Good Clinical Practices

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

This course is part of the following Certificate Program(s):

• Clinical Trials Design and Management

• Regulatory Affairs Essentials

• Regulatory Affairs for the Biomedical Industry