[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-168893-en":3,"doc-seo-168893-105":30,"detail-sidebar-cat-1-en-105":91},{"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":29},168893,1374402968488,"Đào","https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0",1,17,"Forms","Clinical Risk Management Plan TEMPLATE - Introduction","Clinical Risk Management Plan (CRMP) outlines how a project team implements the Clinical Safety Management System, including how variations to the approved CRMS practices are documented. The plan defines control measures to ensure high-quality safety work, compliance with CSMS requirements, and alignment with programme-specific needs. It also establishes the context for clinical safety standards by describing the roles and expectations set by DCB0129 and DCB0160 across Health IT system manufacture, deployment, and use, including governance for updates when commitments change.","\u0003Clinical Risk Management Plan\u0004\nClinical Risk Management Plan TEMPLATE\nUpdates\nDocument Management\nRevision History\nReviewers\nThis document must be reviewed by the following people:\nApproved by\nThis document must be approved by the following people:\nRelated Documents\nThese documents provide additional information and are specifically referenced within this document.\nContents\n\u0013 TOC \\o \"1-2\" \\h \\z \u0014\u0013 HYPERLINK \\l \"_Toc490472093\" \u0014Introduction\t\u0013 PAGEREF _Toc490472093 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472094\" \u0014Purpose of Document\t\u0013 PAGEREF _Toc490472094 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472095\" \u0014Background to clinical safety standards and requirements\t\u0013 PAGEREF _Toc490472095 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472096\" \u0014DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems\t\u0013 PAGEREF _Toc490472096 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472097\" \u0014DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems\t\u0013 PAGEREF _Toc490472097 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472098\" \u0014Programme Overview & Clinical Safety\t\u0013 PAGEREF _Toc490472098 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472099\" \u0014Impact of DCB0129 and DCB0160 on Programme\t\u0013 PAGEREF _Toc490472099 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472100\" \u0014Clinical Risk Management File\t\u0013 PAGEREF _Toc490472100 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472101\" \u0014Programme Individual project areas and associated assurance approaches\t\u0013 PAGEREF _Toc490472101 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472102\" \u0014Resources / Personnel\t\u0013 PAGEREF _Toc490472102 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472103\" \u0014Clinical Risk Evaluation and Management\t\u0013 PAGEREF _Toc490472103 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc490472104\" \u0014Appendix – Risk Classification Matrix\t\u0013 PAGEREF _Toc490472104 \\h \u00149\u0015\u0015\n\u0015\n\u000f\nIntroduction\nPurpose of Document\nThe purpose of the Clinical Risk Management Plan (CRMP) is to define the implementation of, and any variation to, the Insert Organisation Name Clinical Safety Management System. It describes how the project team will conduct clinical risk management to ensure patient safety with respect to services provided and the interrelated and interactive activities that will occur to ensure that the project meets the requirements of DCB0129 and DCB0160\nIn fulfilling this purpose, any variation to the standard practices and procedures to be followed, as defined by the Clinical Risk Management System (CRMS), when performing the activities of the programme are documented here in this document.\nThis CRMP identifies the means by which the project shall be controlled to ensure that the safety work is of high quality, conforms to the requirements of the CSMS and any specific programme requirements.\nThis document will be updated when the plan changes in any way as to deviate from what has been committed to deliver.\nBackground to clinical safety standards and requirements\nInformation standards provide the mechanism for introducing requirements to the NHS, those with whom it commissions services and its IT system suppliers.  There are two Information Standards related to patient safety described below.  These Standards can be found at:\n\u0013 EMBED AcroExch.Document.DC \u0014\n\u0015\n\u0013 EMBED AcroExch.Document.DC \u0014\n\u0015\nDCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems\nThis standard sets clinical risk management standards for manufacturers of Health IT systems.  It requires the manufacturer to establish a structure within which clinical risks associated with the design and development of a new Health IT system or the modification of an existing system are properly managed.  It also ensures that outputs are clearly documented to provide evidence of compliance.  Compliance with the standard ensures that the manufacturer has instigated a best practice clinical safety programme during the manufacture of the health IT system.\nDCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems\nThis standard requires health organisations deploying and using new or modified ","cbCaiuUJn178f9zw","https://ap.wps.com/l/cbCaiuUJn178f9zw","docx",716649,12,"English","en",105,"# Introduction\n# Purpose of Document\n# Background to clinical safety standards and requirements\n# DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems\n# DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems\n# Programme Overview & Clinical Safety\n# Impact of DCB0129 and DCB0160 on Project\n# Clinical Risk Management File\n# Clinical Risk Evaluation and Management\n# Appendix – Risk Classification Matrix","[{\"question\":\"What is the purpose of the Clinical Risk Management Plan (CRMP)?\",\"answer\":\"It defines how the project team implements the Clinical Safety Management System and documents any variations to standard CRMS practices to ensure patient safety and compliance with CSMS and programme requirements.\"},{\"question\":\"How do DCB0129 and DCB0160 relate to clinical risk management?\",\"answer\":\"DCB0129 sets standards for manufacturers managing clinical risks in the design, development, or modification of Health IT systems, while DCB0160 sets requirements for health organisations to manage risks during deployment and use, with overlapping requirements.\"},{\"question\":\"When is the CRMP updated?\",\"answer\":\"The document is updated whenever the plan changes in any way that deviates from what was committed to deliver, with revised documentation agreed through clinical safety governance to ensure correct control.\"}]","Clinical Risk Management Plan TEMPLATE - 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