Services and Infrastructure Questions
- What is Clinical Research Services (CRS)?
Clinical Research Services (CRS) integrates five clinical research sites across San Francisco that provide an array of adult and pediatric services and translate promising clinical research ideas into successful protocols. The CRS offers an array of services, including clinical research nursing and sample processing.
- Who can use the CRS?
The CRS is available to UCSF faculty members in the Schools of Medicine, Nursing, Dentistry, and Pharmacy. Investigators at the VA Medical Center in San Francisco may use the CRS services as well.
- What kind of research can be done utilizing CRS?
The CRS supports human-based translational research. Studies may involve either healthy volunteers or patients with specific diagnoses. We facilitate research in a broad area of medical disciplines including general internal medicine, internal medicine subspecialties, radiology, surgery, epidemiology, obstetrics, psychiatry, pediatrics and nursing.
Policies and Scheduling Questions
- Can I conduct my research protocol at more than one CRS site?
Yes. There will be one review by the Advisory Committee. However, you will need to meet with the staff at each of the sites where you want to conduct your project.
- Are non-MDs allowed to conduct studies in the CRS units?
Yes. However all non-MD investigators such as PharmDs and PhDs must have an MD or Nurse Practitioner collaborator who will assume medical responsibility for the research participants.
- Can projects be submitted to the CRS Advisory Committee prior to IRB approval?
Yes. The Advisory Committee will accept projects for review prior to or concurrent with the IRB approval process.
- How do I get approval for use of the CRS?
Once you have completed the Office of Clinical Trial Activation (OCTA) intake form and notified OCTA that CRS services will be utilized for your study, an IRB Application (and approval if already obtained from IRB) should be submitted to the CRS Protocol Manager, who will coordinate the review by the CRS Advisory Committee. The investigative team works with the Protocol Manager during this process.
- Where can I get the CRS application forms?
The application forms are available online in the Guidelines and Application Process section.
- What if I have a project that needs to start recruitment before the Advisory Committee approval?
If you have IRB approval, you may request administrative approval to start the project prior to full review by the Advisory Committee. This would only be considered if you would miss a rare research opportunity.
- What if there are revisions to the original, approved protocol or consent?
All protocol modifications and renewals must be submitted to the IRB and copied to the CRS for review. If a protocol undergoes a major modification that includes changes to the CRS resource utilization, a second presentation to the Advisory Committee may be required.
- How are research participants scheduled?
The research team contacts the CRS prior to making arrangements with the research participant to insure that space is available. Scheduling depends on the availability of beds, staffing, and equipment. Site-specific instructions will be provided during the protocol in-service.
- Who obtains informed consent of the research participant?
It is the responsibility of the principal investigator or appropriate designate to obtain informed consent from the research participant prior to the commencement of a study.
- How is medical care provided on the CRS units?
The physician investigator is responsible for the medical care of research participants. Arrangements for emergency care must be formalized before study implementation.
Budgeting Questions
- Can I conduct an industry-sponsored project on the CRS?
Yes. Industry pays for the use of the CRS facilities and staff. Investigators who need skilled nursing or other support are encouraged to contact the CRS Administrator to inquire about the costs and support available. A budget that covers all the costs of the entire research proposal utilizing CRS resources (nursing, sample processing, exercise physiology) must be approved by the Investigator and sponsor company prior to final approval.
- What is the pricing for new protocols?
- Do you have funds for ancillary testing?
The CRS does not have funds to cover ancillary testing performed in departments such as the clinical laboratory testing or radiology.
- Do I need my own funding to use the CRS?
Yes, investigators are expected to contribute to the costs of using CRS services.
If you have additional questions, submit an inquiry form and a budget analyst will contact you regarding your next steps.
