{"id":4057,"date":"2024-03-12T07:41:51","date_gmt":"2024-03-12T07:41:51","guid":{"rendered":"https:\/\/mycetoma.edu.sd\/?page_id=4057"},"modified":"2024-03-12T07:41:51","modified_gmt":"2024-03-12T07:41:51","slug":"clinical-trials-workshop","status":"publish","type":"page","link":"https:\/\/mycetoma.edu.sd\/?page_id=4057","title":{"rendered":"Clinical Trials Workshop"},"content":{"rendered":"
\n

Clinical Trials<\/h4>\n<\/div>\n
\n

The Mycetoma Research Centre<\/strong><\/p>\n

University of Khartoum<\/strong><\/p>\n

WHO Collaborating Centre on Mycetoma<\/strong><\/p>\n

The Mycetoma Research and Development Arcade<\/strong><\/p>\n

Clinical Trials Workshop<\/strong><\/p>\n

Workshop Overview<\/strong><\/p>\n

Clinical experimental research is necessary to establish the safety and effectiveness of specific health and medical products and practices. Much of what is known today about the safety and efficacy of specific products and treatments have come from randomised controlled clinical trials designed to answer important scientific and health care questions. Randomised controlled trials form the foundation for “evidence-based medicine”, but such research can be relied upon only if it is conducted according to principles and standards collectively referred to as “Good Clinical Research Practice” (GCP).<\/p>\n

This workshop will provide a unique opportunity by giving an overview of this process and type of research study and introduce new and valuable knowledge for researchers in the field. Pioneering researchers and scientists in the field of clinical trials and research will facilitate this workshop and share their knowledge and experience.<\/p>\n

Workshop Facilitators<\/strong><\/p>\n

A group of experts with track records in the design, conduct and analysis of trials in a variety of clinical specialities will facilitate the workshop, and among them:<\/p>\n

    \n
  • Prof Rod Hay, Sudan<\/li>\n
  • Prof Ahmed Hassan Fahal, Sudan<\/li>\n
  • Prof Ahmed Modawi Musa, Sudan<\/li>\n
  • Dr Monique Wasunna, Kenya<\/li>\n
  • Dr Sahar Mubarkh Bakhiet, Sudan, Sudan<\/li>\n
  • Dr Borna Nyaoke, Kenya<\/li>\n
  • Dr Reem Abdulaziz Abdulrahman, Sudan<\/li>\n
  • Dr Eiman Sadig, Sudan<\/li>\n<\/ul>\n

    Learning Objectives<\/strong><\/p>\n

    By the end of the course, participants will have a good understanding of:<\/p>\n

      \n
    • What is a clinical trial<\/li>\n
    • Research Design and Experimental Methodology<\/li>\n<\/ul>\n
        \n
      • Clinical Trial Execution<\/li>\n
      • Good Clinical Practice of clinical trials<\/li>\n<\/ul>\n
          \n
        • Good Laboratory Practice of clinical trials<\/li>\n
        • Ethics in Clinical Research<\/li>\n
        • Independent ethics committee\/ Independent review board<\/li>\n
        • Study protocol and compliance<\/li>\n
        • Patients Recruitment<\/li>\n
        • Roles and responsibilities<\/li>\n
        • Logistics<\/li>\n
        • Good Finance Practice (GFP)<\/li>\n
        • Quality systems<\/li>\n
        • Records keeping<\/li>\n<\/ul>\n

          \u00a0<\/strong><\/p>\n

          Workshop Programme<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
          Date<\/td>\nSession<\/td>\n<\/tr>\n
          Saturday<\/td>\n<\/td>\n<\/tr>\n
          9:00-11:00<\/td>\nIce-breaking<\/p>\n

          Setting workshop objectives<\/p>\n

          Clinical trials introduction<\/td>\n<\/tr>\n

          Tea & Coffee<\/td>\n<\/td>\n<\/tr>\n
          11:30-13:00<\/td>\nDesign of RCT:<\/p>\n

          randomisation, blinding, trial size<\/td>\n<\/tr>\n

          Lunch<\/td>\n<\/td>\n<\/tr>\n
          13:30-15:00<\/td>\nAlternative designs for clinical trials<\/td>\n<\/tr>\n
          Date<\/td>\n<\/td>\n<\/tr>\n
          Sunday<\/td>\n<\/td>\n<\/tr>\n
          9:00-11:00<\/td>\nCertified Good Clinical Practice<\/td>\n<\/tr>\n
          Tea & Coffe<\/td>\n<\/td>\n<\/tr>\n
          11:30-13:00<\/td>\nImportance of Ethics in Clinical Research<\/p>\n

          Participant consent,<\/p>\n

          Data monitoring and when to stop early<\/td>\n<\/tr>\n

          Lunch<\/td>\n<\/td>\n<\/tr>\n
          13:30-15:00<\/td>\nThe roles of Regulatory Affairs in clinical trials<\/td>\n<\/tr>\n
          Date<\/td>\n<\/td>\n<\/tr>\n
          Monday<\/td>\n<\/td>\n<\/tr>\n
          9:00-11:00<\/td>\nCertified Good Clinical Laboratory Practice<\/p>\n

          Introduction to GCLP<\/p>\n

          Organisation & Personnel<\/td>\n<\/tr>\n

          Tea & Coffee<\/td>\n<\/td>\n<\/tr>\n
          11:30-13:00<\/td>\nFacilities, Equipment, Materials & Reagents<\/p>\n

