This introductory course describes the role and responsibilities of CRAs and their job function through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations pertinent to clinical monitoring. The content for this course focuses on drugs and biologics development.
Key Topics
• Good Clinical Practices (GCP)
• Regulatory requirements for clinical research
• Clinical research methodology and its role in drug development
• CRA's role in clinical research
• Monitoring clinical trials to ensure valid and useful study data
• Investigator selection and evaluation
• FDA audits
• Basic HIPPA requirements
• Basic protocol development.
Key Topics
• Good Clinical Practices (GCP)
• Regulatory requirements for clinical research
• Clinical research methodology and its role in drug development
• CRA's role in clinical research
• Monitoring clinical trials to ensure valid and useful study data
• Investigator selection and evaluation
• FDA audits
• Basic HIPPA requirements
• Basic protocol development.
