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.