THE UNIVERSITY OF CALIFORNIA DAVIS HEALTH SYSTEM
Health System Contracts, Clinical Trials
INSTRUCTIONS: Deliver/mail Completed form to Health System Contracts, Clinical Trials,
Sherman Building, Room 2300, 2315 Stockton Boulevard. Departments are responsible for
monitoring accounts established in advance of receiving formal award.
REQUEST TO EXPEND FUNDS PRIOR TO AWARD
Principal
Investigator:
Project Title:
Sponsor:
As Principal Investigator, I
certify that no federal or
state funds are being
provided by Sponsor for this
project.
Department:
Protocol Number
As Principal Investigator, I certify that no human
subject, animal subject, and/or environmental
health and safety approvals are necessary for the
work to be performed using the funds authorized
for use by this document.
Name and Phone Number of
Sponsor Contact:
Total Start-up fee Amount (including applicable
indirect costs):
$
I understand that the funds noted above and as indicated in the attached budget are intended only for
up front and administrative costs needed to prepare for the clinical trial indicated above, and not for
the performance of the trial itself, until such time as a fully executed clinical trial agreement is
approved by Health System Contracts and all regulatory requirements are met.
Principal
Investigator:
Date
I certify that department funds will be available to cover expenditures incurred under this account until
such funds are received from the Sponsor. (Indicate alternate fund source below.)
Department (or Dean, if applicable) fund
source:
Department Chair:
Dean of the School of
Medicine:
Date
Date
Health System Contracts has received documentation sufficient to begin negotiation of a clinical trial
Agreement with the Sponsor as identified above.
Director, Health System
Contracts:
Created 10/1/2009 for Health System Contracts
Date
Principal Investigator:
Department:
Project Title:
Sponsor:
Protocol Number:
START-UP COSTS BUDGET
Protocol
ITEM
Complete Feasibility Questionnaire from Sponsor
Review protocol & study flow
Review by Scientific Review Committee (for cancer studies)
Preparation and return of Sponsor/Site documents
Pre-Study Site Selection visit, prepare for & attend
Prepare, distribute, collect and copy financial disclosures
Obtain and copy CV's
Preparatory Research
CMS determination
Budget
Prepare the study budget
Set up accounting & billing (DaFIS and Bulk) for study procedures
IRB Documents
Informed Consent form, write, review and/or revise
Protocol and Investigator's Brochure Review
Prepare & Deliver IRB documents
Follow up discussion with IRB reviewers / document revision
Prepare docs for chairman signature, deliver & pick up
Radiation Safety, Biological safety
Scientific Review Committee, Obtain Approval
Training
Train Staff for Study/Certification
Pharmacy
Correspondence with Pharmacy
(pharmacy fee included below)
Communications
Correspondence with Sponsor reps
Case Report Form Review
Initial Investigator Meeting, Prepare and Attend
Coordinator
$
Salaries
Total
0
0.00
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PI (optional)
Co-PI (Optional)
Site Mgr/RN (Optional)
$
$
$
0
0
0
0.00
0.00
0.00
QA Mgr (Optional)
$
0
0.00
0.00
Other Start-up fees
Database design and Maintenance
Data Analysis/Biostat
CRF design
Advertisement/recruitment fee
Office Supplies
Document Storage
Phones
Duplication
Mailing
Translation of Informed consent
Pharmacy Fees
Total
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Subtotal
Indirects at 26%
$0.00
$0.00
Total Start-Up Fee
$0.00
IRB Fee (Initial)
$3400.00
As an authorized representative of the Sponsor I hereby agree to the following:
-Sponsor shall provide a non-refundable payment equal to the IRB Fee (Initial) amount listed above to the address
indicated below upon execution of this Start-Up Costs Budget.
-Sponsor shall provide a non-refundable payment equal to the Total Start-Up Fee amount listed above no later than
upon execution of the Clinical Trial Agreement or upon invoice by the University if no agreement is reached.
-Checks shall be made payable to the Regents of the University of California and shall be sent to the address below:
___________________________________
___________________________________
___________________________________
-I acknowledge that these funds are intended to cover the administrative and regulatory costs of preparing for a
clinical trial at the University of California Davis Health System. I acknowledge and agree that no clinical activity
involving patients will begin unless and until a Clinical Trial Agreement if fully executed by the Regents of the
University of California on behalf of its University of California Davis Health System.
Sponsor Signature:
Date:
Name:
Title:
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