The National Institutes of Health (NIH) defines clinical research as "patient-oriented research, including epidemiologic and behavioral studies, outcomes research, and health services research."

Clinical trials

The process for submission of an industry-sponsored clinical trial is significantly different than for a standard grant or contract. Good sources of information related to clinical trials are the Clinical Research Handbook, the Human Subjects Division webpage on Clinical Trials and the Office of Research webpage on Industry Clinical Trials.

Review of these sites should be the first step for all investigators who may be contemplating conducting their first clinical trial.

Clinical research is also funded through federal funding. Information on submitting proposals and obtaining human subjects’ approvals can be found on the websites above or from your division administrator.

How do I find study participants?

Participate in Research is a website that connects research study teams to members of the community. Researchers from the University of Washington and other institutions can post their research studies to the site, and potential volunteers can search for studies that apply to them. The website is sponsored by the Institute of Translational Health Sciences (ITHS) and the UW School of Medicine.

Billing

Professional services

As a School of Medicine faculty member, you must fully account for your professional services in clinical research. 

The methodology for accounting for professional services varies depending on the: 

  1. Type of study
  2. Type of service
  3. Type of personnel

If you are the principal investigator or key personnel, you must account for your professional services as:

  1. Effort on a grant or contract, or
  2. Professional fees charged to a patient/subject or third party payer

Clinical Research Budget & Billing (CRBB)

CRBB is the centralized clinical research budget and billing support office for UW Medicine faculty and staff. They help clinical researchers and collaborators create sound financial plans that deliver the right bill for the right amount to the right payer at the right time.

For industry sponsored studies, the Office of Sponsored Programs (OSP) will not finalize and sign your Clinical Trial Agreement without an email from CRBB that indicates a budget review has taken place. For all studies involving patient care services, you will not receive a study RRR account until CRBB review has occurred.

Submitting your study

Submission requirements vary depending on the funding source (industry or non-industry). Please review the online checklists at the CRBB website.  

When can I see patients?

  1. After the budget is finalized
  2. The Billing Grid is signed
  3. The IRB has issued approval
  4. Study funding has been secured
  5. RRR hospital research account has been established (the RRR account is the mechanism in Epic that creates a billing pathway for study-billable charges)

Required training

  1. Faculty Clinical Trials Policy (CTP) training for faculty is required before CRBB can assign an RRR account for a study
  2. School of Medicine Clinical Research Effort Policy training

Human Subjects

Patient-oriented research is conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which a researcher directly interacts with human subjects. 

Review and approval by the Institutional Review Board (IRB) or the Human Subjects Division (HSD) is required before starting research involving human subjects. Please contact the UW Human Subjects Division (HSD) or visit their website for more information.