FAQ
The Comprehensive Clinical Research Unit (CCRU) was established to provide support and direction to clinician researchers with all aspects of planning for and conducting clinical trials and other types of clinical research within Kaiser Permanente Northern California (KPNC). We employ a highly trained, experienced research staff that provides guidance on research design, project feasibility assessment, budget planning, staff planning, project implementation, biostatistical and data analytic services, and collaborative opportunities.
Which responsibilities have transitioned from KFRI to the CCRU?
Clinical research operations have been transferred to the CCRU. KFRI continues to maintain responsibility for all regulatory affairs and required training. KFRI and the CCRU share responsibility for budget preparation.
Why is this transition happening now?
As clinical research throughout KPNC has been growing, it has become clear there is a need for more centralized operational support for clinical trials and other types of research. In January 2008, clinical trial operational functions were transitioned to the Comprehensive Clinical Research Unit (CCRU) at the Division of Research. The CCRU, under the direction of Alan Go, MD, was formed to increase the support for and coordination of the operational aspects of clinical trials in the KPNC region and to collaborate with KFRI on regulatory compliance issues related to clinical trials.
How will I know if I should contact the CCRU vs. KFRI?
As clinical research operations have been transferred to the CCRU, our aim is to provide direction and support to clinician researchers and research staff throughout the region, as it relates to operational issues. We offer a number of supportive services, with the goal of working collaboratively with research teams to help enhance and expand clinical research operations.
On the other hand, KFRI maintains all responsibility for IRB-related issues, overseeing regulatory and compliance issues, and can assist in the management and preparation of regulatory submissions and the management of regulatory documentation.
For a comparative breakdown of the services provided by the CCRU and KFRI, please see the chart below.
| CURRENT FUNCTION | CCRU | KFRI |
| Clinical Research Design and Methods Education/Training |  |
|
| New Research Study Consultations | |
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| New Trial Protocol and Site Feasibility Assessment | |
|
| Assistance with Protocol Design and Methodology Review | |
|
| Consultation for Personnel Hiring | |
|
| Providing New Clinical Trial Staff Orientation | |
|
| Consultation for Research Staff Management | |
|
| Guidance for Maintaining Essential Research Documents | |
|
| Guidance with Protocol Implementation | |
|
| Assist in preparation and response to audits | |
|
| Research Project Budget Development | |
|
| Assist in Responding to IRB Queries | |
|
| Research Contract Negotiation and Execution | |
|
| IRB Application Preparation, Submission, Resubmission | |
|
| IRB and Sponsor Safety Reporting | |
|
| Clinical Trial Compliance Auditing and Quality Monitoring | |
|
| Internal Audit Report Issuance and Communication | |
|
| Regulatory Oversight of Master Regulatory Files | |
|
| Communicates research training requirements and provides training resources per regulatory and KP requirements | |
|
| Track and documents training status of PI and research teams and reports to the IRB and others | |
|
| Annual KP Employee Required Compliance Training | |
No. KFRI is responsible for all regulatory affairs, including sponsoring and performing internal audits. The CCRU does not perform audits, but can help clinical research teams prepare beforehand for audits initiated by KFRI, the FDA, or the sponsor.
What services does the CCRU provide?
The CCRU provides the following services to KPNC researchers, which can be requested through the Research Collaboration Web Portal (RCWP):
- Research Proposal Review
- Budget Preparation
- Biostatistical/Analytic Support
- Sample size/power calculation
- Retrieval of KPNC data for feasibility analysis or recruitment
- Data extraction and analysis (with appropriate funding)
- Resident research projects
- Community benefit grant application assistance
Through the RCWP, the CCRU also helps outside researchers and sponsors find a potential KPNC collaborator.
Please visit Our Services to view in greater detail the services provided by the CCRU, including the following areas:
