[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-167190-en":3,"doc-seo-167190-105":30,"detail-sidebar-cat-1-en-105":92},{"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":11,"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},167190,549758252649,"Ivy","https://ap-avatar.wpscdn.com/avatar/8000253669c5317157?_k=1778319167496531819",1,17,"Forms","JRMO Research Protocol for MHRA Regulated Studies - Protocol Template","JRMO research protocol template for MHRA-regulated studies in the UK, designed to structure study documentation for Joint Research Management Office review. Includes guidance to replace green template text with trial-specific content, insert “n/a” where sections do not apply, and define study titles, objectives, endpoints, and design rationale. Provides sections to capture sponsor and contact information, study conduct elements, consent procedures, risk and participant considerations, and detailed content prompts for consistent submission and administrative clarity.","JRMO Research Protocol for\nMHRA Regulated Studies\nGeneral NOTE: Green text is template text or guidance and should be removed and replaced with trial specific text. Black text should not be altered or removed. Please insert “n/a” if a section is not applicable to your protocol. This enables the Joint Research management Office (JRMO) team to see you have considered all sections. As part of the review these will be removed.\nThis protocol is written based on a UK based study- Alterations can be made to specific words ( REC to ethical committee for example) when used for a multi country studies.\nFull Title \t\u003Cfull title of study>\n\u003CChoose a descriptive study title that includes phase (e.g. phase I, phase II, etc.), design (e.g. randomised, double-blind, placebo-controlled, etc.), the investigational drug / device / intervention, and target disease(s). It should be immediately evident what the study is investigating and on whom to allow rapid judgment of relevance>\nShort Title\t\u003Cshort title of study>\n\u003CProvide a summary of the long title, using a short title or acronym. The short title is used on information sheets and consent forms for research participants. The short title should be sufficiently detailed to ensure it is clear to participants what the research is about in lay language>\n\u003CBefore choosing an acronym (instead of a short title), consider:\nWhether any studies already exist with the same acronym (search the internet and check with the JRMO).\nWhether the same acronym is used by regulators, finance, or governance teams.\nWhether the acronym causes offence, particularly if the study is international.>\n\u003CFor follow-up studies it is discouraged to use the same titles (e.g. Banana and then Banana II) to ensure studies easily distinguished from other Research Ethics Committee (REC) approved studies, thereby avoiding administrative errors during the study management.>\n\u003CIf acronyms are used the full title should explain them. The proposed acronym should not drive the long title.>\nSponsor\t\u003CDelete as applicable>\nBarts Health NHS Trust\nOR\nQueen Mary University of London\nContact person:\nDr Mays Jawad\nGovernance Operations Manager\nJoint Research Management Office\nMile End Road\nLondon E1 4NS\nPhone: +44 (0) 20 7882 7275/6574\nEmail: \u0013 HYPERLINK \"mailto:research.governance@qmul.ac.uk\" \u0014research.governance@qmul.ac.uk\u0015\nIRAS Number\t\u003CIRAS number>\nEudraCT Number\t\u003CEudraCT number>\nSponsors REC Reference\t\u003CREC Reference number>\nChief Investigator\t\u003CChief Investigator title and name >\n\u003CChief Investigator job title>\n\u003CChief Investigator postal address>\n\u003CChief Investigator telephone number>\n\u003CChief Investigator email address>\n\u000f\nStudy Contacts\n\u003CInclude phone, email, and fax numbers of all the key study contacts. Use shared/ study specific email addresses where possible>\nList of laboratories\t\u003Cname of laboratory>\n\u003CName of head of laboratory>\n\u003CPostal address of laboratory>\n\u003CTelephone number of laboratory>\n\u003CEmail address of main contact at laboratory>\n\u003CREPEAT FOR EACH LABORATORY>\n\u003C\nList of central facilities\t\u003CName of central facility>\n\u003CName of head of central facility>\n\u003CPostal address of central facility>\n\u003CTelephone number of central facility>\n\u003CEmail address of main contact at central facility>\n\u003CREPEAT FOR EACH CENTRAL FACILITY>\n\u000f\nContents\n\u0003Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc61875148\" \u0014I.\tContents\t\u0013 PAGEREF _Toc61875148 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc61875149\" \u0014II. Glossary of terms and abbreviations\t\u0013 PAGEREF _Toc61875149 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc61875150\" \u0014III. Signature page\t\u0013 PAGEREF _Toc61875150 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc61875151\" \u0014IV. Synopsis\t\u0013 PAGEREF _Toc61875151 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc61875152\" \u00141.0 Introduction\t\u0013 PAGEREF _Toc61875152 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc61875153\" \u00141.1 Background\t\u0013 PAGEREF _Toc61875153 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc61875154\" \u00141.2 Rationale for study design\t\u0013 PAGEREF _Toc61875154 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc61875155\" \u00141.3 Assessment and management of risk\t\u0013 PAGEREF _Toc61875155 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l ","cbCaik19TuceuiKh","https://ap.wps.com/l/cbCaik19TuceuiKh","docx",401858,63,"English","en",105,"# Introduction\n## Background\n## Rationale for study design\n## Assessment and management of risk\n# Trial objectives\n## Primary objective(s)\n## Secondary objective(s)\n## Endpoints\n## Study design\n# Patient evaluability and replacement\n## Target accrual\n## Participant identification and recruitment\n# Informed consent procedures\n## Vulnerable participant considerations\n## Writing, reading, and translation considerations\n## Participants lacking capacity\n## Minors\n# Participant allocation\n# Participant eligibility criteria\n## Inclusion criteria\n## Exclusion criteria","[{\"question\":\"How should green template text be handled in the protocol?\",\"answer\":\"Green text is template guidance and should be removed and replaced with trial-specific wording. Black text should not be altered or removed during preparation.\"},{\"question\":\"What should be inserted when a protocol section is not applicable?\",\"answer\":\"Use “n/a” for sections that do not apply, so the JRMO team can confirm that all areas were considered. These “n/a” entries will be removed during review.\"},{\"question\":\"What information is expected in the study title and short title?\",\"answer\":\"The full title should clearly state the phase, design, intervention (drug/device), and target disease(s). The short title should summarize the full title in plain language for participants and is used in information sheets and consent forms.\"}]","JRMO Research Protocol for MHRA Regulated Studies - Protocol Template | DOCX",1788210063,22,{"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":87,"head_meta":89,"extra_data":91,"updated_unix":28},"jrmo-research-protocol-for-mhra-regulated-studies-protocol-template","",{"@graph":36,"@context":86},[37,54,69],{"@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/forms/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/jrmo-research-protocol-for-mhra-regulated-studies-protocol-template/167190/",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","2026-09-02","2026-08-31",true,{"@type":66,"interactionType":67,"userInteractionCount":11},"InteractionCounter",{"@type":68},"ViewAction",{"@type":70,"mainEntity":71},"FAQPage",[72,78,82],{"name":73,"@type":74,"acceptedAnswer":75},"How should green template text be handled in the protocol?","Question",{"text":76,"@type":77},"Green text is template guidance and should be removed and replaced with trial-specific wording. Black text should not be altered or removed during preparation.","Answer",{"name":79,"@type":74,"acceptedAnswer":80},"What should be inserted when a protocol section is not applicable?",{"text":81,"@type":77},"Use “n/a” for sections that do not apply, so the JRMO team can confirm that all areas were considered. These “n/a” entries will be removed during review.",{"name":83,"@type":74,"acceptedAnswer":84},"What information is expected in the study title and short title?",{"text":85,"@type":77},"The full title should clearly state the phase, design, intervention (drug/device), and target disease(s). 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