{"id":2185,"date":"2022-04-12T14:30:01","date_gmt":"2022-04-12T14:30:01","guid":{"rendered":"https:\/\/blogs.napier.ac.uk\/rie\/?p=2185"},"modified":"2022-04-12T12:40:41","modified_gmt":"2022-04-12T12:40:41","slug":"updated-research-policies-data-management-and-adverse-events-reporting","status":"publish","type":"post","link":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/","title":{"rendered":"Updated Research Policies: Data Management and Adverse Events reporting"},"content":{"rendered":"<p>The University has recently updated its policies on data management and adverse events in research. This post summarises the polices and the changes for each.<\/p>\n<h2>Data Management Policy<\/h2>\n<p>The data management policy was updated and approved by the Research and Innovation Committee in March 2022. This was updated to meet funder and sector changes since the implementation of our RDM policy in 2015. The new policy is more aligned with the current general practice around data management but specifically around making research data open and FAIR.<\/p>\n<p><a href=\"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1041 aligncenter\" src=\"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram-300x295.jpg\" alt=\"\" width=\"300\" height=\"295\" srcset=\"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram-300x295.jpg 300w, https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram.jpg 600w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<p>The policy\u00a0applies to all researchers and support staff employed to conduct research and innovation activities under the auspices of the University and to all research data regardless of how it is funded (external\/ internal \/unfunded). It includes research undertaken by research postgraduate students. Responsibilities are defined for researchers, PIs, Deans and the University (Professional Support Services).<\/p>\n<p>Policy document: <a href=\"https:\/\/staff.napier.ac.uk\/services\/research-innovation-office\/policies\/Documents\/Research%20Data%20Management%20Policy%202022.pdf\">https:\/\/staff.napier.ac.uk\/services\/research-innovation-office\/policies\/Documents\/Research%20Data%20Management%20Policy%202022.pdf\u00a0<\/a><\/p>\n<p>More information and guidance on data management can be found on our webpages: <a href=\"https:\/\/staff.napier.ac.uk\/services\/research-innovation-office\/research-data\/Pages\/introduction.aspx\">https:\/\/staff.napier.ac.uk\/services\/research-innovation-office\/research-data\/Pages\/introduction.aspx\u00a0<\/a><\/p>\n<p>Training sessions are advertised though the Researcher Development Programme: <a href=\"https:\/\/staff.napier.ac.uk\/services\/research-innovation-office\/training\/Pages\/Upcoming-Researcher-Development-Events.aspx\">https:\/\/staff.napier.ac.uk\/services\/research-innovation-office\/training\/Pages\/Upcoming-Researcher-Development-Events.aspx<\/a><\/p>\n<h2>Adverse Events in Research<\/h2>\n<p>The policy for reporting any adverse events in research activities has been updated to include a clearer remit and update the process of reporting incidents. This was approved by the University Research Integrity Committee in January 2022. The policy describes the procedure for identifying, recording and reporting adverse events (AEs) and urgent safety measures (USMs) occurring in research projects that are sponsored by ENU. This includes clinical trials (non-CTIMPS) and some non-clinical psychology and sports projects which may result in distress to participants or adverse events.<\/p>\n<p>The Chief\/Principal Investigator will be responsible for identifying and reporting AEs and other safety events to the University Sponsor in RIE within 24 hours of becoming aware of the event. The University has an adverse event proforma which should be completed and emailed to <a href=\"mailto:researchintegrity@napier.ac.uk\">researchintegrity@napier.ac.uk<\/a>. This will be assessed and if found to be an AE as a result of the research, RIE will be responsible for reporting to the NHS REC for ENU-sponsored non-CTIMP studies, or for non-clinical studies the report will go to the relevant University integrity committee.<\/p>\n<p>Policy document: <a href=\"https:\/\/staff.napier.ac.uk\/services\/research-innovation-office\/policies\/Documents\/SOP%20Identifying%20recording%20and%20reporting%20AEs%20in%20research_Dec21.pdf\">https:\/\/staff.napier.ac.uk\/services\/research-innovation-office\/policies\/Documents\/SOP%20Identifying%20recording%20and%20reporting%20AEs%20in%20research_Dec21.pdf\u00a0<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The University has recently updated its policies on data management and adverse events in research. This post summarises the polices and the changes for each. Data Management Policy The data management policy was updated and approved by the Research and&hellip; <br \/><a class=\"read-more-button\" href=\"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/\">Read