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
New Research Study Consultations
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

Suggested Links

1. KFRI Policies and Guidance Overview (Programwide)
2. Division of Research (DOR) 
3. KPNC Institutional Review Board (IRB) 
4. clinicaltrials.gov

Federal Regulations

1. The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
2. Office of Human Research Protections (OHRP)
3. International Commission on Harmonization (ICH)