{"id":32636,"date":"2023-09-18T12:25:26","date_gmt":"2023-09-18T09:25:26","guid":{"rendered":"https:\/\/crg.global\/?p=32636"},"modified":"2023-09-28T12:25:53","modified_gmt":"2023-09-28T09:25:53","slug":"risk-assessment-as-part-of-quality-risk-management","status":"publish","type":"post","link":"https:\/\/crg.global\/uk\/risk-assessment-as-part-of-quality-risk-management\/","title":{"rendered":"Risk Assessment as part of Quality Risk Management"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"32636\" class=\"elementor elementor-32636\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4bd248d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4bd248d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7472c24\" data-id=\"7472c24\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eb36dbc elementor-widget elementor-widget-image\" data-id=\"eb36dbc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"563\" height=\"338\" src=\"https:\/\/crg.global\/wp-content\/uploads\/2023\/09\/InfoCRG_article_11.jpeg\" class=\"attachment-large size-large wp-image-32638\" alt=\"\" srcset=\"https:\/\/crg.global\/wp-content\/uploads\/2023\/09\/InfoCRG_article_11.jpeg 563w, https:\/\/crg.global\/wp-content\/uploads\/2023\/09\/InfoCRG_article_11-300x180.jpeg 300w\" sizes=\"(max-width: 563px) 100vw, 563px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4ab54a8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4ab54a8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5801500\" data-id=\"5801500\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c2fcb65 elementor-widget elementor-widget-text-editor\" data-id=\"c2fcb65\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3 id=\"ember34\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Overview<\/strong><\/h3><p id=\"ember35\" class=\"ember-view reader-content-blocks__paragraph\">Quality Risk Management (QRM) is an integral part of the corporate Quality Management System. Effective QRM is fundamental to ensuring the protection of human Subjects participating in Clinical Trials and fundamental to reliability of Clinical Trial results.<\/p><p id=\"ember36\" class=\"ember-view reader-content-blocks__paragraph\">QRM helps to:<\/p><ul><li>efficiently manage business operations<\/li><li>preserve the Resources that would otherwise be consumed on corrective actions and rework<\/li><li>avoid disruptions to delivering the business objectives.<\/li><\/ul><h3 id=\"ember38\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Aim<\/strong><\/h3><p id=\"ember39\" class=\"ember-view reader-content-blocks__paragraph\">This article aims to briefly introduce the risk assessment process as an essential part of successful QRM.<\/p><h3 id=\"ember40\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Process<\/strong><\/h3><p id=\"ember41\" class=\"ember-view reader-content-blocks__paragraph\">General guidance on risk management exists from multiple sources. As a discipline, risk management is described in academic settings, in other industries, and through standards. Commonly referenced quality standards such as ICH Q9, International Organisation for Standardisation (ISO) 31000, and ICH E6 provide different perspectives and scopes in risk management best practices.<\/p><p id=\"ember42\" class=\"ember-view reader-content-blocks__paragraph\">Risk Assessment is a systematic process of organising information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards<\/p><p id=\"ember43\" class=\"ember-view reader-content-blocks__paragraph\">It is commonly understood that\u00a0<em>risk<\/em>\u00a0is defined as the combination of the probability of occurrence of\u00a0<em>harm<\/em>\u00a0and the\u00a0<em>severity<\/em>\u00a0of that harm.<\/p><p id=\"ember44\" class=\"ember-view reader-content-blocks__paragraph\">As an aid to clearly defining the risk(s) for risk assessment purposes, four fundamental questions are used at CRG:<\/p><ol><li>What might go wrong?<\/li><li>What is the probability (<em>likelihood<\/em>) it will go wrong?<\/li><li>What are the consequences (<em>severity<\/em>\u00a0or\u00a0<em>impact<\/em>)?<\/li><li>How easily the issue can be detected (<em>detectability<\/em>)?<\/li><\/ol><p id=\"ember46\" class=\"ember-view reader-content-blocks__paragraph\">Risk assessment helps to understand risks, their causes, consequences, probabilities, and ability to detect them with enough time for effective mitigation, either with existing controls or with launching contingency plan(s).<\/p><p id=\"ember47\" class=\"ember-view reader-content-blocks__paragraph\">The purpose of risk assessment is to provide information and analysis to make informed decisions.