This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; and the roles and responsibilities of investigators, sponsors, monitors, and auditors.
“Online self-paced”: Refers to course start and end dates. “Online fixed date”: Refers to synchronous session schedule fully available under “Section Notes”.
Applies Towards the Following Certificates
- Clinical Trials Management and Regulatory Compliance : Required Courses