Introduction:
Faculty members within the University of Washington (UW) Health
Sciences areas participate with pharmaceutical and biotechnology companies
in a
wide range of clinical studies. Most of these studies are in the form of
clinical trials to test the safety and efficacy of investigational drugs
and devices under a sponsor - developed protocol. While clinical studies
constitute only a small component of the overall UW research programs,
they provide a valuable point of contact between the academic and industrial
research communities in addition to providing a public service through
providing unbiased review as part of the FDA approval process.
We have prepared
this guide for internal use by faculty
and staff members who administer clinical
trials.
Step-by-step Checklist
1. The Principal Investigator submits proposal with
a GC1 form to OSP when participation in a
clinical study appears likely.
2. OSP reviews proposal and obtains any
necessary additional information.
3. OSP signs proposal and sends
it to Sponsor
4. OSP begins any necessary negotiations with sponsor. UW TechTransfer
reviews intellectual property provisions which depart from standard
UW language.
5. Sponsor and OSP sign agreement, Sponsor
forwards payment.
6. OSP, through a Notice to Establish
Account (NEA), authorizes Grant and
Contract Accounting (GCA) to assign
an account (budget) number for the
project.
Clinical Study Agreement Budget Instructions
- Submit a completed budget
on the GC1 form to the Office
of Sponsored Programs (OSP)
along with the clinical study
proposal package. If the Sponsor
has its own form for budget
information, complete that
document and submit it to
OSP as well.
- Salaries should be
calculated against the University
base salary received by the
individual. For example, if
the University yearly base
salary of a PI is $80,000
and the PI anticipates that
10 percent of his/her time
will be spent on the project
for the year, then a maximum
of $8,000 could be budgeted
for the salary of the PI for
the year. This would be paid
as part of the faculty member's
base salary and not as excess
compensation. Refer to Grants
Information Memorandum (GIM)
25 for the provision for estimated
salary increases.
- Benefits should be
based on the most current
cost projections provided
by GIM 3.
- Patient Care includes
tests and services billed
through the UW Medical Center
or through the clinics of
the School of Dentistry. Patient
tests conducted in a UW laboratory
that are not included in the
hospital billing should be
listed under "Other Expenses."
- Equipment is defined
as an item costing $2,000
or more, and that has a life
expectancy of 1 year or more.
- Indirect Costs for industry sponsored, fixed price clinical
trials should be budgeted at the rate of 25% of Total Direct Costs.
Clinical Study Agreement Budget
Protocol No. 
Period beginning and
ending
SALARIES Subtotal $
BENEFITS Subtotal $
SUPPLIES Subtotal $
PATIENT CARE Subtotal $
EQUIPMENT Subtotal $
OTHER EXPENSES Subtotal $
Direct Cost Subtotal $
Indirect Cost $
TOTAL COST $
Number of subjects:
Cost
per subject: $
This form is for internal use only. It is not meant to replace budget
forms required by sponsor.
After a Clinical Study Agreement has been signed,
notify OSP if:
- A subject experiences an adverse
effect
- The study is terminated
early
- More time is needed to finish
the study
- The number of subjects specified
in the agreement changes
- The Sponsor is late in making scheduled payments.
For More Info
The staff of the UW Office of Sponsored Programs looks forward
to serving you and welcomes your suggestions and questions in writing,
by phone, or in person. Contact OSP.