<\/p><h3 id=\"ember48\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Hazard identification<\/strong><\/h3><p id=\"ember49\" class=\"ember-view reader-content-blocks__paragraph\">Hazard identification is a systematic use of information to identify hazards referring to the risk question or problem description. Information can include historical data, theoretical analysis, informed opinions, and the concerns of stakeholders. Hazard identification addresses the \u201cWhat might go wrong?\u201d question, including identifying the possible consequences.<\/p><p id=\"ember50\" class=\"ember-view reader-content-blocks__paragraph\">In Clinical Trials CRG Project Team focuses on participating Subjects\u2019 safety and rights, data quality and reliability, overall study integrity including compliance with applicable laws and regulations, study timelines and costs.<\/p><p id=\"ember51\" class=\"ember-view reader-content-blocks__paragraph\">The above-mentioned Subjects\u2019 safety and rights, data quality and reliability are often referred as\u00a0<em>critical data and processes<\/em>.<\/p><p id=\"ember52\" class=\"ember-view reader-content-blocks__paragraph\">The risk to participating Subjects\u2019 safety is considered as the increased risk arising from the clinical research activity as opposed to the baseline level of risk arising from normal (routine) clinical practice.<\/p><p id=\"ember53\" class=\"ember-view reader-content-blocks__paragraph\">The following Risk Sources should be considered in Clinical Trials (non-exhaustive list):<\/p><ul><li><strong>Therapeutic indication<\/strong>\u00a0and consequently the type and number of Adverse Events and Serious Adverse Events per Subject, severity of disease and its prognosis, ease, or difficulty to find, enroll and retain Subjects for the duration defined in the study protocol, possible comorbidities that may affect recruitment, incidence and prevalence of the disease, disease seasonal patterns, etc.<\/li><li><strong>Clinical Trial Protocol<\/strong>, namely, its complexity, fit to the country-specific healthcare environment, number of visits, number of procedures per visit, the length of follow-up, comparators or standard of care requirements, equipment expected to be in place, experience in working with the equipment, central and local lab involvement, etc.<\/li><li><strong>Subject population<\/strong>, such as recruiting in-patients versus out-patients, vulnerable Subjects\u2019 populations, typical Subjects\u2019 profiles, etc.<\/li><li><strong>Geography<\/strong>, e.g., countries with a high Clinical Trial experience versus those with a limited experience, distances (thus, travel costs and inconveniences) of participants to get to Clinical Trial Site(s), normal (routine) clinical practice and standard of care in each participating country, logistics of supplies, etc.<\/li><li><strong>Investigators<\/strong>, namely, their interest, qualifications, location, cooperativeness, time limitations, importance (Key Opinion Leaders), business hours and availability, commitment for the whole study duration, teams, and back-ups, etc.<\/li><li><strong>Data collection and reliability<\/strong>, e.g., type of the Case Report Forms, monitoring strategy (on-site, remote, centralised, combined), Source Data Verification percentage, data critical for statistical analysis and adequate source data verification decision, etc.<\/li><li><strong>Investigational Medicinal Product \/ Medical Device<\/strong>, namely, the phase of development, established safety profile, potential Regulatory limitations to obtain approvals, required study reporting, specific instructions related to study drug \/ device handling, etc.\u00a0<\/li><li><strong>General study set-up<\/strong>, e.g., the number of Third-Party Vendors, logistics, timelines, agreed and documented delegated roles and responsibilities split between CRG and involved External Parties, collaboration model, clear definition of the scope, agreed risk-acceptance criteria, personnel availability, and qualifications, etc.<\/li><li><strong>Timelines and budget<\/strong>, e.g., whether the timelines are realistic and supported by available intelligence data, whether the budget is sufficient to cover the study costs, etc.<\/li><\/ul><h3 id=\"ember55\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Risk analysis<\/strong><\/h3><p id=\"ember56\" class=\"ember-view reader-content-blocks__paragraph\">Risk analysis is the estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms. The ability to detect the harm (detectability) also factors in the estimation of risk.