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The SOP sets expectations for controlled document handling, defines core training categories and relevant Good Clinical Practice requirements, and details how training records are created, updated, and reviewed annually by investigators or line managers. It also covers archiving responsibilities when staff leave roles.",{"@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":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/rgit-sop-024-training-record-maintenance-controlled-sop/243291/",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/rgit-sop-024-training-record-maintenance-controlled-sop/243291.png","ImageObject",442,249,{"name":88,"@type":89},"Xiajie","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-19","2026-09-12",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 is the purpose of RGIT SOP 024?","Question",{"text":109,"@type":110},"It describes the process and requirements, aligned with Good Clinical Practice, to maintain training record folders for RGIT staff and other research staff conducting Imperial College sponsored studies.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What is required when creating a training record file?",{"text":114,"@type":110},"Staff must create their own training record file including the items listed in Appendix One, while some documents may be filed separately in a central system.",{"name":116,"@type":107,"acceptedAnswer":117},"Who reviews and when should training records be updated?",{"text":118,"@type":110},"Training records should be reviewed annually by the Chief/Principal Investigator or line manager, including checks for completeness and potential training needs, and specific GCP certificate refresh cycles apply.","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},243291,1791538790,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"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":47,"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":140,"read_time":73},8814010472675,"https://avatar.qwps.com/avatar/WGlhamll","This is a controlled document.  \nThe master document is posted on the RGIT website and any print-off of this document will be  \nclassed as uncontrolled.  \nResearchers and their teams may print off this document for training and reference purposes but are responsible for regularly checking the RGIT website for more recent versions  \n\n| Maintaining Training Records |  |\n| --- | --- |\n| SOP Reference: RGIT_SOP_024 |  |\n| Version Number: 9.0 |  |\n| Effective Date: 14 Jun 2024 | Review by: 14 Jun 2027 |\n| Author: Agnese Zicari, Quality Assurance Facilitator |  |\n| Approved by: Keith Boland , Senior Clinical Trial Manager | Date: Keith Boland a0igt1t'0:a20ll'y04ig. d14by14K:it8:h16Boland\u003Cbr>|\n\n\n| Version | Date | Reason for Change |\n| --- | --- | --- |\n| Version 1.0 | 31 May 2007 |  |\n| Version 2.0 | 24 Jun 2008 | Annual review |\n| Version 3.0 | 08 Feb 2010 | Formation of Joint Research Office |\n| Version 4.0 | 14 Jul 2011 | Annual review |\n| Version 5.0 | 03 Dec 2012 | Annual review |\n| Version 6.0 | 18 Feb 2015 | Scheduled review |\n| Version 7.0 | 25 Oct 2017 | Scheduled review |\n| Version 8.0 | 19 Oct 2020 | Scheduled review\u003Cbr>Templates removed and administrative changes to SOPJRCO name change to RGIT. |\n| Version 9.0 | 14 Jun 2024 | 3 year SOP review |\n\nTABLE OF CONTENTS  \n1. PURPOSE ............................................................................................................ 3  \n2. INTRODUCTION .................................................................................................. 3  \n3. PROCEDURE....................................................................................................... 3  \n3.1. Creating a Training Record File................................................................................... 3  \n3.2. Updating a Training Record File .................................................................................. 3  \n3.3. Archiving a Training Record File ................................................................................. 4  \n4. REFERENCES ..................................................................................................... 4  \n5. APPENDICES ...................................................................................................... 5  \n1. PURPOSE  \nThis standard operating procedure (SOP) describes the process and requirements , as per good clinical practice (GCP) , to maintain the training record folders of staff within the RGIT and other research staff conducting Imperial College sponsored studies.  \n2. INTRODUCTION  \n‘ In the GxP environment, training commonly falls into the following categories: mandatory training; role-based/role-specific training; needs-directed training’ (RQA, 2015) . In clinical settings, the mandatory training requirements are defined by the EU Clinical Trials Directive 2001/20/EC (Art. 4 & 6) , EU Good Clinical Practice Directive 2005/28/EC (Art. 2) , and the CTR (2004) as well as its subsequent amendments, from which all the principles of Good Clinical Practice (GCP) stem from.  \nIn addition to the above, the training of all staff members who work in healthcare-related-research should be tailored differently depending on their role, the level of contact with patients/serviceusers, nature of their work, and level of responsibility. More precisely , all training of research staff must be carried out also in conjunction with the requirements by the associated NHS Trusts and other policies and procedures by the Imperial College of London and/or Imperial College Healthcare NHS Trust.  \nIn light of the above, all staff working in social or healthcare research must ensure that they are familiar with the requirements of Good Clinical Practice and that they maintain their own training record folders, so that all members of the study team stay ‘qualified by education, training and experience to perform his or her respective task(s)’ throughout the course of the research study (ICH GCP E6 R2 , 2.8) .  \n3. PROCEDURE  \n","cbCaie8CMAimMarg","https://ap.wps.com/l/cbCaie8CMAimMarg","pdf",264555,"English","# PURPOSE\n# INTRODUCTION\n# PROCEDURE\n## Creating a Training Record File\n## Updating a Training Record File\n## Archiving a Training Record File\n# REFERENCES\n# APPENDICES","[{\"question\":\"What is the purpose of RGIT SOP 024?\",\"answer\":\"It describes the process and requirements, aligned with Good Clinical Practice, to maintain training record folders for RGIT staff and other research staff conducting Imperial College sponsored studies.\"},{\"question\":\"What is required when creating a training record file?\",\"answer\":\"Staff must create their own training record file including the items listed in Appendix One, while some documents may be filed separately in a central system.\"},{\"question\":\"Who reviews and when should training records be updated?\",\"answer\":\"Training records should be reviewed annually by the Chief/Principal Investigator or line manager, including checks for completeness and potential training needs, and specific GCP certificate refresh cycles apply.\"}]","RGIT SOP 024 - Training Record Maintenance - Controlled SOP | PDF",1789202279]