          Standard Operating Procedures & Analytical Plan<\/td>\n<\/tr>\n

          Lunch<\/td>\n<\/td>\n<\/tr>\n
          13:30-15:00<\/td>\nQuality Management<\/p>\n

          Sample Management<\/p>\n

          Data Recording and Reporting<\/td>\n<\/tr>\n

          Date<\/td>\n<\/td>\n<\/tr>\n
          Tuesday<\/td>\n<\/td>\n<\/tr>\n
          9:00-11:00<\/td>\nIntroduction to statistical methods for both design and analysis Principles of design of experiments (randomisation)<\/p>\n

           <\/td>\n<\/tr>\n

          Tea & Coffee<\/td>\n<\/td>\n<\/tr>\n
          11:30-13:00<\/td>\nPower and sample size<\/td>\n<\/tr>\n
          Lunch<\/td>\n<\/td>\n<\/tr>\n
          13:30-15:00<\/td>\nBias reduction (blinding)<\/td>\n<\/tr>\n
          Date<\/td>\n<\/td>\n<\/tr>\n
          Wednesday<\/td>\n<\/td>\n<\/tr>\n
          9:00-11:00<\/td>\nDeveloping a trial protocol<\/td>\n<\/tr>\n
          Tea & Coffee<\/td>\n<\/td>\n<\/tr>\n
          11:30-13:00<\/td>\nReporting: how to write, and critique, a clinical trial report<\/td>\n<\/tr>\n
          Lunch<\/td>\n<\/td>\n<\/tr>\n
          13:30-15:00<\/td>\nGroup Work<\/td>\n<\/tr>\n
          Date<\/td>\n<\/td>\n<\/tr>\n
          Thursday<\/td>\n<\/td>\n<\/tr>\n
          9:00-11:00<\/td>\nClinical trials in practice<\/p>\n

          key steps in the logistical and practical implementation of a clinical trial<\/p>\n

          patients recruitment<\/td>\n<\/tr>\n

          Tea & Coffee<\/td>\n<\/td>\n<\/tr>\n
          11:30-13:00<\/td>\nTrial governance and approvals<\/p>\n

          Monitoring and Auditing<\/td>\n<\/tr>\n

          Lunch<\/td>\n<\/td>\n<\/tr>\n
          13:30-15:00<\/td>\nData processing<\/p>\n

          Data management<\/td>\n<\/tr>\n

          Date<\/td>\n<\/td>\n<\/tr>\n
          Saturday<\/td>\n<\/td>\n<\/tr>\n
          9:00-11:00<\/td>\nGood Finance Practice GFP<\/p>\n

          The key features of the Good Financial\u00a0 Practice<\/td>\n<\/tr>\n

          Tea & Coffe<\/td>\n<\/td>\n<\/tr>\n
          11:30-13:00<\/td>\nFinancial management and internal controls<\/p>\n

          Procurement<\/p>\n

          Governance<\/td>\n<\/tr>\n

          Lunch<\/td>\n<\/td>\n<\/tr>\n
          13:30-15:00<\/td>\nFeedback \u2013 Certificates<\/p>\n

          Closing ceremony<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

          \n

          Instruction Methods<\/strong><\/p>\n

          This workshop is a hands-on training activity with various interactive instructional techniques. There will be brief presentations, with many small group teaching, discussions and presentations. It will include many online sessions with international experts in the field. A 30-minute optional drop-in session at the end of each day where students can ask any remaining questions one-on-one with tutors will be organised. There will be many homework assignments and groups presentations. Case studies and Sharing experience session will be included in the workshop.<\/p>\n

          Who Should Attend<\/strong><\/p>\n

          The target attendees are all medical and health professionals, clinical research professionals, research managers, and other scientists who share an interest in the field of clinical trials and experimental research.<\/p>\n

          Workshop Duration<\/strong><\/p>\n

          It is a six-day intensive workshop tackling different domains in clinical trials conduction and procedures.<\/p>\n

          \u00a0<\/strong><\/p>\n

          Workshop Coordinator<\/strong><\/p>\n

          Dr Eiman Saddig will coordinate the workshop<\/p>\n

          How will the assessment be done<\/strong><\/p>\n

            \n
          • Pre-workshop MCQs to assess the basic knowledge of participants prior to the sessions<\/li>\n
          • Interactive sessions<\/li>\n
          • Post-workshop MCQs to assess the acquired knowledge and certificate will be handed after achieving the minimum pass score. Those who fail to achieve this score will be offered a second attempt to take the following workshop’s post-workshop assessment.<\/li>\n<\/ul>\n

            Workshop Evaluation<\/strong><\/p>\n

            Oral and written participants and workshop facilitators feedback will be obtained<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

            Clinical Trials The Mycetoma Research Centre University of Khartoum WHO Collaborating Centre on Mycetoma The Mycetoma Research and Development Arcade Clinical Trials Workshop Workshop Overview Clinical experimental research is necessary to establish the safety and effectiveness of specific health and medical products and practices. Much of what is known today about the safety and efficacy […]<\/p>\n","protected":false},"author":9,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4057","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/pages\/4057","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4057"}],"version-history":[{"count":1,"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/pages\/4057\/revisions"}],"predecessor-version":[{"id":4058,"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/pages\/4057\/revisions\/4058"}],"wp:attachment":[{"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4057"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}