M E M O R A N D U M
 
 

TO:    Prospective GCRC Investigator

FROM:   Thomas A. Buchanan, M.D.

                  Program Director, GCRC

                  226-4632, buchanan@hsc.usc.edu

DATE:  May 2, 2006

SUBJECT :   Cost Estimates for Industry-Initiated and/or Sponsored Protocols 
 

The primary purpose of the General Clinical Research Center is to provide a clinical research infrastructure to investigators who receive their primary research funding from the NIH, or whose research has the potential to lead to NIH funding.  In addition, the GCRC may host investigations funded by other federal, state and local agencies, and by the private sector.  

If the GCRC assists in the performance of projects that are sponsored by pharmaceutical companies, the investigator is expected to pay for the use of the GCRC facilities at the same rates it would pay for any other hospital services.  The investigator may request these funds from the sponsoring agency at the time he/she is preparing the project budget.

To obtain an estimate of the cost of performing your study on the GCRC, complete the attached Cost Estimate Form and return to the GCRC @ GNH 6602.  Please remember to attach the protocol detail to the form. 

Based on the assumption a patient’s chemotherapy is being paid for by either his/her own insurance or some other third party payer, the GCRC will NOT be held responsible for the payment of these medications

We will make every effort to provide you with a cost projection within ten working days of the submission, provided that a representative of your project is available to answer questions about the services requested.

PLEASE NOTE: THIS APPLICATION SHOULD BE COMPLETED AT THE TIME YOU ARE PREPARING THE BUDGET FOR YOUR PROPOSAL SO THAT YOU MAY REQUEST THE APPROPRIATE FUNDS FROM THE SPONSORING AGENCY.

If you have any questions regarding the cost estimate process, please contact me or Denise Walters, Administrative Director, either by email (buchanan@usc.edu , dwalters@usc.edu ) or phone 323/226-4632.

PRINCIPAL INVESTIGATOR:  ________________________________________

CONTACT (IF NOT THE PI):  ________________________________________

DEPARTMENT: ____________________________________________________

PHONE NO: ________________________FAX NO: _________________________

TITLE/IRB #: __________________________________________________________

______________________________________________________________________
 

I.  THIS PROTOCOL IS (circle one):

A.   Fully investigator-initiated. 

Note:  Prior to the start-up of this study on the GCRC, you will need to provide the following: 

Documentation from the sponsor indicating you initiated the study
If this is a multi-center study, documentation from the sponsor indicating you initiated the study.
Documentation from the sponsor indicating you have full publication rights
 

Industry-initiated; developed and proposed by a pharmaceutical-sponsor and not related to the investigator’s projects or programs.
 

II.  PLEASE ATTACH A COPY OF THE PROTOCOL DETAIL.  

PLEASE NOTE:  Our final price will be determined after the physician’s orders are developed, including all nursing tasks, LAC labs, GCRC lab processing instructions, dietary requirements and any ancillary services.  To enable us to give you an accurate estimate, please provide as much of this information as possible on this form. 

Based on the assumption that the patient’s chemotherapy is being paid for by either his/her own insurance or some other third party payer, the GCRC will NOT be held responsible for the payment of these medications.  
III. COMPLETE FOR INPATIENT STUDIES (inpatient = patient in hospital bed at 12 midnite)

Length of hospitalization: ______________ days (inpatient)
 

Patient Care Activities (i.e., VS, drug administration, blood draws, weight, height, pt teaching)
 

________________________________________________________

List day-to-day GCRC procedures: ____________________________________________________________________________
 

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________
 

Equipment needed for protocol (i.e., # and type of infusion pump, Dinamap, EKG Monitor:
 

____________________________________________________________________________

  &nbs