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It centralizes essential study details, current status and progress, subject status counts, vendor access, critical pending items, and study-specific considerations. Checkboxes and free-text fields guide accurate completion, including N/A options where observational studies have fewer operational or regulatory requirements. Applies to coordinators, study managers, research assistants, principal investigators, and any research operations staff involved in handovers.",{"@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":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/research-project-handover-tool-version-01-sop-template/246308/",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/research-project-handover-tool-version-01-sop-template/246308.png","ImageObject",442,249,{"name":88,"@type":89},"Ivy","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-24","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",13,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the purpose of the Research Project Handover Tool?","Question",{"text":109,"@type":110},"It ensures a smooth and comprehensive transition between outgoing and incoming research staff by capturing essential study details, status updates, subject progress, vendor access, pending tasks, and study-specific considerations.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"Who should use this handover guidance and tool?",{"text":114,"@type":110},"Clinical Research Coordinators, Study Managers, and Research Assistants, as well as Principal Investigators and any staff involved in research operations and handovers.",{"name":116,"@type":107,"acceptedAnswer":117},"How should observational studies be handled in the tool?",{"text":118,"@type":110},"The form includes N/A options for study-specific applicability; observational studies can be marked as not applicable when justified due to fewer operational and regulatory requirements.","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},246308,1789234707,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":35,"category_name":36,"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":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":126,"read_time":73},549758252649,"https://ap-avatar.wpscdn.com/avatar/8000253669c5317157?_k=1778319167496531819","| Title:\u003Cbr>Research Study Handover Tool | Version Number: 01 | Effective Date:\u003Cbr>Dec 2024 | Page 1 of 6 |\n| --- | --- | --- | --- |\n\n\n| Revision History |  |  |\n| --- | --- | --- |\n| Version No. | Effective Date | Description |\n| V1 | 18APR2025 | Revised and expanded tool to accommodate observational studies, including clarifications and N/A options for study-specific applicability. |\n|  |  |  |\n\nPurpose:  \nThe Research Project Handover Tools is designed to ensure a smooth and comprehensive transition of responsibilities between outgoing and incoming research staff. It serves as a centralized summary of essential study details, status updates, subject progress, vendor access, pending task, and study-specific considerations.  \nThis tool promotes continuity, data integrity and regulatory compliance by capturing all critical operational elements during staff transitions.  \nScope and Responsibilities:  \nThis Standard Operating Guidance applies to Clinical Research Coordinators, Study Managers and Research Assistances as well as to Principal Investigators and any staff involved in research operations and handovers.  \nProcedures  \n1. Complete all sections with the most current and accurate information available at the time of handover.  \n2. Use the checkboxes and free-text field to indicate the current study status, pending tasks, and important contacts.  \n3. For each category (e.g. vendors, subject status, training records), indicate the relevant details and mark N/A when not applicable.  \n4. The outgoing staff member is responsible for initiating and filling in this tool, and the incoming staff member should review and confirm the information provided is clear and that all questions have been answered before singing and finalizing the tool.  \n5. Recognizing that observational studies often have fewer operational and regulatory requirements, the form includes “N/A” options, as such should be marked as not applicable when justified.  \n\n| Title:\u003Cbr>Research Project Handover Tool | Version\u003Cbr>Number:\u003C\\#> | Effective Date:\u003CDate> | Page 2 of 6 |\n| --- | --- | --- | --- |\n\nApplicability Across All Study Types  \nThis handover tool is suitable for all types of research studies, including:  \n• Interventional/Therapeutic Trials (e.g. drug/device trials)  \n• Observational Studies (e.g. chart reviews, longitudinal studies)  \nDocument Approval  \no Name and Title of Approver  \no Date in the format (MM/DD/YYYY)  \no Insert Name and Title below Signature  \nApproved By: Date:  \nInsert Name and Title  \n\n| 1. Handover Details |  |\n| --- | --- |\n| Date of Handover: |  |\n| Last Working Day: |  |\n| Name of Outgoing Study Coordinator: |  |\n| Name of Incoming Study Coordinator: | Signature: |\n\n2. Project Information  \n3. Project Status  \n\n| Site Initiation Visit (SIV) Date: |  / /  |  |  |  |\n| --- | --- | --- | --- | --- |\n| Enrollment Target: |  |  |  |  |\n|  |  |  |  |  |\n|  |  |  |  |  |\n| Current Study Phase: | □ Start-Up |  |  | □ Active (Enrolling) |\n|  | □ Active (Closed Enrollment) |  |  | □ Closing/Close-Out |\n| Enrollment Progress: Subject Status and Counts | Status |  |  | Number of Subjects |\n|  | □ In Screening |  |  |  |\n|  | □ Enrolled |  |  |  |\n|  | □ Completed |  |  |  |\n|  | □ Withdrawn |  |  |  |\n|  | □ Screen Failed |  |  |  |\n|  | □ Other  |  |  |  |\n| Next Scheduled Monitoring Visit (IMV), if applicable |  / /  N/A □ |  |  |  |\n| Has CRA Scheduled IP Review with Pharmacy for Next IMV?, If applicable | Yes □ No □ N/A □\u003Cbr>If No, request CRA to coordinate directly with the pharmacy |  |  |  |\n\n\n| Protocol Name/Number: |  |\n| --- | --- |\n| Study Type: | □ Observational\u003Cbr>□ Interventional/Therapeutic |\n| IRB of Record: | □ UCSD/Kuali Research\u003Cbr>□ Advarra\u003Cbr>□ WCGI\u003Cbr>□ Other  |\n| IRB Number (UCSD/RCHSD): | \\# |\n| Key Staff /Sponsor Contact(s):(include name, role, email address and other relevant details): | Clinical Research Associate (CRA), if applicable: |\n|  | Sponsor/Funder/PI Contact: |\n|  | Invoicing Contact, if applicable: |\n","cbCaivV1FkyI52Cw","https://ap.wps.com/l/cbCaivV1FkyI52Cw","pdf",223045,6,"English","# Purpose\n# Scope and Responsibilities\n# Procedures\n# Applicability Across All Study Types\n# Document Approval\n# 1. Handover Details\n## 2. Project Information\n## 3. Project Status\n## 4. Study Staff Contacts\n## 5. Vendors Access Details\n## 6. Critical Pending Items\n## 7. Subject-Related Activities\n## 8. Recurring Study Specific Meetings & Communication Channels","[{\"question\":\"What is the purpose of the Research Project Handover Tool?\",\"answer\":\"It ensures a smooth and comprehensive transition between outgoing and incoming research staff by capturing essential study details, status updates, subject progress, vendor access, pending tasks, and study-specific considerations.\"},{\"question\":\"Who should use this handover guidance and tool?\",\"answer\":\"Clinical Research Coordinators, Study Managers, and Research Assistants, as well as Principal Investigators and any staff involved in research operations and handovers.\"},{\"question\":\"How should observational studies be handled in the tool?\",\"answer\":\"The form includes N/A options for study-specific applicability; observational studies can be marked as not applicable when justified due to fewer operational and regulatory requirements.\"}]","Research Project Handover Tool - Version 01 - SOP template | PDF"]