Clinical Research Center Industry Guidelines for Conducting Research
- In accordance with the Guidelines of the CTSI/Clinical Research Center’s Program (National Center for Research Centers, NIH), the Clinical Research Center (CRC) is obligated to recover the cost of conducting research that is initiated between industry/pharmaceutical development and manufacturing companies, and UCSF.
- The cost recovery requirement applies regardless of the scientific or clinical significance or outcome of the research.
- All industry research is subject to the same regulatory guidelines and requirements (CHR and other pertinent approval processes) and scientific standards set by the CRC/CTSI Advisory Committees and NIH.
- The CRC Application Review and Set-Up/Implementation charge must be paid in full regardless of whether participants are ever enrolled in a protocol. The fee includes expenses common to all protocols such as the CRC management team’s time in reviewing the application, and additional administrative time to record protocol activity, account for use of CRC resources and preparation of journal transfers.
- Once the study has received CRC Advisory Committee approval, the Set-Up/Implementation charge is to be paid in full.
- Ongoing CRC costs, per approved protocol budgets are to be reimbursed on a per outpatient visit and/or Inpatient admission and will be billed on a monthly basis.
- For partially or fully supported Industry clinical research that has been initiated by a faculty investigator, and with adequate documentation that the research originated with the investigator, the CRC may provide resources to complement those provided by the industry sponsor.
- To ensure each research study is accurately priced, please contact the appropriate CRC Administrative Director per site/s to cost out a study. Investigators are advised to allow for dropouts in their budgeting process. Administrative contacts for the CRC sites are as follows:
Moffitt Adult / Mount Zion Phase 1 Unit
Cathleen Tierney, Administrative DirectorMoffitt Pediatrics / NCRC
Mario Moreno, Administrative DirectorSan Francisco General Hospital
Debra Greenblat, Administrative DirectorVAMC
Pierre Crouch, RN, MSN, NP, Nurse ManagerCHORI
Laurie Schumacher, MPH, PhD
Related Documents:
- Industry Guidelines Agreement Form (PDF 117KM)
- Industry Rates (PDF 127KM)
