Clinical Research Compliance and Education

Overview & Instructions

The Clinical Trials website is designed to aid you in the startup, performance, and closeout of a clinical trial at the University of Utah. Within the website you will find budgeting tools, guidance concerning University of Utah policies surrounding clinical trials, and links to regulatory, administrative, and financial offices.

When preparing for a clinical trial, there are typically many tasks which must be performed before patient enrollment can begin:

  • Confidential Disclosure Agreement (if required by sponsor) must be reviewed and signed by the University of Utah Technology Transfer Office.

  • Principal Investigator (PI) must review protocol and determine interest in performing study.

  • PI and staff may meet with sponsors or conduct site visits.

  • PI and staff must develop and negotiate budget.

  • Office of Sponsored Projects must negotiate study agreement/contract

  • PI and staff must apply for and obtain IRB approval

Throughout the length of the clinical trial, you will likely have questions related to the ongoing financial and regulatory requirements surrounding clinical trials. Please review the various sections of this website for guidance or refer to the contact information.