{"id":12242,"date":"2024-09-05T14:02:56","date_gmt":"2024-09-05T18:02:56","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?p=12242"},"modified":"2024-09-05T14:05:50","modified_gmt":"2024-09-05T18:05:50","slug":"new-investigational-drug-management-policy","status":"publish","type":"post","link":"https:\/\/www.rochester.edu\/ohsp\/new-investigational-drug-management-policy\/","title":{"rendered":"New! Investigational Drug Management Policy & Education Session"},"content":{"rendered":"

The Medication Management: Investigational Study Drug Policy<\/a><\/strong> is now in place, effective June 4, 2024. The policy was developed to define the responsibilities of the University\u2019s Investigational Drug Service (IDS)<\/a>, as it pertains to the management of prospective therapeutic interventional research that is conducted or supported by employees of the University. Among other IDS-specific procedures, the policy specifies that:<\/p>\n

    \n
  1. All human subject research involving drugs as the test object of a study will undergo ancillary review by IDS; and<\/li>\n
  2. Study teams are expected to delegate drug management responsibilities to IDS.<\/li>\n<\/ol>\n

    Study teams wishing to use methods other than IDS to manage investigational drugs will need to submit an exemption request<\/a> or review.<\/p>\n

    The policy and exemption request process will be reviewed during the September 12th<\/sup> UR-HRPP Educational Forum<\/a>\u00a0(with the recording available for later viewing via OHSP\u2019s UR-HRPP Educational Materials<\/a>).<\/p>\n

    Register for the 9\/12 UR-HRPP Educational Forum<\/a><\/p>\n

    For questions regarding UR-HRPP Educational Forums, contact Kelly Unsworth<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

    The Medication Management: Investigational Study Drug Policy is now in place, effective June 4, 2024. The policy was developed to define the responsibilities of the University\u2019s Investigational Drug Service (IDS),…<\/p>\n","protected":false},"author":52,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[106],"tags":[116,262],"class_list":["post-12242","post","type-post","status-publish","format-standard","hentry","category-updates","tag-educational-forum","tag-investigational-drug-service"],"acf":[],"yoast_head":"\nNew! Investigational Drug Management Policy & Education Session - Office for Human Subject Protection<\/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.rochester.edu\/ohsp\/new-investigational-drug-management-policy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New! Investigational Drug Management Policy & Education Session - Office for Human Subject Protection\" \/>\n<meta property=\"og:description\" content=\"The Medication Management: Investigational Study Drug Policy is now in place, effective June 4, 2024. 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