The Fundamentals of Clinical Research

Catalog description

Teaches the basics of clinical management and implementation of good clinical practices. Focuses on regulating agencies and applicable regulations from the Code of Federal Regulations and ICH guidelines; state regulations; obligations of investigators, sponsors, monitors, and IRBs; the consequence of falsification of data and/or patient records; the blacklist; compliance and accountability during clinical trials; and risk management and quality control, protocol violations and deviations. Emphasizes the Good Clinical Practice (GCP) framework and GCP for individual clinical trials and quality in clinical trials. Prerequisite(s): BIOT 257 .