BIOT 360 - The Fundamentals of Clinical Research

Units: 4

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.