Federally Sponsored Clinical Research

Clinical Trials Definition

Clinical trials are one of the two main types of clinical studies (the other being observational studies).  In October 2014, in order to more clearly distinguish between clinical trials and clinical research studies, the National Institutes of Health (NIH) revised its definition of a clinical trial as follows: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.  This revised definition will apply to competing grant applications and contract proposals that are submitted to NIH on or after January 25, 2015.

For more information about the NIH clinical trials definition, including a decision tree and case studies, visit the NIH page on clinical trials. For more information on clinical studies in general or to search for a clinical study, visit ClinicalTrials.gov.

Submitting Proposals

All federally-sponsored clinical trial proposals must be processed through OSR. Procedures for OSR processing include completing an InfoEd Proposal Development (PD) record, which includes obtaining administrative approvals and satisfying all other compliance requirements. Review by the department chair and administrative personnel is essential to ensuring that the University can provide the space and resources needed to conduct the project. No study subject related activity can be initiated until appropriated IRB approval has been obtained and either a Notice of Grant Award is received or a subcontract agreement has been executed by OSR.

Budget tips for Federally-sponsored Clinical Trials

  • F&A rate: The Federal sponsored research rate is applicable.  The on-campus or off-campus rate should be used as applies to the project.
  • IRB fees: IRB fees are not charged to Federally-sponsored projects.
  • Per patient rates: If a per patient rate is provided, F&A must be backed out of the per patient rate.
  • Multisite trials: If Northwestern University is the prime site for a proposed multisite trial, complete subcontractor information from all sub-sites must be submitted to NIH with the initial application.

Investigational Drug Service (Research Pharmacy) Fee Structure

(as of September 1, 2014)

STUDY DOSING FEES
INDUSTRY SPONSORED
NON-INDUSTRY SPONSORED*
Prescription
$50 / prescription
$15 / prescription
IV
$100 / dose – low
$250 / dose - high
$45 / prescription
OPERATING FEES
INDUSTRY SPONSORED          
NON-INDUSTRY SPONSORED*
Initiation *
$3,000
$300
Annual Maintenance
 
 
High
Medium
Low
$1,000
$700
$300
$50
Drug Compounding 
$60/hour
$30/hour

* As of December 1, 2014, ALL projects will be directly charged the new initiation fee rates.

Northwestern University - Office for Research

Contact :
Chicago
Arthur Rubloff Building
750 N. Lake Shore Dr., 7th Floor
Chicago, IL 60611
Phone: (312) 503-7955
OSR-Chicago@northwestern.edu
Evanston
1801 Maple St.
2nd Floor, Suite 2410
Evanston, IL 60201-3149
Phone: (847) 491-3003
OSR-Evanston@northwestern.edu