{"id":65467,"date":"2024-06-18T10:00:26","date_gmt":"2024-06-18T14:00:26","guid":{"rendered":"https:\/\/www.crchudequebec.ulaval.ca\/platforms-and-services\/clinical-and-evaluative-research\/archivage-des-projets-de-recherche\/"},"modified":"2025-05-26T12:02:41","modified_gmt":"2025-05-26T16:02:41","slug":"research-projects-archiving","status":"publish","type":"page","link":"https:\/\/www.crchudequebec.ulaval.ca\/en\/platforms-and-services\/clinical-and-evaluative-research\/research-projects-archiving\/","title":{"rendered":"Research Projects Archiving"},"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. 48545 \">+1\u202f418-525-4444, ext. 48545 <\/a>\n                                                                            <\/div>\n                                \n                                                                    <ul class=\"emails !mb-3\">\n                                                                                    <li class=\"overflow-hidden\">\n                                                <a class=\"group flex items-center\" href=\"mailto:genevieve.filion@crchudequebec.ulaval.ca\" title=\"genevieve.filion@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\">genevieve.filion@crchudequebec.ulaval.ca<\/span>\n                                                <\/a>\n                                            <\/li>\n                                                                            <\/ul>\n                                \n                                                            <\/div>\n                                                    <div>\n                                                                    <h3 class=\"mb-0 text-16 font-bold\">Directive: Archiving of a Clinical Research Project (Archiving) <\/h3>\n                                \n                                                                    <div class=\"mb-1\">\n                                        Mary-Ann Desrosiers, Administrative Assistant &#8211; Research document management and archiving\n                                    <\/div>\n                                \n                                                                    <div class=\"mb-1\">\n                                                                                    \n                                            <a class=\"phone\" href=\"tel:+1\u202f418-525-4444, ext. 46150 \">+1\u202f418-525-4444, ext. 46150 <\/a>\n                                                                            <\/div>\n                                \n                                                                    <ul class=\"emails !mb-3\">\n                                                                                    <li class=\"overflow-hidden\">\n                                                <a class=\"group flex items-center\" href=\"mailto:directive.archivage@crchudequebec.ulaval.ca\" title=\"directive.archivage@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\">directive.archivage@crchudequebec.ulaval.ca<\/span>\n                                                <\/a>\n                                            <\/li>\n                                                                            <\/ul>\n                                \n                                                            <\/div>\n                                                    <div>\n                                                                    <h3 class=\"mb-0 text-16 font-bold\">Directive: Archiving of a Clinical Research Project (Archiving) <\/h3>\n                                \n                                                                    <div class=\"mb-1\">\n                                        Am\u00e9lie Pelletier, Administrative Assistant\n                                    <\/div>\n                                \n                                                                    <div class=\"mb-1\">\n                                                                                    \n                                            <a class=\"phone\" href=\"tel:+1\u202f418-525-4444, ext. 46250\">+1\u202f418-525-4444, ext. 46250<\/a>\n                                                                            <\/div>\n                                \n                                                                    <ul class=\"emails !mb-3\">\n                                                                                    <li class=\"overflow-hidden\">\n                                                <a class=\"group flex items-center\" href=\"mailto:directive.archivage@crchudequebec.ulaval.ca\" title=\"directive.archivage@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\">directive.archivage@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><i><span data-contrast=\"auto\">Please note: for all matters relating to medical archives (medical records), please contact the Medical Archives team at the following address: <\/span><\/i><a href=\"mailto:archivesrecherche@chudequebec.ca\"><i><span data-contrast=\"none\">archivesrecherche@chudequebec.ca<\/span><\/i><\/a><i><span data-contrast=\"auto\">.<\/span><\/i><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The CHU de\u202fQu\u00e9bec-Universit\u00e9 Laval Research Centre Management (DCRCHU, for <\/span><i><span data-contrast=\"auto\">Direction du Centre de recherche du CHU de Qu\u00e9bec-Universit\u00e9 Laval<\/span><\/i><span data-contrast=\"auto\">) offers a secure electronic archiving environment, administered by the Clinical and Evaluative Research Platform (PRCE, for <\/span><i><span data-contrast=\"auto\">Plateforme de recherche clinique et \u00e9valuative<\/span><\/i><span data-contrast=\"auto\">).