{"id":65413,"date":"2024-03-20T10:31:40","date_gmt":"2024-03-20T15:31:40","guid":{"rendered":"https:\/\/www.crchudequebec.ulaval.ca\/platforms-and-services\/clinical-and-evaluative-research\/modes-operatoires-normalises-mon\/"},"modified":"2026-10-08T11:42:17","modified_gmt":"2026-10-08T15:42:17","slug":"standard-operating-procedures-sops","status":"publish","type":"page","link":"https:\/\/www.crchudequebec.ulaval.ca\/en\/platforms-and-services\/clinical-and-evaluative-research\/standard-operating-procedures-sops\/","title":{"rendered":"Standard Operating Procedures (SOPs)"},"content":{"rendered":"<section class=\"bg-white align wp-block-acf-content-with-left-sidebar\">\n    <div class=\"container\">\n    <div class=\"padd padd--bottom\">\n        <div class=\"wrap\">\n            <div class=\"flex md:flex-row flex-col md:gap-x-[8.3%] gap-x-3 md:gap-y-0 gap-y-8\">\n                <div class=\"sidebar md:w-1\/4 w-full flex flex-col gap-y-8\">\n                    \n                    \n                                                                        <div>\n                                                                    <h3 class=\"mb-0 text-16 font-bold\">Head of Clinical Research Service<\/h3>\n                                \n                                                                    <div class=\"mb-1\">\n                                        Genevi\u00e8ve Filion\n                                    <\/div>\n                                \n                                                                    <div class=\"mb-1\">\n                                                                                    \n                                            <a class=\"phone\" href=\"tel:+1\u202f418-525-4444, ext.\u202f48545\">+1\u202f418-525-4444, ext.\u202f48545<\/a>\n                                                                            <\/div>\n                                \n                                                       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<\/div>\n                                                    <div>\n                                                                    <h3 class=\"mb-0 text-16 font-bold\">Quality Assurance Manager<\/h3>\n                                \n                                                                    <div class=\"mb-1\">\n                                        J\u00e9r\u00e9my Baudet\n                                    <\/div>\n                                \n                                                                    <div class=\"mb-1\">\n                                                                                    \n                                            <a class=\"phone\" href=\"tel:+1\u202f418-525-4444, ext. 47970\">+1\u202f418-525-4444, ext. 47970<\/a>\n                                                                            <\/div>\n                                \n                                                                    <ul class=\"emails !mb-3\">\n                                                                                    <li class=\"overflow-hidden\">\n                                                <a class=\"group flex items-center\" href=\"mailto:jeremy.baudet@crchudequebec.ulaval.ca\" title=\"jeremy.baudet@crchudequebec.ulaval.ca\">\n                                                    <i class=\"fa-light fa-envelope shrink-0 group-hover:text-blue-500 duration-300\"><\/i>\n                                                    <span class=\"text-16 whitespace-nowrap overflow-hidden text-ellipsis group-hover:text-blue-500 duration-300\">jeremy.baudet@crchudequebec.ulaval.ca<\/span>\n                                                <\/a>\n                                            <\/li>\n                                                                            <\/ul>\n                                \n                                                            <\/div>\n                                                    <div>\n                                                                    <h3 class=\"mb-0 text-16 font-bold\">Team Leader and Quality Assurance Manager<\/h3>\n                                \n                                                                    <div class=\"mb-1\">\n                                        Pascale Levesque-Bernier\n                                    <\/div>\n                                \n                                                                    <div class=\"mb-1\">\n                                                                                    \n                                            <a class=\"phone\" href=\"tel:+1\u202f418-525-4444, ext. 52520\">+1\u202f418-525-4444, ext. 52520<\/a>\n                                                                            <\/div>\n                                \n                                                                    <ul class=\"emails !mb-3\">\n                                                                                    <li class=\"overflow-hidden\">\n                                                <a class=\"group flex items-center\" href=\"mailto:pascale.levesque-bernier@crchudequebec.ulaval.ca\" title=\"pascale.levesque-bernier@crchudequebec.ulaval.ca\">\n                                                    <i class=\"fa-light fa-envelope shrink-0 group-hover:text-blue-500 duration-300\"><\/i>\n                                                    <span class=\"text-16 whitespace-nowrap overflow-hidden text-ellipsis group-hover:text-blue-500 duration-300\">pascale.levesque-bernier@crchudequebec.ulaval.ca<\/span>\n                                                <\/a>\n                                            <\/li>\n                                                                            <\/ul>\n                                \n                                                            <\/div>\n                                            \n                    \n                    \n                    \n                                    <\/div>\n                <div class=\"main-content md:w-7\/12 w-full\">\n                    \n                    \n                                            <div class=\"content\">\n                            <div class=\"inner\">\n                                <p><span class=\"TextRun SCXW69042405 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW69042405 BCX0\">The CHU de<\/span><span class=\"NormalTextRun SCXW69042405 BCX0\">\u202f<\/span><span class=\"NormalTextRun SCXW69042405 BCX0\">Qu\u00e9bec-Universit\u00e9 Laval Research Center has developed standard operating procedures (SOPs) to ensure the quality of good clinical research practices. The SOPs <\/span><span class=\"NormalTextRun SCXW69042405 BCX0\">are intended<\/span><span class=\"NormalTextRun SCXW69042405 BCX0\"> for ALL PERSONNEL involved in a (clinical) research project in which the CHU de<\/span><span class=\"NormalTextRun SCXW69042405 BCX0\">\u202f<\/span><span class=\"NormalTextRun SCXW69042405 BCX0\">Qu\u00e9bec-Universit\u00e9 Laval, its auspices or institutions acting on its behalf are involved, whether it be a biobank, clinical trial, retrospective, prospective or fundamental research.