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 one of the CRS Scientific Advisory Committees 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 other than those that are fully funded by industry sponsors, the investigator provides assurance (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 that utilize CRS resources must undergo review by the CRS Scientific Advisory Committee and will be evaluated for:
- Scientific merit
- Utilization of CRS resources
Recommendations for deployment of CRS resources for each protocol will be made by the CRS Scientific Advisory Committee; prioritization to receive resources will depend on the Committee’s assessment of scientific merit and the quantity of resource support required. The Committee reserves the right to adjust support at any time during a study depending on overall availability of CRS funds.
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 that will own the data, industry rates will be charged and CRS funding will likewise 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’s and sponsor’s 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.
Investigator-Initiated, Unfunded Research
- Funding should be sought through institutional, departmental, and/or divisional programs, including the RAP programs, and other institutional support opportunities. CRS resources, if and when available, may only be contributed to assist (i) early career investigators whose projects are judged to have a high likelihood of providing pilot data for outside funding or (ii) investigators whose protocols are judged to have exceptional scientific merit by the CRS Scientific Advisory Committee.
Scientific Review Only
For studies referred by IRB for scientific review, please contact [email protected] for information.
