{"id":3706,"date":"2024-01-04T16:14:50","date_gmt":"2024-01-04T21:14:50","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=3706"},"modified":"2025-03-11T18:06:28","modified_gmt":"2025-03-11T22:06:28","slug":"data-safety-monitoring-plans","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/","title":{"rendered":"Data and Safety Monitoring Plans"},"content":{"rendered":"<p>Data and Safety Monitoring Plans (DSMPs) describe the oversight and monitoring of study conduct. The goal of this plan is to ensure:<\/p>\n<ul>\n<li>That important information that may affect the safety or welfare of subjects is collected, reviewed and acted upon as quickly as possible;<\/li>\n<li>The validity and integrity of the research data; and<\/li>\n<li>The continued scientific merit of the research.<\/li>\n<\/ul>\n<p>Per <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_506_Data_Safety_Monitoring.pdf\">Office for Human Subject Protection (OHSP) Policy 506: Data &amp; Safety Monitoring<\/a>, formal (written) DSMPs:<\/p>\n<ul>\n<li>Are required for all research posing greater than minimal risk<\/li>\n<li>May be required for studies involving minimal risk, depending on the nature of the study.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Data and Safety Monitoring Plans (DSMPs) describe the oversight and monitoring of study conduct. The goal of this plan is to ensure: That important information that may affect the safety&hellip;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":236,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3706","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Data and Safety Monitoring Plans - Office for Human Subject Protection - University of Rochester<\/title>\n<meta name=\"description\" content=\"Definition of Data and Safety Monitoring Plan (DSMP), and steps to develop and comply with DSMPs. Guidance issued by OHSP.\" \/>\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.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Data and Safety Monitoring Plans - Office for Human Subject Protection - University of Rochester\" \/>\n<meta property=\"og:description\" content=\"Definition of Data and Safety Monitoring Plan (DSMP), and steps to develop and comply with DSMPs. Guidance issued by OHSP.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/\" \/>\n<meta property=\"og:site_name\" content=\"Office for Human Subject Protection\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-11T22:06:28+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/data-safety-monitoring-plans\\\/\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/data-safety-monitoring-plans\\\/\",\"name\":\"Data and Safety Monitoring Plans - Office for Human Subject Protection - University of Rochester\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#website\"},\"datePublished\":\"2024-01-04T21:14:50+00:00\",\"dateModified\":\"2025-03-11T22:06:28+00:00\",\"description\":\"Definition of Data and Safety Monitoring Plan (DSMP), and steps to develop and comply with DSMPs. Guidance issued by OHSP.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/data-safety-monitoring-plans\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/data-safety-monitoring-plans\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/data-safety-monitoring-plans\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Resources\",\"item\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Data and Safety Monitoring Plans\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#website\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/\",\"name\":\"Office for Human Subject Protection\",\"description\":\"University of Rochester\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Data and Safety Monitoring Plans - Office for Human Subject Protection - University of Rochester","description":"Definition of Data and Safety Monitoring Plan (DSMP), and steps to develop and comply with DSMPs. Guidance issued by OHSP.","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:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/","og_locale":"en_US","og_type":"article","og_title":"Data and Safety Monitoring Plans - Office for Human Subject Protection - University of Rochester","og_description":"Definition of Data and Safety Monitoring Plan (DSMP), and steps to develop and comply with DSMPs. Guidance issued by OHSP.","og_url":"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/","og_site_name":"Office for Human Subject Protection","article_modified_time":"2025-03-11T22:06:28+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/","name":"Data and Safety Monitoring Plans - Office for Human Subject Protection - University of Rochester","isPartOf":{"@id":"https:\/\/www.rochester.edu\/ohsp\/#website"},"datePublished":"2024-01-04T21:14:50+00:00","dateModified":"2025-03-11T22:06:28+00:00","description":"Definition of Data and Safety Monitoring Plan (DSMP), and steps to develop and comply with DSMPs. Guidance issued by OHSP.","breadcrumb":{"@id":"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.rochester.edu\/ohsp\/"},{"@type":"ListItem","position":2,"name":"Resources","item":"https:\/\/www.rochester.edu\/ohsp\/resources\/"},{"@type":"ListItem","position":3,"name":"Data and Safety Monitoring Plans"}]},{"@type":"WebSite","@id":"https:\/\/www.rochester.edu\/ohsp\/#website","url":"https:\/\/www.rochester.edu\/ohsp\/","name":"Office for Human Subject Protection","description":"University of Rochester","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rochester.edu\/ohsp\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/3706","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/users\/36"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/comments?post=3706"}],"version-history":[{"count":12,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/3706\/revisions"}],"predecessor-version":[{"id":14652,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/3706\/revisions\/14652"}],"up":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/236"}],"wp:attachment":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/media?parent=3706"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}