{"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":"2026-09-09T17:23:17","modified_gmt":"2026-09-09T21:23:17","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":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-3706","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Data and Safety Monitoring Plans","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"","title":"<h2>Developing an appropriate DSMP<\/h2>","description":"Principal Investigators (PI) are responsible for the development of DSMPs. Based on the nature, size, and complexity of the research, DSMPs can range from a simple plan, where the PI periodically reviews safety data, to a more extensive plan that involves a Data &amp; Safety Monitoring Committee (DSMC).\r\n\r\nAt a minimum, DSMPs should identify the:\r\n<ul>\r\n \t<li>Individual(s) responsible for monitoring;<\/li>\r\n \t<li>Process for conducting the monitoring;<\/li>\r\n \t<li>Mechanism for documenting the monitoring; and<\/li>\r\n \t<li>Who will be notified of the outcome of the monitoring activity (e.g., Institutional Review Board [IRB], study sites, sponsor).<\/li>\r\n<\/ul>","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"title","sub_heading":"Things to consider when developing a DSMP"},{"acf_fc_layout":"accordion","accordion_title":"Have you complied with all of the applicable policies\/requirements? ","icon":"","row_content":"As applicable, DSMPs must meet:\r\n<ul>\r\n \t<li>institutional requirements,<\/li>\r\n \t<li>regulatory requirements (e.g., Food &amp; Drug Administration), and<\/li>\r\n \t<li>sponsor\/funding agency requirements (e.g., National Institutes of Health).<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Are you confusing DSMPs with general safety monitoring?","icon":"","row_content":"Regardless of risk-level, all study teams must monitor for research events that could impact subject safety. Reviewing IRB policy defines the types of research events that must be reported to the Reviewing IRB. E.g., the <a href=\"http:\/\/www.rochester.edu\/ohsp\/documents\/ohsp\/pdf\/policiesAndGuidance\/Policy_801_Reporting_Research_Events.pdf\">IRB requires the reporting of all events deemed unanticipated, related and serious events<\/a>. Adherence with these policies is required regardless of what a DSMP details.\r\n\r\nFor greater than minimal risk research, DSMPs may include this type of monitoring and reporting, but it is not, in and of itself, a DSMP.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Have you critically assessed the appropriateness of the DSMP based upon the study procedures and their associated risks?","icon":"","row_content":"The level of monitoring must be commensurate with the nature of the study. DSMPs that are insufficient may inadvertently increase risks to subjects while DSMPs that are too extensive may run ineffectively, thereby increasing risks to subjects, or set study teams up for a compliance problem by not following the plan. Examples of appropriate monitoring levels based on risk are provided in Appendix 1 of <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_506_Data_Safety_Monitoring.pdf\">OHSP Policy 506: Data &amp; Safety Monitoring<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If a DSMC will be formed, what will be their responsibilities?","icon":"","row_content":"The responsibilities of a DSMC (or any other type of monitoring committee) will depend on the nature of the study. Generally, responsibilities should include interim monitoring for efficacy, safety, study conduct (e.g., recruitment &amp; retention, non-compliance, completeness of the data) and continued relevance of the study question.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Who will act as a Safety Monitor or serve on the DSMC?","icon":"","row_content":"Generally, safety monitors and committee members should be free of any conflicts of interest (with the study and study sponsors) and have relevant expertise based on the role they serve within the DSMP.","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>Complying with a DSMP<\/h2>","content":"Once a study is approved, the <strong>PI is responsible for ensuring adherence to the DSMP plan<\/strong>, as described in the study protocol and IRB application. As with all study procedures, documentation must be maintained to demonstrate the execution of the DSMP. Best documentation practices include maintaining:\r\n<ul>\r\n \t<li>A written summary of each meeting or data review, noting the date\/time and venue of communication (e.g., in-person, teleconference, etc.), participant list and any recommendations resulting from the meeting. A template for doing so is available via <a href=\"https:\/\/www.rochester.edu\/ohsp\/templates\/#studydocumentation\">OHSP's Templates<\/a>. Additional templates\/examples are readily available via internet searches, as well.<\/li>\r\n \t<li>Documentation of communications to study sites, IRBs, sponsors and regulatory agencies.<\/li>\r\n \t<li>Documentation of DSMC member and\/or Safety Monitor training\/experience (e.g., curriculum vitae) and conflict of interest disclosure.<\/li>\r\n<\/ul>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Related resources<\/h2>","description":"<h4 style=\"text-align: center;\">training<\/h4>","background_color":"#f4f4f4","width":"width-medium","columns":"1","cards":[{"card_title":"<h5>UR-HRPP Educational Forums<\/h5>","card_text":"The archived <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/educational-forum\/\">UR-HRPP Educational Forums<\/a> identified below are available in Blackboard. To access recordings, follow our <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/self-enrollment-instructions\/\">Blackboard Self-Enrollment Instructions<\/a> and enroll in the course titled \u2018UR-HRPP Educational Materials\u2019.\r\n<ul>\r\n \t<li>3\/12\/2020 \u2013 Adverse Events through the Lens of the IRB<\/li>\r\n \t<li>12\/16\/2014 \u2013 Planning for Your Plan: Data and Safety Monitoring Plan Development &amp; Implementation<\/li>\r\n<\/ul>","card_background_color":"#FFFFFF","card_hover_color":"transparent","card_link":"","card_hover_arrow":"","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Clinical &amp; Translational Science Institute (CTSI) Webinars<\/h5>","card_text":"Recordings of the following CTSI webinars are also available in Blackboard. Enrollment is not required, but users will need to log into Blackboard to access the\r\nrecordings.\r\n<ul>\r\n \t<li><a href=\"https:\/\/rochester.hosted.panopto.com\/Panopto\/Pages\/Viewer.aspx?id=efc7b74f-e54b-4388-9537-b0f40130378e\">1\/11\/2024 \u2013 Data and Safety Monitoring Boards for Clinical Trials: Safety Monitoring Plans<\/a><\/li>\r\n \t<li><a href=\"https:\/\/rochester.hosted.panopto.com\/Panopto\/Pages\/Viewer.aspx?id=ee214b27-2888-4e97-9ebb-b1080139b50a\">1\/26\/2024 \u2013 Data and Safety Monitoring Boards for Clinical Trials: Approaches Used<\/a><\/li>\r\n<\/ul>","card_background_color":"#FFFFFF","card_hover_color":"transparent","card_link":"","card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"pt-0 max-text-center","title":"","description":"<h4 style=\"text-align: center;\">external resources<\/h4>","background_color":"#f4f4f4","width":"width-large","columns":"3","cards":[{"card_title":"<h5>FDA guidance: Establishment and operation of clinical trial data monitoring committees<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/establishment-and-operation-clinical-trial-data-monitoring-committees","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>National Institute of Mental Health: Data and safety monitoring plan writing guidance<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.nimh.nih.gov\/funding\/clinical-research\/data-and-safety-monitoring-plan-writing-guidance","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5><\/h5>","card_text":"<h5>Clinical &amp; Translational Science Award (CTSA) Collaborative DSMB Workgroup: DSMB training manual<\/h5>","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/dl.tufts.edu\/concern\/pdfs\/tm70n6743","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Data and Safety Monitoring Plans - Office for Human Subject Protection - 糖心传媒<\/title>\n<meta name=\"description\" content=\"Definition of Data and Safety Monitoring Plan (DSMP), and steps to develop and comply with DSMPs. 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