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Programme Fundamentals Of Clinical Research :

  1. Operating context and glossary of the Clinical Trial.
  2. Good Clinical Practice and main national and international legislation.
  3. Clinical Trial Methodology: classification, phases and designs of Clinical Trials; structure and meaning of the Study Protocol.
  4. Ethical aspects of the Clinical Trial, protection of the Study subjects and informed consent.
  5. Clinical Monitoring: on site and remote monitoring activities of the Clinical Monitor.
  6. Quality management systems: quality assurance and quality control.
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