Full course description
The sponsor of a clinical research study is responsible for quality assurance throughout all stages of the trial process by ensuring trials are adequately monitored. The purpose of monitoring is to ensure:
- Human subject protection: The rights and well-being of human subjects are protected.
- Reliability of trial results: The reported trial data are accurate, complete, and verifiable from the source documents.
- Compliance with the current Institutional Review Board (IRB) approved protocol/amendment(s), with International Council for Harmonization (ICH) Good Clinical Practice (GCP), and with applicable regulatory requirements.
Externally sponsored clinical research studies are studies sponsored by an entity other than the University of Utah. All externally sponsored studies are subject to monitoring by the sponsor. The sponsor may delegate some or all of the quality oversight to a Clinical Research Organization (CRO).
The Principal Investigator (PI) is required to make available the requested trial-related material for the monitor, auditor, or regulatory authorities.