General Policies
Criteria for using CRS core services
Research studies using CRS services must meet the following criteria:
Effective January 1, 2025, Clinical Research Services updated department guidelines regarding the scientific review process.
All studies conducted using the CRS units and services will need to have undergone scientific review. This scientific review requirement can be fulfilled by a review from an external national or state organizations such as the US Department of Health and Human Services agencies (NIH, FDA, CDC, ARHQ). For studies that have been reviewed by the FDA. the sponsor will need to provide confirmation of the FDA's review with an OK to Proceed letter or memo verifying the FDA's review for the study's associated IND.
Additional organizations include: National Science Foundation (NSF), U.S. Department of Defense (DOD), U.S. Environmental Protection Agency (EPA), Veterans Administration (VA), California Institute for Regenerative Medicine (CIRM)
- If a study has undergone a scientific review by a state- or national-level organization not on this list, the review can be submitted to CRS to determine if it meets the requirements for external scientific review. At a minimum, the review needs to assess the rationale, study design, and statistical analysis plan of the study.
- For studies that receive CRS funded support (generally all studies except those fully funded by industry sponsors), the investigator will (i) to acknowledge the role of the CTSI in all future publications resulting from the research; and (ii) to provide to CRS a list of all publications, further external funding, and intellectual property arising from CRS-supported research.
- Investigators must provide full documentation regarding funding for investigator-initiated proposals partially supported by industry (see additional information below).
Review process
- All protocols requesting the use of CRS services will be reviewed for feasibility and utilization of CRS resources by CRS leadership.
- All industry funded protocols and investigator-initiated studies requesting the use of CRS resources will be evaluated for scientific merit.
Prioritization to receive CRS resources will depend on assessment of scientific merit and the resource support required.
Industry-Sponsored Studies
Industry-initiated Research
Industry-initiated studies will be charged industry rates and do not qualify for CRS funding support. In instances where UCSF investigators have collaborated to design a study that is sponsored by an industry partner, and the industry partner will own the data, industry rates will be charged, and CRS funding support will not be provided.
Investigator-initiated, Industry-involved Research (wherein sponsor provides drug/device and/or funding)
Assignment of CRS rates will depend on the proportion of funding from the sponsor as well as the contract language in the Clinical Trial Agreement. Investigators must provide CRS with a copy of:
- All relevant correspondence documenting the investigator and sponsor roles in initiating the study and creating the protocol, and
- The industry master contract that indicates who owns the drug or device, who owns the study data and intellectual property, and a line-item budget detailing the sponsor's financial support.
Scientific Review Only
For studies referred by IRB for scientific review, please contact [email protected] for information.