Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements 2017

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Course "Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

  • Defining the basic requirements of Good Clinical Practices
  • Clinical Study Protocol Elements and Device Accountability
  • Role of Institutional Review Board (IRB) and Informed Consent
  • Principles of Ethics and Quality Control
  • Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial
  • Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials
  • Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection
  • Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials
  • And Much More...