{"id":511,"date":"2022-04-08T13:49:18","date_gmt":"2022-04-08T11:49:18","guid":{"rendered":"http:\/\/raffeiner.atomproductions.at\/?post_type=leistung&#038;p=511"},"modified":"2022-04-08T13:49:20","modified_gmt":"2022-04-08T11:49:20","slug":"non-interventional-study-nis","status":"publish","type":"leistung","link":"https:\/\/www.studien-monitor.at\/en\/services\/non-interventional-study-nis\/","title":{"rendered":"Non-interventional study &#8211; NIS"},"content":{"rendered":"\n<p class=\"has-medium-font-size wp-block-paragraph\" style=\"letter-spacing:0px\">The term &#8216;observational study&#8217; (also &#8216;in-use study&#8217;) was mentioned for the very first time in the Austrian Medicinal Products Acts (Arzneimittelgesetz; AMG) in the year of 1994. Its primary purpose was to differentiate this type of study from a clinical trial. However, in view of the terminology commonly used in Europe, an amendment to the AMG replaced the term \u201cobservational study\u201d by the term \u201cnon-interventional study\u201d, abbreviated as \u201cNIS\u201d.<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><strong><mark style=\"background-color:#EFF3F5\" class=\"has-inline-color\">NIS is a systematic study of approved medicinal products on patients, provided that:<\/mark><\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>the medicinal product is used exclusively under the conditions mentioned in the marketing authorization;<\/li><li>the non-interventional study does not necessitate any additional diagnostic or therapeutic measures and hence does not additionally burden the patients;<\/li><li>the use of a particular therapeutic strategy is not stipulated in a trial protocol, it is in accordance with the medical doctrine, and the decision to prescribe the medicinal product is unequivocally separated from the decision to enroll a patient in the study.<\/li><\/ol>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><strong><mark style=\"background-color:#EFF3F5\" class=\"has-inline-color\">If the definition criteria are met, the following may be considered depending on the study design:<\/mark><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>PMOS: Post Marketing Observational Studies<\/li><li>Evaluation of registry data<\/li><li>PASS: Post authorization safety studies<\/li><li>Correlational studies with aggregated data<\/li><li>Case-control studies<\/li><\/ul>\n\n\n    <\/div>\n<\/div>\n<div class=\"box-grey-inset no-margin-bottom\">\n    <div class=\"container editor-content\">\n        <div class=\"row\">\n            <div class=\"col-12 col-lg-3\">\n                <div class=\"topline\"><\/div>\n                <h2 class=\"mb-2\">NIS service offerings<\/h2>\n            <\/div>\n            <div class=\"col-12 col-lg-9\">\n                <ul class=\"two-colums mt-0\">\n                    <li>Design and development of an observational and analysis plan;\r\n<\/li><li>Data management and documentation;\r\n<\/li><li>Submission to the Ethics Committee and notification\/reporting to the Austrian Federal Office for Safety in Health Care (Bundesamt f\u00fcr Sicherheit im Gesundheitswesen, BASG);\r\n<\/li><li>Compilation of adverse events and adverse event reporting;\r\n<\/li><li>Analysis and creation of a final report.\r\n<\/li><li>Trial site selection and site support;\r\n<\/li><li>Customized and affordable eCRF solutions;\r\n<\/li>                <\/ul>\n            <\/div>\n                            <div class=\"col-12 text-center\">\n                    <a href=\"https:\/\/www.studien-monitor.at\/en\/contact\/\" class=\"button\">Interested? Then go ahead and contact us&#8230;<\/a>\n                <\/div>\n                    <\/div>\n    <\/div>\n<\/div>\n<div class=\"limit-width box-white\">\n    <div class=\"editor-content alignfull wp-block-post-content is-layout-constrained has-global-padding\">\n","protected":false},"excerpt":{"rendered":"<p>The term &#8216;observational study&#8217; (also &#8216;in-use study&#8217;) was mentioned for the very first time in the Austrian Medicinal Products Acts (Arzneimittelgesetz; AMG) in the year of 1994. Its primary purpose was to differentiate this type of study from a clinical trial. However, in view of the terminology commonly used in Europe, an amendment to the [&hellip;]<\/p>\n","protected":false},"template":"","meta":{"_acf_changed":false,"inline_featured_image":false},"class_list":["post-511","leistung","type-leistung","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Non-interventional study - NIS - Raffeiner Studien Monitor<\/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.studien-monitor.at\/en\/services\/non-interventional-study-nis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Non-interventional study - NIS - Raffeiner Studien Monitor\" \/>\n<meta property=\"og:description\" content=\"The term &#8216;observational study&#8217; (also &#8216;in-use study&#8217;) was mentioned for the very first time in the Austrian Medicinal Products Acts (Arzneimittelgesetz; AMG) in the year of 1994. Its primary purpose was to differentiate this type of study from a clinical trial. However, in view of the terminology commonly used in Europe, an amendment to the [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.studien-monitor.at\/en\/services\/non-interventional-study-nis\/\" \/>\n<meta property=\"og:site_name\" content=\"Raffeiner Studien Monitor\" \/>\n<meta property=\"article:modified_time\" content=\"2022-04-08T11:49:20+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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/services\\\/non-interventional-study-nis\\\/\",\"url\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/services\\\/non-interventional-study-nis\\\/\",\"name\":\"Non-interventional study - NIS - Raffeiner Studien Monitor\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/#website\"},\"datePublished\":\"2022-04-08T11:49:18+00:00\",\"dateModified\":\"2022-04-08T11:49:20+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/services\\\/non-interventional-study-nis\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/services\\\/non-interventional-study-nis\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/services\\\/non-interventional-study-nis\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Non-interventional study &#8211; NIS\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/\",\"name\":\"Raffeiner Studien Monitor\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.studien-monitor.at\\\/en\\\/?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":"Non-interventional study - NIS - Raffeiner Studien Monitor","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.studien-monitor.at\/en\/services\/non-interventional-study-nis\/","og_locale":"en_US","og_type":"article","og_title":"Non-interventional study - NIS - Raffeiner Studien Monitor","og_description":"The term &#8216;observational study&#8217; (also &#8216;in-use study&#8217;) was mentioned for the very first time in the Austrian Medicinal Products Acts (Arzneimittelgesetz; AMG) in the year of 1994. 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