{"id":127,"date":"2018-09-07T14:57:38","date_gmt":"2018-09-07T14:57:38","guid":{"rendered":"http:\/\/www.montclair.edu\/institutional-review-board\/?page_id=127"},"modified":"2019-11-21T12:24:41","modified_gmt":"2019-11-21T17:24:41","slug":"clinical-trials-data-safety-monitoring-plans","status":"publish","type":"page","link":"https:\/\/www.montclair.edu\/institutional-review-board\/faqs\/clinical-trials-data-safety-monitoring-plans\/","title":{"rendered":"Clinical Trials: Data Safety Monitoring Plans"},"content":{"rendered":"<p>To assist investigators in complying with the NIH data safety monitoring policy, please visit\u00a0<a rel=\"noopener\" href=\"http:\/\/grants.nih.gov\/grants\/policy\/hs\/data_safety.htm\" target=\"_blank\">guidance and sample DSMP templates<\/a>\u00a0on the NIH website.<\/p>\n<p>See also:<\/p>\n<ul>\n<li><a rel=\"noopener\" href=\"http:\/\/www.ninds.nih.gov\/research\/clinical_research\/basics\/glossary.htm\" target=\"_blank\">NINDS Glossary of Clinical Research Terms<\/a><\/li>\n<li><a rel=\"noopener\" href=\"http:\/\/grants.nih.gov\/grants\/guide\/notice-files\/not98-084.html\" target=\"_blank\">NIH Policy for Data and Safety Monitoring<\/a><\/li>\n<li><a rel=\"noopener\" href=\"http:\/\/www.grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-00-038.html\" target=\"_blank\">Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/www.fda.gov\/downloads\/regulatoryinformation\/guidances\/ucm127073.pdf\" target=\"_blank\">FDA Guidance for Clinical Trial Sponsors<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM269919.pdf\" target=\"_blank\">FDA: Oversight of Clinical Investigations<\/a><\/li>\n<\/ul>\n<p>National Institute of Diabetes and Digestive and Kidney Diseases (NDDK):<\/p>\n<ul>\n<li><a rel=\"noopener\" href=\"https:\/\/www.niddk.nih.gov\/research-funding\/human-subjects-research\/policies-clinical-researchers\/data-safety-monitoring-plans\" target=\"_blank\">Generic DSMP for studies requiring a DSMB<\/a><\/li>\n<\/ul>\n<p dir=\"ltr\">DSMP Guidelines from various NIH \u00a0Institutes:<\/p>\n<ul>\n<li><a rel=\"noopener\" href=\"https:\/\/deainfo.nci.nih.gov\/grantspolicies\/datasafety.pdf\" target=\"_blank\">National Cancer Institute (NCI)<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/www.nei.nih.gov\/grants-and-training\/policies-and-procedures\/guidelines-data-and-safety-monitoring-clinical-trials\" target=\"_blank\">National Eye Institute (NEI)<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/nccih.nih.gov\/research\/policies\/datasafety\" target=\"_blank\">National Center for Complementary and Integrative Health (NCCIH)<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/www.nichd.nih.gov\/grants-contracts\/process-strategies\/policies\/data-safety\" target=\"_blank\">National Institute of Child Health &amp; Human Development (NICHD)<\/a><\/li>\n<li><a rel=\"noopener\" href=\"http:\/\/www.nhlbi.nih.gov\/funding\/policies\/dsmpolicy.htm\" target=\"_blank\">National Heart, Lung and Blood Institute (NHLBI)<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/www.niaid.nih.gov\/research\/data-and-safety-monitoring-boards\" target=\"_blank\">National Institute of Allergy and Infectious Diseases (NIAID)<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/www.nimh.nih.gov\/funding\/clinical-research\/data-and-safety-monitoring-plan-writing-guidance.shtml\" target=\"_blank\">National Institute of Mental Health (NIMH)<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/www.niams.nih.gov\/grants-funding\/data-safety-monitoring\/dsm-guidelines\" target=\"_blank\">National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)<\/a><\/li>\n<li><a rel=\"noopener\" href=\"https:\/\/www.ninds.nih.gov\/Funding\/Apply-Funding\/Application-Support-Library\/NINDS-Guidelines-Data-and-Safety-Monitoring\" target=\"_blank\">National Institute of Neurological Disorders and Stroke (NINDS)<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>To assist investigators in complying with the NIH data safety monitoring policy, please visit\u00a0guidance and sample DSMP templates\u00a0on the NIH website. See also: NINDS Glossary of Clinical Research Terms NIH Policy for Data and Safety Monitoring Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials FDA Guidance for Clinical [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":539,"parent":97,"menu_order":16,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-127","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages\/127","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/comments?post=127"}],"version-history":[{"count":3,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages\/127\/revisions"}],"predecessor-version":[{"id":985,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages\/127\/revisions\/985"}],"up":[{"embeddable":true,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages\/97"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/media\/539"}],"wp:attachment":[{"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/media?parent=127"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}