{"id":25859,"date":"2022-10-24T03:29:18","date_gmt":"2022-10-24T08:29:18","guid":{"rendered":"https:\/\/en.ennov.com\/?p=25859"},"modified":"2022-10-24T03:29:18","modified_gmt":"2022-10-24T08:29:18","slug":"aggregate-reports","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/glossary\/aggregate-reports\/","title":{"rendered":"Aggregate reports"},"content":{"rendered":"\n<p>Reports of a set of cases, meant for regulatory authorities.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Annual Safety Report (ASR):<\/strong>\u00a0In clinical trials, an annual report of all newly available safety information. An ASR includes a global analysis for all trials with the same Investigational Medicinal Product (IMP).<\/li><li><strong>Development Safety Update Report (DSUR):<\/strong>\u00a0Annual review and evaluation by the sponsor for regulators of all pertinent safety information collected during the reporting period related to a drug, biologic or vaccine under development, whether or not it is marketed.<\/li><li><strong>Periodic Safety Update Report (PSUR):<\/strong>\u00a0Also called PBRER (Periodic Benefit Risk Evaluation Report). This report (internationally agreed format) provides a periodic comprehensive assessment of the worldwide safety, efficacy and effectiveness data of a marketed drug or biological product. It contains a summary of relevant data, a scientific evaluation, and data concerning sales volume, prescription and population exposure.<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Reports of a set of cases, meant for regulatory authorities. Annual Safety Report (ASR):\u00a0In clinical trials, an annual report of all newly available safety information. An ASR includes a global analysis for all trials with the same Investigational Medicinal Product (IMP). Development Safety Update Report (DSUR):\u00a0Annual review and evaluation by the sponsor for regulators of [&hellip;]<\/p>\n","protected":false},"author":232,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[180],"tags":[],"type_content":[179],"job":[],"employees_type":[],"class_list":["post-25859","post","type-post","status-publish","format-standard","hentry","category-glossary","type_content-glossaire","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.2.1 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Aggregate reports<\/title>\n<meta name=\"description\" content=\"Reports of a set of cases, meant for regulatory authorities. 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