ppap
Platform Orchestrator
2
MONTHS
2 2 MONTHS OF SERVICE
LEVEL 1
400 XP
- Articulate the definition, purpose, and historical context of GCP.
- Explain the importance of GCP in protecting human subjects and ensuring data integrity.
- Identify key international organizations involved in establishing GCP standards.
- Apply ethical principles and informed consent procedures in clinical research.
- Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
- Design and conduct clinical trials according to ICH E8 and E9 guidelines.
- Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
- Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.
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