Clinical Research Services Industry Guidelines for Conducting Research
- In accordance with the Guidelines of the CTSI/Clinical Research Services Program (National Center for Research Centers, NIH), Clinical Research Services (CRS) 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 CTSI/CRS Advisory Committees and NIH.
- The CRS 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 CRS management team’s time in reviewing the application, and additional administrative time to record protocol activity, account for use of CRS resources and preparation of journal transfers.
- Once the study has received CRS Advisory Committee approval, the Set-Up/Implementation charge is to be paid in full.
- Ongoing CRS 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 CRS may provide resources to complement those provided by the industry sponsor.
- To ensure your research study is accurately priced, please contact the appropriate CRS costing representative for the CRS site at which your research will be conducted. Investigators are advised to allow for dropouts in their budgeting process. Administrative contacts for the CRS sites are as follows:
Moffitt-Adult, Moffitt-Pediatrics, Mount Zion Phase 1 Unit, San Francisco General Hospital, and Moffitt-Neonatal
Pierre Crouch, RN, MSN, NP, Nurse Manager
Laurie Schumacher, MPH, PhD