Good Clinical Practice Training
Duration: 15 CPD Hours
Good Clinical Practice course description:
Desgined for those that work in the health care industry across organisations (Pharmaceutical/Biotech/CRO's/Hospitals) for investigators, nursing and any other staff involved in clinical trials. This course is the most comprehensive available. It has an estimated completion time of 15 hours.
Elements covered in this GCP course:
- GCP A Historical Perspective
- Nuremberg Code
- The Declaration of Helsinki
- Belmont Report Ethical Principles
- Good Clinical Practice
- Medicines for Human Use Clinical Trial Regulation 2004
- Clinical Trials Directive on Good Clinical Practice
- Good Clinical Practice Directive (2005/28/EC)
- GCP - The 13 Principles
- ICH GCP and FDA
- Source Data
- Informed Consent Process
- Ethics Committees and Submissions
- IRB's & Submission process (USA)
- ICH Responsibility of Investigator
- Responsibility of Sponsor
- Essential Documents for a Clinical Trial
- Adverse Events
- Serious Adverse Events
- Unexpected Adverse Events
more...
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