<\/span><\/span><\/p>\n\n                            <\/div>\n                        <\/div>\n                    \n                    \n                    \n                    \n                                    <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n<\/section>\n\n\n<section class=\"bg-white align wp-block-acf-content-with-anchor\">\n    <div class=\"container\">\n        <div class=\"padd\">\n            <div class=\"wrap\">\n                \n                <div class=\"flex md:flex-row flex-col md:gap-x-[8.3%] md:gap-y-0 gap-y-8\">\n                    <div class=\"md:w-3\/12 w-full section-anchors\">\n                        <div class=\"inner\">\n                                                                                                <a href=\"#documentation\">Documentation<\/a>\n                                                                                                                                <a href=\"#evaluation\">Evaluation <\/a>\n                                                                                                                                <a href=\"#references\">References <\/a>\n                                                                                    <\/div>\n                    <\/div>\n                    <div class=\"md:w-8\/12 w-full\">\n                        <div class=\"flex flex-col md:gap-y-16 gap-y-8\">\n                                                            <div>\n                                                                            <h3 id=\"documentation\" class=\"mb-8 text-36\">Documentation<\/h3>\n                                                                                                                    <p><strong><span class=\"TextRun Highlight SCXW203937818 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun CommentStart CommentHighlightPipeClickedV2 CommentHighlightClicked SCXW203937818 BCX0\">Please note that the Standard Operating Procedures (SOPs) documents are only available in French, on the French Website. To access these documents, please select &#8220;Fran\u00e7ais&#8221; in the upper right corner of this page.<\/span><\/span><\/strong><\/p>\n<hr \/>\n\n                                                                            <\/div>\n                                                            <div>\n                                                                            <h3 id=\"evaluation\" class=\"mb-8 text-36\">Evaluation <\/h3>\n                                                                                                                    <p>A new version of the SOP training course is available on the ENA (Environnement Num\u00e9rique d\u2019Apprentissage) platform: <strong><a href=\"https:\/\/fcp.rtss.qc.ca\/course\/view.php?id=17935\" target=\"_blank\" rel=\"noopener\">Formation : Modes op\u00e9ratoires normalis\u00e9s (MON) \u2013 CHU de Qu\u00e9bec \u2013 Universit\u00e9 Laval (version avril 2\u2026<\/a><\/strong><\/p>\n<p>For more information on how to register for the training course, please consult the document entitled \u201c<span data-contrast=\"auto\">\u202f<\/span><a href=\"https:\/\/www.crchudequebec.ulaval.ca\/wp-content\/uploads\/2026\/04\/Inscription-a-une-formation-dans-ENA_01avril2026.pdf\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Inscription \u00e0 la formation MON dans ENA<\/span><span data-contrast=\"none\">\u202f<\/span><\/a>\u201d (\u201cRegistering for SOP training in ENA\u201d).<\/p>\n<p>If you have any questions, please contact Quality Assurance at <a href=\"mailto:rechclinique@crchudequebec.ulaval.ca\">rechclinique@crchudequebec.ulaval.ca<\/a><\/p>\n<hr \/>\n\n                                                                            <\/div>\n                                                            <div>\n                                                                            <h3 id=\"references\" class=\"mb-8 text-36\">References <\/h3>\n                                                                                                                    <p>Note: please refer to the various sections of the <span data-contrast=\"auto\"><a href=\"https:\/\/www.crchudequebec.ulaval.ca\/extranet\/plateforme-de-recherche-clinique-et-evaluative-boite-a-outils\/informations-institutionnelles\/\" target=\"_blank\" rel=\"noopener\">Toolbox<\/a><\/span> (Bo\u00eete \u00e0 outils) for any supporting documents not found here.<\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/www.chudequebec.ca\/patient\/formulaires\/formulaire-de-plaintes-ou-d-insatisfaction.aspx\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Making a complaint to the Complaints Commissioner<\/span><\/a><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/www.frq.gouv.qc.ca\/app\/uploads\/2021\/03\/standards_frsq_ethique_recherche_humain_2009.pdf\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Standards du FRQS sur l\u2019\u00e9thique de la recherche en sant\u00e9 humaine et l\u2019int\u00e9grit\u00e9<\/span><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/a><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/C.R.C.%2C_c._870\/index.html\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Health Canada Food and Drug Regulations (C.R.C., c.\u202f870)<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/ethics.gc.ca\/eng\/policy-politique_tcps2-eptc2_2022.html\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">TCPS2 2022<\/span><\/a><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/database.ich.org\/sites\/default\/files\/E6_R2_Addendum.pdf\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice\u202fE6(R2)<\/span><\/a><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><a href=\"https:\/\/www.crchudequebec.ulaval.ca\/wp-content\/uploads\/2026\/03\/ICH_E6R3_Step4_FinalGuideline_2025_0106.pdf\" target=\"_blank\" rel=\"noopener\">ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3)<\/a> <strong>(effective from April 1st 2026)<\/strong><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/good-clinical-practices\/guidance-documents\/guidance-drugs-clinical-trials-human-subjects-gui-0100\/document.html\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Guidance Document: Part C, Division\u202f5 of the Food and Drug Regulations \u201cDrugs for Clinical Trials Involving Human Subjects\u201d (GUI-0100) \/ August 20, 2019<\/span><\/a><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n\n                                                                            <\/div>\n                                                    <\/div>\n                    <\/div>\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Standard operating procedures (SOPs) developed by the CHU de\u202fQu\u00e9bec-Universit\u00e9 Laval Research Centre to ensure quality in terms of good clinical research practices. <\/p>\n","protected":false},"author":5,"featured_media":0,"parent":42183,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-65413","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Standard 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