GUIDELINES AND FEES FOR INDUSTRY SPONSORED PROTOCOLS and INVESTIGATOR-INITIATED TRIALS
Effective October 1, 2008 a new charge model has been implemented on the MUH-CTRC and also applies to protocols that occur at the Hillman CTRC. If you are planning a new study please contact Rosemary Sabol at the Montefiore CTRC to discuss the CTRC charges. A meeting will be scheduled to review the protocol and assist you in developing your budget that will include all CTRC related charges. This meeting is required for any new studies, and should take place at the time the investigator is starting to write the protocol or considering a study that will require the use of the CTRC.

The rates currently applicable to all industry and investigator-initiated industry studies and any other non-federally sponsored clinical trials that utilize the CTRC resources, are determined for each visit.

There is no longer a flat fee for inpatient or outpatient visits that occur on the CTRC. Charges for the visits are based on actual time required for each visit and the CTRC resources required. This will be determined for each visit by the CTRC administration. (For inpatient stays that involve drug infusions where the insurance will be billed for drug administration as standard of care, the patient may be discharged and admitted as an outpatient for billing purposes.)

Ancillary Charges: The UPMC research rates apply to all studies on the MUH-CTRC as of April 1, 2008. In order to secure costs for your study budgets, you should contact Tammy Sutton or Jomica Boyd in the UPMC Patient Business Office, for the institutional account rates. The link for the Institutional Account request form can be found on the IRB web site http://www.irb.pitt.edu/upmcforms/fiscal.htm.

Currently the ancillary charges are billed to the PI on a monthly basis from the MUH-CTRC. However, we hope to implement the process of billing the institutional accounts directly from UPMC. An effective date for this change has not yet been determined. All studies that utilize the MUH-CTRC should have institutional accounts established prior to starting the study.

Nutrition Services: The services provided by the bionutritionist and dietary technician, and the cost of food required for research meals, will be calcuated for each study individually.

The investigator is responsible for all costs associated with the protocol and patients visit. At the present time, UPMC is unable to bill standard of care charges that occur during an inpatient research visit on the MUH-CTRC to the patients insurance. For this reason, all charges should be included in the sponsor budget. If you are currently negotiating a budget with a sponsor and have questions regarding the MUH-CTRC charges please contact our office to schedule a meeting. You may schedule a meeting by contacting Cathy Hensler at 412-648-6691.