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.
- 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...