• Describe the ICH GCP protocol including FDA 21 CFR, E2A, 5,5 E6, and Ethics
• Explain the Quality Monitoring process including designing trials, site visits, monitoring visits, close out
visits, protocols, and reporting violations.
• Outline the process and professional roles involved in audit and inspections.
• Appropriately detect and report misconduct and fraud.
• Apply concepts of clinical research roles in a multiple choice examination.
- Provider:Postgraduate Institute for Medicine
- Activity Link: https://app.ccrps.org/
- Start Date: 2023-09-08 05:00:00
- End Date: 2023-09-08 05:00:00
- Credit Details: AMA PRA Category 1 Credit™️: 17.5 hours
Nursing: 17.5 hours
Pharmacy: 17.5 hours - Commercial Support: No
- Activity Type: Enduring Material
- CME Finder Type: Online Learning
- Fee to Participate: Yes
- Measured Outcome: Learner Knowledge, Learner/Team Competence
- Provider Ship: Jointly Provided
- Registration: Open to all
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