General Policies
Criteria for using CRS core services
Research studies using CRS services must meet the following criteria:
- The proposed study is determined to have scientific merit by the CRS Scientific Advisory Committee, National Institutes of Health, or through an alternative review process sanctioned by the CRS Scientific Advisory Committee. Specifically, reviewers believe the proposed study will contribute to research knowledge OR the study will generate preliminary data that will be used to support a request for funding support within one year of the completion of the preliminary study.
- Requested services can be safely provided in accordance with regulatory and sponsor guidelines as determined through review/approval by the appropriate CRS core service managers.
- For studies that receive CRS funding 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 by the CRS Scientific Advisory.
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.
