Regulatory Affairs
Though the responsibility for clinical research operations has been transitioned to the Comprehensive Clinical Research Unit (CCRU), the Kaiser Foundation Research Institute (KFRI) continues to be responsible for all internal regulatory, research compliance, and quality monitoring The CCRU works closely with the KFRI regulatory team to offer researchers support throughout the complex regulatory process.
KFRI employs a highly trained and skilled regulatory compliance team, accomplished in the management and preparation of regulatory submissions. The regulatory compliance services offered to clinical trial teams includes the management of regulatory documentation in audit-ready condition in accordance with FDA regulations, the Guideline for Good Clinical Practice and KP policies and procedures. Regulatory compliance support helps ensure rigorous quality control of submissions, as well as continuing maintenance of regulatory documents and IRB applications.
At the CCRU, we provide support with multifaceted clinical trials and help support integrated planning and implementation for Phase II-IV clinical trials. The CCRU can provide the following services to support clinical trial teams during the regulatory affairs process:
- Advice and assistance in preparing for internal and external audits
- Support in responding to and resolving Institutional Review Board concerns regarding study proposals
Transition Process
For clarification regarding the current responsibilities of KFRI and the CCRU, please see the table below or the FAQ section of this website. Please Contact Us if you have any further questions.
| CURRENT FUNCTION | CCRU | KFRI |
| Clinical Research Design and Methods Education/Training |  |
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| New Research Study Consultations | |
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| New Trial Protocol and Site Feasibility Assessment | |
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| Assistance with Protocol Design and Methodology Review | |
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| Consultation for Personnel Hiring | |
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| Providing New Clinical Trial Staff Orientation | |
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| Consultation for Research Staff Management | |
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| Guidance for Maintaining Essential Research Documents | |
|
| Guidance with Protocol Implementation | |
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| Assist in preparation and response to audits | |
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| Research Project Budget Development | |
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| Assist in Responding to IRB Queries | |
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| Research Contract Negotiation and Execution | |
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| IRB Application Preparation, Submission, Resubmission | |
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| IRB and Sponsor Safety Reporting | |
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| Clinical Trial Compliance Auditing and Quality Monitoring | |
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| Internal Audit Report Issuance and Communication | |
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| Regulatory Oversight of Master Regulatory Files | |
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| Communicates research training requirements and provides training resources per regulatory and KP requirements | |
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| Track and documents training status of PI and research teams and reports to the IRB and others | |
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| Annual KP Employee Required Compliance Training | |
Suggested Links
- KFRI Policies & Guidance Overview (Programwide)
- Division of Research (DOR)
- KPNC Institutional Review Board (IRB)
- Clintrials.gov
