Topics include the definition and identification of good clinical practices (GCPs); how GCPs affect the conduct of clinical trials; regulating agencies and applicable regulations from the Code of Federal Regulations and ICH guidelines; state regulations; obligations of investigators, sponsors, monitors, and IRBs; compliance and accountability during clinical trials; protocol violations and deviations; consequence of falsification of data and/or patient records; and the blacklist. Device regulations also covered.
Note: No textbook required. Requirement for Professional Certificate in Clinical Trials Design and Management.
Other Credit: BRN: 24 CE hrs.
Course Number: FPM-40204 Credit: 3 units