The Clinical Research and Trials Unit (CRTU) provides experienced research administration, implementation, and coordination of clinical trials conducted in the Kaiser Permanente Northwest (KPNW) care delivery system and at the CHR Research Clinic. The department works with Northwest Permanente physicians and CHR investigators, ensuring patient safety, compliance with research regulations, and data integrity.
The Center for Health Research has been supporting the conduct of clinical trials since 1972. The program initially focused on oncology and hematology studies conducted in the outpatient arena. Over time, clinical trial demand has expanded into many other disease areas with funding from both federal and industry sponsors with a focus on Phase 2 and 3 drug clinical trials and Class II and III device trials.
CRTU has also supported KPNW clinical care providers with:
- Drug and device expanded access use requests (both single patient and expanded access treatment programs), and
- Humanitarian Use Device (HUD) requests
Department Staff
The CRTU research staff have an average of 15 years of clinical trial experience, with several holding certification as Certified Clinical Research Professionals through the Society of Clinical Research Professionals (SOCRA) or through the Association of Clinical Research Professionals (ACRP). Staff roles include:
- Study Coordinators
- Project Managers
- Research Nurses
- Recruitment Specialists
- Data Managers
- Regulatory and Compliance Staff
The department provides a full range of clinical trial services, including trial management, recruitment, clinical interventions, data entry, and telephone and in-person follow-up. In addition, clinic staff screen for study eligibility by reviewing patients’ medical records, communicating with patients’ primary and specialty care providers, ordering research drugs dispensed though KP pharmacies, and collecting biological specimens for studies.
Research Clinics
The Center for Health Research has two on-site clinics, allowing staff to meet with and interview participants, collect specimens, and perform measurements required by research protocols.
The clinic on the Interstate campus includes a reception and waiting area, lab, pharmacy space, and several private rooms for interviews, physical exams, blood pressure monitoring, and general data collection. The pharmacy space includes secure drug storage and medication refrigerators and freezers. The clinic laboratory is fully equipped so that staff can perform study-specific phlebotomy, processing, long- and short-term specimen storage in -70 or -20 freezers, and CLIA-waived laboratory testing.
The clinic on the Sunnyside campus offers a participant interview and specimen collection area and lab space, including equipment for CLIA-waived laboratory testing, processing, and long- and short-term storage in -70 or -20 freezers. The Sunnyside clinic is embedded near outpatient and inpatient clinical settings, making it a convenient location for research participants to combine research opportunities with their routine clinical care. Research staff recruit potential participants in both inpatient and outpatient settings and collaborate closely with KPNW care teams.