more<\/a><\/p>\n","protected":false},"author":136,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_crdt_document":"","jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[17,104],"tags":[25,73,32,72],"class_list":["post-2185","post","type-post","status-publish","format-standard","hentry","category-ethics","category-research-data","tag-ethics","tag-integrity","tag-open-access","tag-research-data"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Updated Research Policies: Data Management and Adverse Events reporting - Research Innovation Enterprise<\/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:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Updated Research Policies: Data Management and Adverse Events reporting - Research Innovation Enterprise\" \/>\n<meta property=\"og:description\" content=\"The University has recently updated its policies on data management and adverse events in research. This post summarises the polices and the changes for each. Data Management Policy The data management policy was updated and approved by the Research and&hellip; Read more\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/\" \/>\n<meta property=\"og:site_name\" content=\"Research Innovation Enterprise\" \/>\n<meta property=\"article:published_time\" content=\"2022-04-12T14:30:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram-300x295.jpg\" \/>\n<meta name=\"author\" content=\"lindsayramage\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@EdNapierRIO\" \/>\n<meta name=\"twitter:site\" content=\"@EdNapierRIO\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"lindsayramage\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/\"},\"author\":{\"name\":\"lindsayramage\",\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/#\\\/schema\\\/person\\\/8c19596a943f6eb33736e0be7bd2e31c\"},\"headline\":\"Updated Research Policies: Data Management and Adverse Events reporting\",\"datePublished\":\"2022-04-12T14:30:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/\"},\"wordCount\":413,\"image\":{\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/wp-content\\\/uploads\\\/sites\\\/39\\\/2019\\\/01\\\/research_data_life_diagram-300x295.jpg\",\"keywords\":[\"ethics\",\"integrity\",\"open access\",\"Research data\"],\"articleSection\":[\"Ethics\",\"Research Data\"],\"inLanguage\":\"en-GB\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/\",\"url\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/\",\"name\":\"Updated Research Policies: Data Management and Adverse Events reporting - Research Innovation Enterprise\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/wp-content\\\/uploads\\\/sites\\\/39\\\/2019\\\/01\\\/research_data_life_diagram-300x295.jpg\",\"datePublished\":\"2022-04-12T14:30:01+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/#\\\/schema\\\/person\\\/8c19596a943f6eb33736e0be7bd2e31c\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/#breadcrumb\"},\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/#primaryimage\",\"url\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/wp-content\\\/uploads\\\/sites\\\/39\\\/2019\\\/01\\\/research_data_life_diagram.jpg\",\"contentUrl\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/wp-content\\\/uploads\\\/sites\\\/39\\\/2019\\\/01\\\/research_data_life_diagram.jpg\",\"width\":600,\"height\":590},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/updated-research-policies-data-management-and-adverse-events-reporting\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Updated Research Policies: Data Management and Adverse Events reporting\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/#website\",\"url\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/\",\"name\":\"Research Innovation Enterprise\",\"description\":\"News, funding opportunities, and support from Research, Innovation &amp; Enterprise\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-GB\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/#\\\/schema\\\/person\\\/8c19596a943f6eb33736e0be7bd2e31c\",\"name\":\"lindsayramage\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d85291baa6f250d9be2c82af2485601d886ff3e3dbcf05f769fe2b1a9c79f6f9?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d85291baa6f250d9be2c82af2485601d886ff3e3dbcf05f769fe2b1a9c79f6f9?