{"id":429,"date":"2023-04-24T16:49:51","date_gmt":"2023-04-24T14:49:51","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=429"},"modified":"2023-04-24T16:49:51","modified_gmt":"2023-04-24T14:49:51","slug":"cl04-good-clinical-practices-according-to-iso-14155","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/clinical-trainings\/cl04-good-clinical-practices-according-to-iso-14155\/","title":{"rendered":"CL04 – Good Clinical Practices according to ISO 14155"},"content":{"rendered":"\n
\n

REF. CL04 – 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

Clinical development and post-market clinical follow-up of a Medical Device may include clinical investigations or studies to collect data on the product. These clinical investigations and post-market studies must be conducted in accordance with the Good Clinical Practices set out in ISO 14155, which ensures 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
  • Become familiar with the terms and vocabulary<\/li>\n\n\n\n
  • Become familiar with Good Clinical Practices according to ISO 14155<\/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\n\n\n
    • Interested parties (auditors, evaluators, etc.)<\/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
      • Work is based on applicable regulations and standards <\/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. Good Clinical Practices: context and definitions\n
            \n
          • Background and definitions<\/li>\n\n\n\n
          • Regulatory requirements (a review)<\/li>\n\n\n\n
          • Presentation of ISO 14155:2020<\/li>\n\n\n\n
          • Ethical considerations<\/li>\n\n\n\n
          • Roles and responsibilities<\/li>\n<\/ul>\n<\/li>\n\n\n\n
          • Good Clinical Practices: application\n
              \n
            • Essential study documents<\/li>\n\n\n\n
            • Major study stages<\/li>\n\n\n\n
            • Collection of study data<\/li>\n\n\n\n
            • Quality Assurance, Quality Control and Vigilance<\/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. CL04 – INTRA \/ INTER CLINICAL COURSE DESCRIPTION Clinical development and post-market clinical follow-up of a Medical Device may include clinical investigations or studies to collect data on the product. These clinical investigations and post-market studies must be conducted in accordance with the Good Clinical Practices set out in ISO 14155, which ensures ethical […]<\/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\/429"}],"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=429"}],"version-history":[{"count":2,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/429\/revisions"}],"predecessor-version":[{"id":433,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/429\/revisions\/433"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}