Information for Investigators/Study Coordinators Overview

Clinical Trials being conducted at KU Medical Center

Clinical Research Policies

Effective January 2, 2006: All human subject cancer or cancer-related protocols (therapeutic/treatment, prevention, ancillary/companion and correlative), must be reviewed, approved, and monitored by the Kansas Masonic Cancer Research Institute's Protocol Review and Monitoring Committee (PRMC). PRMC approval must be obtained prior to the Principal Investigator beginning the submission process to the Human Subjects Committee (HSC). Monitoring of the ongoing research will take place after all compliance approvals have been completed.

Scientific Review and Monitoring of Cancer or Cancer- Related Protocols and Research Policy (PDF)

Investigational Drug Dispensing

• Hospital Department of Pharmacy investigational drug dispensing procedure
• Kansas Pharmacy and Related Laws

Investigation Device Exemptions (IDE)

• IDE Background information
• IDE Application

Investigational New Drug (IND) Information

• What is an IND? (PDF)
• Frequently Asked Questions Regarding IND's and IND filing
• Sample cover letter for IND filing (MS Word)