{"id":441,"date":"2023-04-24T17:05:49","date_gmt":"2023-04-24T15:05:49","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=441"},"modified":"2023-04-24T17:05:49","modified_gmt":"2023-04-24T15:05:49","slug":"cl06-clinical-investigations-and-good-clinical-practices-according-to-iso-14155","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/clinical-trainings\/cl06-clinical-investigations-and-good-clinical-practices-according-to-iso-14155\/","title":{"rendered":"CL06 – Clinical Investigations and Good Clinical Practices according to ISO 14155"},"content":{"rendered":"\n
\n

REF. CL06 – INTRA \/ INTER<\/p>\n\n\n\n

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

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

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

The demonstration of a Medical Device\u2019s compliance with the General Safety and Performance Requirements may include a clinical investigation. The goal of this clinical investigation is to collect safety and performance data specific to the device. A clinical investigation must be conducted in accordance with Good Clinical Practices, which ensure ethical and scientific quality.<\/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
\n

OBJECTIVES<\/h2>\n\n\n\n
    \n
  • Identify the regulatory stages and obligations for an investigation<\/li>\n\n\n\n
  • Understand the requirements for a clinical investigation in order to comply with Regulation (EU) 2017\/745, the legal obligations in effect, and Good Clinical Practices according to ISO 14155:2020<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    TARGET TRAINEES<\/h2>\n\n\n\n
      \n
    • Medical Device manufacturers<\/li>\n\n\n\n
    • Medical Device 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
      • Case studies<\/li>\n\n\n\n
      • Work is based on applicable regulations and standards <\/li>\n\n\n\n
      • Distribution of the information 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. Clinical investigation: context and definitions\n
            \n
          • Terms and definitions<\/li>\n\n\n\n
          • Regulatory (Regulation (EU) 2017\/745) and legal framework<\/li>\n\n\n\n
          • The different types of studies<\/li>\n\n\n\n
          • The different parties and their responsibilities<\/li>\n\n\n\n
          • Investigation design<\/li>\n<\/ul>\n<\/li>\n\n\n\n
          • Clinical investigation: essential documents\n
              \n
            • Study documents<\/li>\n\n\n\n
            • Submission and evaluation of the investigation<\/li>\n\n\n\n
            • Major study stages<\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • GCP: context and application\n
                \n
              • ISO 14155<\/li>\n\n\n\n
              • Ethical considerations<\/li>\n\n\n\n
              • Quality Assurance and Control<\/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. CL06 – INTRA \/ INTER CLINICAL COURSE DESCRIPTION The demonstration of a Medical Device\u2019s compliance with the General Safety and Performance Requirements may include a clinical investigation. The goal of this clinical investigation is to collect safety and performance data specific to the device. A clinical investigation must be conducted in accordance with Good […]<\/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\/441"}],"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=441"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/441\/revisions"}],"predecessor-version":[{"id":442,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/441\/revisions\/442"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=441"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=441"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=441"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}