<\/p><p id=\"ember57\" class=\"ember-view reader-content-blocks__paragraph\">Root cause analysis could be used to\u00a0<em>retrospectively<\/em>\u00a0identify the root causes of failure. Primary and secondary causes may be identified using various methodologies (e.g., Five Why\u2019s method). This methodology is recommended to analyse audit findings and issues that have occurred previously.<\/p><p id=\"ember58\" class=\"ember-view reader-content-blocks__paragraph\">Failure Modes and Effects Analysis (FMEA), could be used to\u00a0<em>prospectively<\/em>\u00a0analyse potential failures and associated causes, prioritise risks depending on their impact, probability, and detectability, and decide on measures to reduce the risks. The Risk Priority Number (RPN) used in FMEA indicates the attention the QRM team should pay to each risk; the higher RPN, the higher attention and need to treat the risk.<\/p><p id=\"ember59\" class=\"ember-view reader-content-blocks__paragraph\">The use of Lessons Learned is important in Risk analysis.<\/p><h3 id=\"ember60\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Risk evaluation<\/strong><\/h3><p id=\"ember61\" class=\"ember-view reader-content-blocks__paragraph\">Risk evaluation compares the identified and analysed risk against given risk criteria. Risk evaluations consider the strength of evidence for all four of the fundamental questions defined above. In doing an effective risk assessment, the robustness of the data set is important because it determines the quality of the output. Revealing assumptions and reasonable sources of uncertainty will enhance confidence in this output and\/or help identify its limitations.<\/p><p id=\"ember62\" class=\"ember-view reader-content-blocks__paragraph\">Uncertainty is due to a combination of incomplete knowledge about a process and its expected or unexpected variability. Typical sources of uncertainty include gaps in knowledge, gaps in process understanding, sources of harm (e.g., failure modes of a process, sources of variability), and probability of detection of problems.<\/p><p id=\"ember63\" class=\"ember-view reader-content-blocks__paragraph\">The output of a risk assessment is either a quantitative estimate of risk or a qualitative description of a range of risk. When risk is expressed quantitatively, a numerical probability is used. Alternatively, risk can be expressed using qualitative descriptors, such as \u201chigh\u201d, \u201cmedium\u201d, or \u201clow\u201d, which should be defined in as much detail as possible.<\/p><h3 id=\"ember64\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Carpathian Research Group capabilities<\/strong><\/h3><p id=\"ember65\" class=\"ember-view reader-content-blocks__paragraph\">CRG as a CRO promotes and encourages all of its staff to exercise \u2018\u2018risk-based thinking\u201d in execution of their job duties, so risks to quality could be proactively identified and prevented. We have extensive experience performing risk assessment in Clinical Trials and can greatly assist Sponsors in proper risk assessments for the benefit of smooth execution of Clinical Trials.<\/p><p id=\"ember66\" class=\"ember-view reader-content-blocks__paragraph\">Information on all other Clinical Trial services that we provide could be found at\u00a0<a href=\"https:\/\/crg.global\/uk\/\">www.crg.global<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Overview Quality Risk Management (QRM) is an integral part of the corporate Quality Management System. Effective QRM is fundamental to ensuring the protection of human Subjects participating in Clinical Trials and fundamental to reliability of Clinical Trial results. QRM helps to: efficiently manage business operations preserve the Resources that would otherwise be consumed on corrective [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"off","ocean_gallery_id":[],"footnotes":""},"categories":[1],"tags":[],"class_list":["post-32636","post","type-post","status-publish","format-standard","hentry","category-infocrg","entry"],"_links":{"self":[{"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/posts\/32636","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/comments?post=32636"}],"version-history":[{"count":4,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/posts\/32636\/revisions"}],"predecessor-version":[{"id":32641,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/posts\/32636\/revisions\/32641"}],"wp:attachment":[{"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/media?parent=32636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/categories?post=32636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/tags?post=32636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}