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. However, you will need to have a separate onboarding meeting for 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.
How do I get approval for use of the CRS?
Once you have informed your OCTA team that CRS services will be included for your study, you can proceed to the next step. NOTE: If your study does not require OCTA services for budgeting, please complete the CTSI Study Onboarding and Inquiry Request Form.
Where can I access the CRS onboarding form?
Here is a link to the CTSI Study Onboarding and Inquiry Request Form. Please review all the steps in the Guidelines and Application Process section before completing this form.
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 the study teamwill need to new complete another CTSI Study Onboarding and Inquiry Request Form.
How are research participants scheduled?
The protocol in-service meeting is the first step before scheduling visits. After this meeting, the CRS clinic will provide information regarding the scheduling process. The research team needs to contact the CRS prior to making arrangements with the research participant. After receiving the request, CRS nursing will review availability. Scheduling depends on the availability of beds, staffing, and equipment.
Who obtains informed consent of the research participant?
It is the responsibility of the principal investigator or appropriate designated person 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. Investigators who need skilled nursing or other support are encouraged to contact the CRS Nurse Manager for your site to review your study needs. You may submit a CTSI inquiry form for next steps or contact CRS Protocol Services for additional guidance.
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.