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 and Award 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

Approved Budget

The University of Washington UW Clinical Trials Office (CTO) reviews the billing plan and negotiates and finalizes the budget for your industry sponsored or industry initiated clinical trial. Once final, CTO 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 Award Setup or Modification Request.

IRB approval

The UW requires almost all industry clinical trials to be reviewed by any of these IRBs instead of the UW IRB: WCG IRB, Advarra, or (for oncology trials) the Fred Hutchinson Cancer Center IRB. Obtain the authorization to send a trial to one of these IRBs by using the UW’s Zipline e-IRB system and following the instructions: How to ask for a Non-UW IRB.

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 Award Setup Request associated with the eGC1.

Agreement negotiation happens at the same time as the budget, IRB and SFI are reviewed.  When all are final, OSP releases the Award Setup Request to Grant and Contract Accounting (GCA) for UW Award set-up in Workday.

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.