<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The PRCE offers its customers a high-quality electronic archiving service, conducted in its up-to-date digitization stations, in compliance with an internal validation process. PRCE conducts its role and responsibilities in such a way as to provide an efficient service and simplified application logistics for the parties involved. The document digitization process is also entirely managed and conducted by the PRCE.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">It is the responsibility of the principal investigator or investigator-in-charge, the sponsor, and the team whose project has been authorized at the institution to be aware of the procedures for archiving the project. To this end, the storage of trial documents must be planned from the start of the study by the partner or the sponsor researcher, to ensure that the financial and human resources are available and planned for, and to comply with regulatory requirements.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">It is the responsibility of the clinical trial principal investigator and his\/her team to prepare the documents to be archived so that they are legible, intact, and complete, and to ensure that the originals to be retained are retained. In addition, they must ensure that the documentation given to the PRCE team is first purged and prepared in accordance with the good practices detailed in the following document.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The Principal Investigator is also responsible for the costs associated with the electronic archiving of his\/her clinical research project documents, where applicable.<\/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=\"#administrative-directive-of-the-chu-de-quebec-universite-laval-research-centre-archiving-of-a-clinical-research-project\">Administrative Directive of the CHU de\u202fQu\u00e9bec-Universit\u00e9 Laval Research Centre: Archiving of a Clinical Research Project<\/a>\n                                                                                                                                <a href=\"#price-list\">Price List <\/a>\n                                                                                                                                <a href=\"#forms-and-resources\">Forms and Resources<\/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=\"administrative-directive-of-the-chu-de-quebec-universite-laval-research-centre-archiving-of-a-clinical-research-project\" class=\"mb-8 text-36\">Administrative Directive of the CHU de\u202fQu\u00e9bec-Universit\u00e9 Laval Research Centre: Archiving of a Clinical Research Project<\/h3>\n                                                                                                                    <p>(Directive administrative du Centre de recherche du CHU de Qu\u00e9bec-Universit\u00e9 Laval\u202f: Archivage d\u2019un projet de recherche clinique)<\/p>\n<p><i><span data-contrast=\"auto\">Note: this document can be found in the \u201cStudy closure and archiving\u201d (\u201cFermeture d\u2019\u00e9tudes et archivage\u201d) section of the Toolbox (Bo\u00eete \u00e0 outils).<\/span><\/i><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In recent years, efforts have been made to identify and document the challenges involved in preserving and managing documents relating to a clinical research project when it closes.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">A work team made up of members of the Clinical and Evaluative Research Platform (PRCE, <\/span><i><span data-contrast=\"auto\">Plateforme de recherche clinique et \u00e9valuative<\/span><\/i><span data-contrast=\"auto\">) and managers from the Financial Resources and Legal Services Departments and the Research Centre Management proposed a guideline to clarify and standardize the practices surrounding this neglected but important stage in the life of a project.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Particular attention to the financial aspect in your future research budgets is essential to plan for the costs inherent in taking care of the archiving of your research records.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For any clinical research project whose status has been authorized since 1 April 2018 and which has private or academic funding, the Directive applies when at least one of the following situations arises:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"31\" 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\"><span data-contrast=\"auto\">A retention period for study documents is specified in a contractual agreement ratified by the CHU de\u202fQu\u00e9bec-Universit\u00e9 Laval, a research protocol, or any other official study document; or<\/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=\"31\" 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\"><span data-contrast=\"auto\">A retention period is specified in the research protocol or in any other official study document required to obtain ethical approval; or<\/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=\"31\" 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\"><span data-contrast=\"auto\">A retention period and retention conditions are required by applicable laws.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Although the Directive applies to non-funded projects and those conducted by residents, you should know that the archiving services offered by PRCE are free of charge for these specific cases.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Please do not hesitate to <\/span><a href=\"mailto:directive.archivage@crchudequebec.ulaval.ca\"><span data-contrast=\"none\">contact us<\/span><\/a><span data-contrast=\"auto\"> if you have any questions about its application in your respective sectors.