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/hematology studies conducted in the outpatient arena. Over time, clinical trial demand has expanded into many other disease areas with funding from both NIH and industry sponsors with a focus on Phase 2 and 3 investigational device and drug clinical trials.
The CRTU research staff have an average of 15 years of clinical trial experience. Most have received 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
- Recruitment Specialists
- Clinical Trial Research Assistants
- Data Managers
- Regulatory Coordinators
The department provides a full range of clinical trial services, including but not limited to trial management, recruitment, clinical measures, data entry, telephone, and in-person follow-up. Clinic staff also conduct off-site participant study assessments at community research locations and at participants’ homes. In addition, clinic staff can screen for study eligibility by reviewing patients’ medical records, communicate with patient’s primary care providers, order research drugs dispensed though KP pharmacies, and collect biological specimens for studies.
The Center for Health Research – Northwest has an on-site clinic to collect specimens and perform measurements required by research protocols. The clinic includes a reception and waiting area, lab, pharmacy space, and 15 private rooms for interviews, physical exams, blood pressure monitoring, spirometry, abdominal ultrasound, bone density measurement by DXA, and general data collection. The pharmacy space includes secure drug storage and a medication refrigerator and freezer. 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.