Industry Clinical Trials
Setting up and conducting industry sponsored clinical trials involve several steps and multiple offices.
Review the Clinical Trials Handbook for practical information, guidance and resources on setting up and conducting clinical trials as well as other vital clinical research information.
More information on plan/propose industry sponsored clinical trials.
Clinical Trials: UW Budget Set Up
To use sponsor funds for an industry funded clinical trial, you will need:
- An approved budget
- IRB approval
- Significant Financial Interest (SFI) review complete
- Fully-executed clinical trial agreement
The University of Washington (UW) Clinical Research Budget and Billing Office (CRBB) reviews the billing plan, and negotiates and finalizes the budget for your industry sponsored or industry initiated clinical trial. Once final, CRBB provides the summary review to the Principal Investigator and forwards a copy to the Office of Sponsored Programs (OSP). OSP will attach the approved budget to your eGC1.
The UW requires most all industry clinical trials to be reviewed by the independent Institutional Review Board (IRB) called WIRB instead of the UW IRB. Obtain the authorization to send a trial to WIRB by using the UW’s Zipline e-IRB system and following the instructions: Create an External IRB study. PIs who are members of the local Cancer Consortium may choose to send their applications to the Fred Hutchinson Cancer Research Center IRB instead of WIRB, using the same process. For all industry trials, the PI is responsible for ensuring that the consent form, clinical trial agreement, and trial budget are consistent with each other regarding: who is paying for what (procedures, subject injuries), and who will have access to the identifiable data.
Significant Financial Interest (SFI) Review Complete
Investigators must disclose their significant financial interest via the UW Financial Interest Disclosure system (FIDs). The Office of Research reviews disclosures for Financial Conflict of Interest and determines if a conflict management plan is required. If necessary, a conflict management plan is issued before OSP releases funding.
Fully-executed Clinical Trial Agreement
OSP negotiates the agreement for consistency with UW policies. Once both OSP and the sponsor have signed the agreement, it is attached to the Funding Action associated with the eGC1.
Agreement negotiation happens at the same time as the budget, IRB and SFI are reviewed. When all are final, OSP release the Funding Action to Grant and Contract Accounting (GCA) for UW budget number set-up.
Federally Funded Clinical Trials
Funding for clinical trials is available from federal agencies. This funding may be through federal grant funding or contract. See federal sponsor requirements for more details.
Forms, Tools, and Resources
- Human Subjects Division (HSD)
- Advance Budget Request Eligibility Tool
- UW Advancement: Working with Corporations
- UW Medicine Clinical Research Budget and Billing (CRBB)
- ClinicalTrials.gov Registration
- UW Medicine Clinical Research
- Master Clinical Trial Agreements
- Agreement Types
- Clinical Research Handbook
- Plan/Propose: Industry Clinical Trials
- Office of Sponsored Programs
- Pre-Clinical Trial Nondisclosure Agreement (NDA)