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d85291baa6f250d9be2c82af2485601d886ff3e3dbcf05f769fe2b1a9c79f6f9?s=96&d=mm&r=g\",\"caption\":\"lindsayramage\"},\"url\":\"https:\\\/\\\/blogs.napier.ac.uk\\\/rie\\\/author\\\/lindsayramage\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Updated Research Policies: Data Management and Adverse Events reporting - Research Innovation Enterprise","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/","og_locale":"en_GB","og_type":"article","og_title":"Updated Research Policies: Data Management and Adverse Events reporting - Research Innovation Enterprise","og_description":"The University has recently updated its policies on data management and adverse events in research. This post summarises the polices and the changes for each. Data Management Policy The data management policy was updated and approved by the Research and&hellip; Read more","og_url":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/","og_site_name":"Research Innovation Enterprise","article_published_time":"2022-04-12T14:30:01+00:00","og_image":[{"url":"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram-300x295.jpg","type":"","width":"","height":""}],"author":"lindsayramage","twitter_card":"summary_large_image","twitter_creator":"@EdNapierRIO","twitter_site":"@EdNapierRIO","twitter_misc":{"Written by":"lindsayramage","Estimated reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/#article","isPartOf":{"@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/"},"author":{"name":"lindsayramage","@id":"https:\/\/blogs.napier.ac.uk\/rie\/#\/schema\/person\/8c19596a943f6eb33736e0be7bd2e31c"},"headline":"Updated Research Policies: Data Management and Adverse Events reporting","datePublished":"2022-04-12T14:30:01+00:00","mainEntityOfPage":{"@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/"},"wordCount":413,"image":{"@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/#primaryimage"},"thumbnailUrl":"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram-300x295.jpg","keywords":["ethics","integrity","open access","Research data"],"articleSection":["Ethics","Research Data"],"inLanguage":"en-GB"},{"@type":"WebPage","@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/","url":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/","name":"Updated Research Policies: Data Management and Adverse Events reporting - Research Innovation Enterprise","isPartOf":{"@id":"https:\/\/blogs.napier.ac.uk\/rie\/#website"},"primaryImageOfPage":{"@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/#primaryimage"},"image":{"@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/#primaryimage"},"thumbnailUrl":"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram-300x295.jpg","datePublished":"2022-04-12T14:30:01+00:00","author":{"@id":"https:\/\/blogs.napier.ac.uk\/rie\/#\/schema\/person\/8c19596a943f6eb33736e0be7bd2e31c"},"breadcrumb":{"@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/#breadcrumb"},"inLanguage":"en-GB","potentialAction":[{"@type":"ReadAction","target":["https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/"]}]},{"@type":"ImageObject","inLanguage":"en-GB","@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/#primaryimage","url":"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram.jpg","contentUrl":"https:\/\/blogs.napier.ac.uk\/rie\/wp-content\/uploads\/sites\/39\/2019\/01\/research_data_life_diagram.jpg","width":600,"height":590},{"@type":"BreadcrumbList","@id":"https:\/\/blogs.napier.ac.uk\/rie\/updated-research-policies-data-management-and-adverse-events-reporting\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/blogs.napier.ac.uk\/rie\/"},{"@type":"ListItem","position":2,"name":"Updated Research Policies: Data Management and Adverse Events reporting"}]},{"@type":"WebSite","@id":"https:\/\/blogs.napier.ac.uk\/rie\/#website","url":"https:\/\/blogs.napier.ac.uk\/rie\/","name":"Research Innovation Enterprise","description":"News, funding opportunities, and support from Research, Innovation &amp; Enterprise","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/blogs.napier.ac.uk\/rie\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-GB"},{"@type":"Person","@id":"https:\/\/blogs.napier.ac.uk\/rie\/#\/schema\/person\/8c19596a943f6eb33736e0be7bd2e31c","name":"lindsayramage","image":{"@type":"ImageObject","inLanguage":"en-GB","@id":"https:\/\/secure.gravatar.com\/avatar\/d85291baa6f250d9be2c82af2485601d886ff3e3dbcf05f769fe2b1a9c79f6f9?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/d85291baa6f250d9be2c82af2485601d886ff3e3dbcf05f769fe2b1a9c79f6f9?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/d85291baa6f250d9be2c82af2485601d886ff3e3dbcf05f769fe2b1a9c79f6f9?s=96&d=mm&r=g","caption":"lindsayramage"},"url":"https:\/\/blogs.napier.ac.uk\/rie\/author\/lindsayramage\/"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p8bk4z-zf","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/posts\/2185","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/users\/136"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/comments?post=2185"}],"version-history":[{"count":3,"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/posts\/2185\/revisions"}],"predecessor-version":[{"id":2189,"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/posts\/2185\/revisions\/2189"}],"wp:attachment":[{"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/media?parent=2185"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/categories?post=2185"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.napier.ac.uk\/rie\/wp-json\/wp\/v2\/tags?post=2185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}