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n\n                                                                            <\/div>\n                                                            <div>\n                                                                            <h3 id=\"price-list\" class=\"mb-8 text-36\">Price List <\/h3>\n                                                                                                                    <p>The price list can be found in appendix\u202f1 of the document Administrative Directive of the CHU de\u202fQu\u00e9bec-Universit\u00e9 Laval Research Centre: Archiving of a Clinical Research Project (updated version with indexed price list effective April 1 of each year). This document can be found in the \u201cStudy Closure and Archiving\u201d (\u201cFermeture d\u2019\u00e9tudes et archivage\u201d) section of the <span class=\"TextRun SCXW102457040 BCX0\" lang=\"FR-CA\" xml:lang=\"FR-CA\" 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\"><span class=\"NormalTextRun CommentStart CommentHighlightPipeRestV2 CommentHighlightRest SCXW102457040 BCX0\">Toolbox<\/span><\/a> <\/span>(Bo\u00eete \u00e0 outils).<\/p>\n\n                                                                            <\/div>\n                                                            <div>\n                                                                            <h3 id=\"forms-and-resources\" class=\"mb-8 text-36\">Forms and Resources<\/h3>\n                                                                                                                    <p><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW212183142 BCX0\">Various documents are available in the <\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">\u201c<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">Study Closure and Archiving<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">\u201d<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\"> (<\/span><\/span><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW212183142 BCX0\">\u201cFermeture <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW212183142 BCX0\">d\u2019\u00e9tudes<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\"> et <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW212183142 BCX0\">archivage<\/span><\/span><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW212183142 BCX0\">\u201d) section of the <span class=\"TextRun SCXW162495763 BCX0\" lang=\"FR-CA\" xml:lang=\"FR-CA\" 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\"><span class=\"NormalTextRun CommentStart CommentHighlightPipeRestV2 CommentHighlightRest SCXW162495763 BCX0\">Toolbox<\/span><\/a><\/span> (<\/span><\/span><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun CommentStart SpellingErrorV2Themed CommentHighlightPipeRestV2 CommentHighlightRest SCXW212183142 BCX0\">Bo\u00eete<\/span><span class=\"NormalTextRun CommentHighlightRest SCXW212183142 BCX0\"> \u00e0 <\/span><span class=\"NormalTextRun SpellingErrorV2Themed CommentHighlightRest SCXW212183142 BCX0\">outils<\/span><\/span><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun CommentHighlightRest SCXW212183142 BCX0\">)<\/span><span class=\"NormalTextRun CommentHighlightPipeRestV2 SCXW212183142 BCX0\">, including a document called <\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">\u201c<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">FAQ: Frequently Asked Questions<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">\u201d<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\"> (\u201c<\/span><\/span><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW212183142 BCX0\">FAQ : <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW212183142 BCX0\">Foire<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\"> aux questions<\/span><\/span><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW212183142 BCX0\">\u201d), the Electronic Archiving Preparation Kit (\u201c<\/span><\/span><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW212183142 BCX0\">Trousse<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\"> de <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW212183142 BCX0\">pr\u00e9paration<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\"> \u00e0 <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW212183142 BCX0\">l\u2019archivage<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW212183142 BCX0\">\u00e9lectronique<\/span><\/span><span class=\"TextRun SCXW212183142 BCX0\" lang=\"EN-CA\" xml:lang=\"EN-CA\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW212183142 BCX0\">\u201d) and the current version of the Administrative Directive of the Centre de recherche du<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">\u202f<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">CHU de<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">\u202f<\/span><span class=\"NormalTextRun SCXW212183142 BCX0\">Qu\u00e9bec-Universit\u00e9 Laval: Archiving a clinical research project.<\/span><\/span><\/p>\n\n                                                                            <\/div>\n                                                    <\/div>\n                    <\/div>\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>Service responsible for archiving clinical research projects, following the &#8220;CHU de\u202fQu\u00e9bec-Universit\u00e9 Laval Research Centre Administrative Directive: Archiving of a Clinical Research Project&#8221; (&#8220;Directive administrative du Centre de recherche du CHU de Qu\u00e9bec-Universit\u00e9 Laval\u202f: Archivage d\u2019un projet de recherche clinique&#8221;).<\/p>\n","protected":false},"author":37,"featured_media":0,"parent":42183,"menu_order":8,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-65467","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>Research Projects Archiving - Centre de recherche du CHU de Qu\u00e9bec-Universit\u00e9 Laval<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.crchudequebec.ulaval.ca\/en\/platforms-and-services\/clinical-and-evaluative-research\/research-projects-archiving\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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