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
|01/20/14 - 03/18/14 (Click to show details)||Online||099019||$395.00||Closed|
|04/14/14 - 06/10/14 (Click to show details)||Online||100780||$395.00||Add to Cart|