[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-241082-105":53,"doc-detail-241082-en":126},{"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":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","research-project-change-log-version-1-action","Research Project Change Log - Version 1 - Action","","Research Project Change Log template designed to record every modification to research activities, including data updates, protocol changes, statistical analysis plans, and regulatory documents. Each change is captured with a unique ID, description, scientific or operational rationale, expected impact, approval decision, responsible owner, decision date, and current status. The log supports reproducibility, transparency, and audit readiness by enforcing sign-off before marking changes completed and by requiring stakeholder review for high-impact updates, with specific audit notes for regulatory references.",{"@graph":63,"@context":118},[64,80,101],{"@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-change-log-version-1-action/241082/",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-change-log-version-1-action/241082.png","ImageObject",442,249,{"name":88,"@type":89},"Himbo","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-11-03","2026-09-11",true,{"@type":98,"interactionType":99,"userInteractionCount":15},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What kinds of research updates must be logged in this change log?","Question",{"text":108,"@type":109},"All modifications to the research project must be logged here before implementation, including data changes, protocol updates, analysis plan revisions, and regulatory document changes.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How are change statuses defined and progressed?",{"text":113,"@type":109},"Statuses use a lifecycle legend: ✅ Completed (fully implemented and verified), 􀂉 In Progress, 􀂺 Under Review, 􀃃 Pending Review, and ⚪ Not Started.",{"name":115,"@type":106,"acceptedAnswer":116},"What additional requirements apply to high-impact and regulatory changes?",{"text":117,"@type":109},"High-impact changes require review by the Principal Investigator (PI) and documentation in meeting minutes. Regulatory changes (ICF, DTA, SAP) must reference the corresponding IRB or sponsor submission number in the Description field.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},241082,1789170127,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":15,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":76,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":125,"read_time":9},687197100911,"https://ap-avatar.wpscdn.com/avatar/a000239b6f1da00475?x-image-process=image/resize,m_fixed,w_180,h_180&k=1785132997149421697","Research Project Change Log  \nGenerated: 09 June 2026 | Project: [TBD] | Version: 1.0  \nOverview  \nThis template tracks all modifications to the research project to ensure reproducibility, transparency, and audit-readiness. Every change —whether to data, protocols, analysis plans, or regulatory documents —must be logged here before implementation.  \nChange Log Table  \n\n| Change ID | Description | Rationale | Impact | Decision | Owner | Date | Status |\n| --- | --- | --- | --- | --- | --- | --- | --- |\n| CHG- 001 | Clinical dataset\u003Cbr>v2 variable\u003Cbr>update —added\u003Cbr>BMI_category, removed\u003Cbr>deprecated weight_ raw | Align with updated WHO classification standards;\u003Cbr>legacy variable caused\u003Cbr>inconsistency across cohort\u003Cbr>sub-groups | Medium — rerun\u003Cbr>preprocessing pipeline; update data dictionary and codebook | Approved | Dr. A. Patel (Data Manager) | 2026-\u003Cbr>04-10 | ✅\u003Cbr>Completed |\n| CHG- 002 | Approval tracking workflow —\u003Cbr>integrate IRB\u003Cbr>amendment\u003Cbr>sign-off into project management system | Manual email\u003Cbr>based approvals caused version\u003Cbr>control gaps; centralised tracking reduces\u003Cbr>audit risk | Low —\u003Cbr>administrative\u003Cbr>process change; no data\u003Cbr>modification\u003Cbr>required | Approved | J. Okonkwo (Project Lead) | 2026-\u003Cbr>04-15 | 􀂉 In Progress |\n| CHG- 003 | Statistical analysis plan (SAP) v1 .2 —revised primary endpoint from 6-month to 12-month follow-up | Interim data\u003Cbr>suggested insufficient\u003Cbr>power at 6 months;\u003Cbr>extended follow\u003Cbr>up improveseffect-size\u003Cbr>detection | High —timeline\u003Cbr>extension ~3\u003Cbr>months; requires\u003Cbr>sponsor notification\u003Cbr>and protocol\u003Cbr>amendment | Pending\u003Cbr>Review | [TBD] —Biostatistics Lead | 2026-\u003Cbr>04-22 | 􀂺 Under Review |\n| CHG- 004 | Data transfer agreement (DTA) update — | Site C enrollment\u003Cbr>approved; | Medium —\u003Cbr>legal review required; | [TBD] | [TBD] —Regulatory Affairs | [TBD] | ⚪ Not\u003Cbr>Started |\n\n\n| Change ID | Description | Rationale | Impact | Decision | Owner | Date | Status |\n| --- | --- | --- | --- | --- | --- | --- | --- |\n|  | add secondary site (Site C) data sharing clause | existing DTA does not cover multi-site data pooling requirements | estimated 2-week turnaround |  |  |  |  |\n| CHG- 005 | Informed\u003Cbr>consent form\u003Cbr>(ICF) v3 —plain-language revision for\u003Cbr>readability (Flesch score ≥ 60) | Patient advisory board feedback\u003Cbr>indicated comprehension issues in v2; regulatory bestpractice\u003Cbr>mandate | Low — no\u003Cbr>scientific\u003Cbr>change; requires IRB\u003Cbr>re-approval before re\u003Cbr>consenting | Approved | M. Chen (Clinical Coordinator) | 2026-\u003Cbr>04-28 | ✅\u003Cbr>Completed |\n| CHG- 006 | [TBD] —placeholder for next scheduled change | [TBD] | [TBD] | [TBD] | [TBD] | [TBD] | ⚪ Not\u003Cbr>Started |\n\nStatus Legend  \n\n| Symbol | Status | Meaning |\n| --- | --- | --- |\n| ✅ | Completed | Change fully implemented and verified |\n| 􀂉 | In Progress | Change actively being implemented |\n| 􀂺 | Under Review | Change submitted; awaiting stakeholder review |\n| 􀃃 | Pending Review | Change drafted; not yet submitted |\n| ⚪ | Not Started | Change identified; implementation not begun |\n\nColumn Definitions  \n\n| Column | Definition |\n| --- | --- |\n| Change ID | Unique sequential identifier (format: CHG-NNN) |\n| Description | Concise statement of what changed and in which document/dataset |\n| Rationale | Scientific, regulatory, or operational justification for the change |\n| Impact | Scope and severity — Low / Medium / High —with downstream effects noted |\n| Decision | Approval outcome: Approved / Pending Review / Rejected / [TBD] |\n| Owner | Full name and role of the person responsible for implementing the change |\n| Date | ISO 8601 date of decision or implementation (YYYY-MM-DD) |\n\n\n| Column | Definition |\n| --- | --- |\n| Status | Current lifecycle state of the change |\n\n\n| Usage Instructions\u003Cbr>1. Add rows sequentially — use CHG-007 , CHG-008 …for each new change. |\n| --- |\n| 2. Complete all [TBD] fields before submitting a change for review. |\n| 3. Update Status as the change progresses through the workflow. |\n| 4.","cbCaidAJYXTEkuLT","https://ap.wps.com/l/cbCaidAJYXTEkuLT","pdf",164025,"English","# Overview\n# Change Log Table\n## Status Legend\n## Column Definitions\n# Usage Instructions\n# Audit Notes","[{\"question\":\"What kinds of research updates must be logged in this change log?\",\"answer\":\"All modifications to the research project must be logged here before implementation, including data changes, protocol updates, analysis plan revisions, and regulatory document changes.\"},{\"question\":\"How are change statuses defined and progressed?\",\"answer\":\"Statuses use a lifecycle legend: ✅ Completed (fully implemented and verified), 􀂉 In Progress, 􀂺 Under Review, 􀃃 Pending Review, and ⚪ Not Started.\"},{\"question\":\"What additional requirements apply to high-impact and regulatory changes?\",\"answer\":\"High-impact changes require review by the Principal Investigator (PI) and documentation in meeting minutes. Regulatory changes (ICF, DTA, SAP) must reference the corresponding IRB or sponsor submission number in the Description field.\"}]","Research Project Change Log - Version 1 - Action | PDF"]