Clinical Trials

Resources

• UW Office of Clinical Research
• Clinical Research Budget & Billing Support Office (CRBB)
  • CRBB Toolkit
  • CRBB Training Series
• Industry-Sponsored Clinical Trials Administrative Start-Up Handbook, School of Medicine
• FDA Office for Good Clinical Practice
• Resource Centers and Facilities. A listing of the UW School of Medicine Centers, Laboratories, and Core Facilities available to basic and clinical researchers, internal and external to UW Medicine.
• Health Sciences Research Subjects Recruitment Website
• ClinicalTrials.gov - Linking Patients to Medical Research
• Standard Operating Procedure Templates
• School of Medicine Clinical Trials Discussion Group
• Industry Agreements

Policies

• Indirect Cost Policy for Clinical Trials
• IRB Review Fee for Industry Sponsored Clinical Trials
• Significant Financial Interest Disclosure Policy
• Ban on Finders Fees
• Policy Prohibiting Enrollment Incentives
• FDA Clinical Investigator Inspections
• FDA Inspector Manual
• Implant and Investigational Device Committee - Section 9 of the Clinical Trials Administrative Startup Handbook. A review by the IIDC is required for clinical trials involving medical devices.

Forms

• Pre-Clinical Trial Nondisclosure Agreement Form
  • Delegation of Authority
• Sample Consent Form for Industry-Sponsored Clinical Trials
• Consent Forms and the Process of Obtaining Informed Consent