Human Subjects Research Training: Clinical Trials and Good Clinical Practice (GCP)
Personnel Type |
Working with... | CITI Training Name | Protocol Requirement? |
---|---|---|---|
Faculty, Staff, or Students | Social sciences clinical trial | IRB GCP for Social and Behavioral Research Best Practices in Clinical Research | Required add-on if protocol meets the definition of a clinical trial |
Faculty, Staff, or Students | FDA funded clinical trials involving investigational drugs or medical devices | IRB GCP for Clinical Trials with Investigational Drugs and Medical Devices (FDA Focus) | Required add-on if protocol meets the definition of a clinical trial |
Faculty, Staff, or Students | Drugs and biologics clinical trial work subject to the regulations of the International Council for Harmonisation (ICH) | IRB GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) | Required add-on if protocol meets the definition of a clinical trial |
Faculty, Staff, or Students | New device clinical trial | IRB GCP for Clinical Investigations of Devices | Required add-on if protocol meets the definition of a clinical trial |