{"id":443,"date":"2023-04-24T17:12:56","date_gmt":"2023-04-24T15:12:56","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=443"},"modified":"2023-04-24T17:12:56","modified_gmt":"2023-04-24T15:12:56","slug":"cl07-clinical-performance-study-for-an-in-vitro-diagnostic-medical-device","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/clinical-trainings\/cl07-clinical-performance-study-for-an-in-vitro-diagnostic-medical-device\/","title":{"rendered":"CL07 – Clinical Performance Study for an In Vitro Diagnostic Medical Device"},"content":{"rendered":"\n
\n

REF. CL07 – INTRA \/ INTER<\/p>\n\n\n\n

CLINICAL<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
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COURSE DESCRIPTION<\/h2>\n\n\n\n

The demonstration of the product\u2019s compliance with the general requirements of Regulation (EU) 2017\/746 may include a clinical performance study, which is intended to produce data to clinically establish or confirm the analytical performance of a device. This course\u2019s objective is to identify the regulatory obligations relative to the implementation and conduct of a clinical performance study.<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
\n\t
\n\t\t

DURATION<\/h3>\n\t\t

1 day \/ 7 hours<\/p>\n\t<\/div>\n\t

\n\t\t\n\t\t

IN-PERSON<\/h3>\n\t<\/div>\n
\n\t\t\n\t\t

VIRTUAL CLASSROOM<\/h3>\n\t<\/div>\n<\/div>\n\n\n\n
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OBJECTIVES<\/h2>\n\n\n\n
    \n
  • Become familiar with the terms and vocabulary<\/li>\n\n\n\n
  • Understand the requirements of Regulation (EU) 2017\/746 and ISO 20916 regarding good practices for clinical performance studies<\/li>\n\n\n\n
  • Identify the essential documents required<\/li>\n\n\n\n
  • Become familiar with the basics to design and conduct a clinical performance study<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    TARGET TRAINEES<\/h2>\n\n\n\n
      \n
    • Manufacturers of In Vitro<\/em> Diagnostic Medical Devices (IVDMD)<\/li>\n\n\n\n
    • IVDMD development or market operators<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
      <\/div>\n\n\n\n
      \n

      PREREQUISITES<\/h2>\n\n\n\n

      No prior knowledge required<\/p>\n<\/div><\/div>\n\n\n\n

      <\/div>\n\n\n\n
      \n

      TRAINING RESOURCES<\/h2>\n\n\n\n
        \n
      • PowerPoint presentation handed out at the end of training<\/li>\n\n\n\n
      • Examples tailored to the company\u2019s products<\/li>\n\n\n\n
      • Reference to Regulation (EU) 2017\/746 (IVDR) and ISO 20916<\/li>\n\n\n\n
      • Distribution of the texts presented<\/li>\n\n\n\n
      • Quizzes<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
        <\/div>\n\n\n\n
        \n

        COURSE CONTENT<\/h2>\n\n\n\n

        Participants welcomed and presented\/Course objectives\/Presentation of the course content.<\/strong><\/p>\n\n\n\n

          \n
        1. Context and definitions\n
            \n
          • Terms and definitions<\/li>\n\n\n\n
          • Regulatory and legal requirements<\/li>\n\n\n\n
          • Ethical considerations<\/li>\n<\/ul>\n<\/li>\n\n\n\n
          • When should a clinical performance study be conducted?<\/li>\n\n\n\n
          • Study design\n
              \n
            • The different types of studies<\/li>\n\n\n\n
            • Design parameters<\/li>\n\n\n\n
            • The essential documents required<\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • Study conduct\n
                \n
              • Submission and regulatory evaluation of the study<\/li>\n\n\n\n
              • Conditions to be met to conduct the study<\/li>\n\n\n\n
              • Study conduct<\/li>\n\n\n\n
              • Monitoring quality<\/li>\n\n\n\n
              • Clinical performance study report<\/li>\n\n\n\n
              • Practical examples<\/li>\n<\/ul>\n<\/li>\n\n\n\n
              • Summary\/Q&A<\/li>\n\n\n\n
              • Course evaluation and conclusion<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n
                <\/div>\n\n\n\n
                \n

                EVALUATION METHODS<\/h2>\n\n\n\n
                  \n
                • Course evaluation quiz<\/li>\n\n\n\n
                • Satisfaction survey<\/li>\n\n\n\n
                • Attendance certificate<\/li>\n<\/ul>\n\n\n\n

                  This training is assessed based on an evaluation of each individual\u2019s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 80%).<\/em><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

                  REF. CL07 – INTRA \/ INTER CLINICAL COURSE DESCRIPTION The demonstration of the product\u2019s compliance with the general requirements of Regulation (EU) 2017\/746 may include a clinical performance study, which is intended to produce data to clinically establish or confirm the analytical performance of a device. This course\u2019s objective is to identify the regulatory obligations […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[12],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/443"}],"collection":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/comments?post=443"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/443\/revisions"}],"predecessor-version":[{"id":445,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/443\/revisions\/445"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=443"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=443"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=443"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}