weight":95,"slug":96},11,"Presentations",90,"presentations",{"id":98,"doc_module":11,"doc_module_name":45,"category_name":99,"show_sort_weight":100,"slug":101},12,"Resumes",80,"resumes",{"id":103,"doc_module":11,"doc_module_name":45,"category_name":104,"show_sort_weight":105,"slug":106},14,"Invoices",70,"invoices",{"id":108,"doc_module":11,"doc_module_name":45,"category_name":109,"show_sort_weight":110,"slug":111},15,"Posters",60,"posters",{"id":113,"doc_module":11,"doc_module_name":45,"category_name":114,"show_sort_weight":115,"slug":116},16,"Social Media",50,"social-media",{"id":118,"doc_module":11,"doc_module_name":45,"category_name":119,"show_sort_weight":120,"slug":121},17,"Forms",40,"forms",{"id":12,"doc_module":11,"doc_module_name":45,"category_name":13,"show_sort_weight":123,"slug":124},30,"letters",{"id":126,"doc_module":11,"doc_module_name":45,"category_name":127,"show_sort_weight":128,"slug":129},21,"Paper Templates",5,"papers-templates",{"id":131,"doc_module":11,"doc_module_name":45,"category_name":132,"show_sort_weight":4,"slug":133},158,"General","general-158"]