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.
COURSE HIGHLIGHTS
鈥ood Clinical Practices (GCP)
鈥egulatory requirements for clinical research
鈥linical research methodology and its role in drug development
鈥RA's role in clinical research
鈥onitoring clinical trials to ensure valid and useful study data
鈥nvestigator selection and evaluation
鈥DA audits
鈥asic HIPAA requirements
鈥asic protocol development.
COURSE HIGHLIGHTS
鈥ood Clinical Practices (GCP)
鈥egulatory requirements for clinical research
鈥linical research methodology and its role in drug development
鈥RA's role in clinical research
鈥onitoring clinical trials to ensure valid and useful study data
鈥nvestigator selection and evaluation
鈥DA audits
鈥asic HIPAA requirements
鈥asic protocol development.
