What is a clinical trial?
Definition of an Industry-Sponsored Clinical Trial
A Clinical Trial (CT) explores the safety and efficacy of a medical strategy, treatment, drug or device for humans. These studies may also show which medical approaches work best for certain illnesses or groups of people. Clinical Trials produce information that help patients and their health-care providers make better health–related decisions.
At Stanford, industry-funded Clinical Trials are a subset of clinical research and qualify for a CT-specific indirect cost rate. Clinical research studies that do not qualify as Clinical Trials receive the applicable federally negotiated Facilities and Administrative (F&A) rate.
Who negotiates agreements for Clinical Trials in the School of Medicine (SoM)?
A subgroup within the Research Management Group, the Clinical Trial Research Management Group (CT RMG) negotiates clinical trial agreements, related agreements, and clinical trial budgets specifically with industry funders. In order to qualify for the industry-funded clinical trial rate at Stanford, the study must meet the definition of a clinical trial provided in the Research Policy Handbook Section 13.3.
The RPH defines a Clinical Trial as a study that is:
- funded by a for-profit company;
- performed in clinical, off-campus space;
- involves human subjects; and
- tests a drug, device, diagnostic, treatment, intervention or preventative measure; or involves collection or review of human subject data acquired in a clinical setting to increase knowledge that will lead to enhanced safety and efficacy of the test item.
CT RMG uses the definition above to determine the applicable F&A (or Indirect Cost) rate. If a study meets the definition of a Clinical Trial, CT RMG has authority to negotiate, review and approve the budget and agreements. For cancer focused Clinical Trials, the Cancer Center Clinical Trials Office (CCTO) negotiates the budget and a CT RMG manager reviews and approves the budget prior to contract signing. A Clinical Trial Contract Officer (CT CO) negotiates agreements directly related to industry-sponsored clinical trials, such as Nondisclosure Agreements, Clinical Material Transfer Agreements, and Equipment Loan Agreements.
Studies that do not meet the RPH definition of an industry-sponsored Clinical Trial may be negotiated by the Office of Sponsored Research (most government or non-profit funded studies) or the Industrial Contracts Office (industry-sponsored clinical research projects).
This website provides a listing of the various central offices at Stanford and the types of agreements they negotiate.
How we determine if your project is a Clinical Trial
Minimum documents should be submitted to CT RMG Intake. Upon receipt, CT RMG Intake reviews the documents to answer the following questions:
- Who is the sponsor?
- Is the sponsor a for-profit company or a government agency or a non-profit entity?
- What is the purpose of the study?
- Does it involve human subjects or human subjects data?
- Where is the study being performed?
New Study Set up Process: SeRA CT PDRF
Stanford Internal Resources
- Definition of a Clinical Trial at Stanford
- Definition of Clinical Research
- Cancer Clinical Trials Office (CCTO)
- Industrial Contracts Office
- Office of Research Administration
- Clinical Trials being conducted at Stanford hospitals and clinics
- Coverage Analysis Memo
- Coverage Analysis FAQ
- Coverage Analysis Process & Procedure Training
External/Agency Specific Resources
Spectrum Clinical Research Operations Program (with Certification)