Seattle Children’s Pediatric Clinical Research Center

child healthcareThe Seattle Children's Research Institute (SCRI) - Center for Clinical Translational Research (CCTR) - Pediatric Clinical Research Center (PCRC) is a core resource within the Institute of Translational Health Sciences (ITHS) Clinical Research Center Network. Established in 1996, this multidisciplinary facility provides an environment and resources for the conduct of clinical research in children less than 21 years of age. The facility enables the study of a broad spectrum of human pathophysiology and diseases as well as commonly encountered clinical disorders.

Facilities

 The PCRC is located on the 6th floor of the Ambulatory Care Building (ACB) at Seattle Children's Hospital. The unit occupies 4,643 sq. ft. and includes:

  • Lab for simple processing and storage of specimens
  • 8 dedicated outpatient exam rooms
  • 1 Sleep Study room w/video taping equipment
  • 1 Psychological and neuropsychological testing Room, w/video taping equipment
  • Weights/Measurements and Blood Draw Room
  • Nourishment Room
  • Secured Medication Room
  • Secured areas for storage of study supplies
  • Drop in Computer workstations for study teams
  • Patient consenting/interview room
  • Conference room

In addition to providing outpatient services, PCRC nurses can conduct research activities in other hospital areas such as the inpatient units, ER, OR, and ambulatory clinics. If you have an unusual site of practice or research need, please call the PCRC Nurse Manager prior to submitting an application.

Nursing expertise

PCRC research nurses are trained in Good Clinical Practice for Research and are PALS-certified. A primary nurse is assigned each study. The role of the primary nurse is to serves as the main point of contact for a study. The primary nurse also develops the CRC protocol notebook (the standard reference guide for implementing your study in the PCRC) and conducts the protocol implementation meeting (PIM). The PCRC makes every effort to assign the same primary nurse for all your protocols so that person can develop some level of expertise in your research area.

Procedures

The PCRC nurses are trained to perform the following procedures:

  • Allergy skin testing
  • Assistance with infant pulmonary function testing
  • Anthropometrics/Body measurements
  • Central venous catheter access
  • ECG’s
  • Glucose tolerance testing
  • Infusion of investigational agents
  • Intensive/Complex PK-PD
  • Lab specimen processing and short term storage
  • Medication distribution
  • Pain assessments
  • Patient monitoring
  • PK studies
  • Plasma/Serum Storage
  • PO, SQ, Topical, or IM medication administration
  • Questionnaire administration, interviews, and surveys
  • Single blood draws
  • Spirometry
  • Subject education
  • Urine collection, storage
  • Urine pregnancy testing
  • Vital sings including oximetry

If you have any questions about the procedures the PCRC nurses are able to perform, please contact the Nurse Administrator, Pam Joy.

Equipment and supplies

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  • Two -80 C freezers & -20 freezer and refrigerator for specimens
  • BIA Analyzer System Quantum X
  • Biodynamics-Body composition analyzer
  • Blanket warmers
  • Centrifuges: refrigerated and room temperature
  • Microcentrifuges: refrigerated and room temperature
  • Digital scales (infant and adult)
  • Dry and wet ice
  • EKG machine: MAC 500012 lead
  • Glucose monitoring (Roche AccuChek)
  • Grason-Stadler Auto Tymp for tympanomometry
  • Hydraulic Hand Dynamometer
  • Infusion pumps
  • Length Board
  • Medication refrigerator
  • Hospital beds ordered from central supply for sleep room
  • Oxygen and suction in each room
  • Oxygen, free standing mobile tank
  • Oximeter
  • Projector and Projector Screen
  • Psychological and neuropsychological Psychometry Supplies:
  • Bayley Scales-III
  • Beery VMI
  • DAS-II
  • D-KEFS
  • Mullen Scales
  • NEPSY
  • WASI
  • WIAT-II
  • WISC-IV
  • WRAML
  • In-floor scale (calibrated quarterly)
  • Spirometer
  • Stadiometer (calibrated weekly)
  • TV/VCR/DVD in each exam room
  • 4 Cameras/Video equipment, Mixer Splitter, DVD/VHS Recorder/Player, microphone
  • Welch Allyn Vital Sign Monitors in each exam room

Subject Safety

Patient safety is of utmost importance. All studies must have Institutional Board Review (IRB) approval and may require Scientific Review Committee (SRC) approval. All patients and/or parents/guardians must sign an informed consent and/or assent, which assures that they understand the risks, benefits, and procedures conducted as part of the study. In addition, all patients and/or their parents/guardian must sign a Seattle Children's HIPAA authorization form.

 

How researchers use this resource or service

The PCRC is available to investigators with Seattle Children’s IRB approved studies. If an investigator is not a credentialed Seattle Children’s provider, they will need to be credentialed or collaborate with a credentialed investigator. The unit adheres to the federal guidelines assuring equal representation of all ethnic and gender groups. Education of health care providers, investigators and research staff in the proper conduct of clinical research and protection of human subjects is a priority of the unit. Any investigator or research team member utilizing the PCRC facilities is expected to follow the federal guidelines on protection of human subject’s protections and Good Clinical Practice (GCP) Guidelines. It is the responsibility of the GCRC Medical Director and staff to assure that all investigators conduct of studies is appropriate. If you have any questions about whether your study is right for the PCRC please contact Margaret Rosenfeld, MD, PCRC Medical Director.

The PCRC has 121 open and active studies from a broad range of departments/specialties including: Anesthesiology, Adolescent Medicine, Cardiology, Craniofacial, Critical/intensive Care, Emergency, Endocrinology, Gastroenterology, General Pediatrics, Genetics & Developmental Medicine, Hematology/oncology, Infectious Disease/immunology/Rheumatology, Nephrology, Pulmonary, Psychiatry and Behavioral Sciences, Rehabilitation Medicine/Occupational Therapy/Prosthetics and Orthotics, General Surgery, Biobehavioral Nursing and Health Systems, Human Health and Community Medicine-Epidemiology, Social Work.

 

Other services of interest

ITHS and the CCTR have numerous clinical research resource cores. Please contact the individuals below for additional information or assistance.

  • Nutrition Core – Dietary Consultation
    Susan Casey, Clinical Dietitian II
    Susan.casey@seattlechildrens.org –
    (206) 987-1744
  • Scientific Review Committee – PCRC Application Process Assistance
    Contact Alicia Stone-Zipse, Admin./Program Assistant
  • Biomedical Statistics - Assistance in trial or study design as well as data analysis
    Contact Kristy Seidel, Biostatistical Services
  • Biomedical Informatics - Database design and clinical research tools
    Contact Paul Oldenkamp, System Analyst Programmer
  • Regulatory Support and Bioethics Core – Data Safety Monitory Plan assistance and medical monitoring
    Contact Ann Melvin, MD
  • Research Specimen Processing Lab Core (RSPL) - The RSPL provides assistance and support for the processing, packaging, storage, and shipment of research specimens for clinical research studies.
    Courtney Dethlefs
    Courtney.dethlefs@seattlechildrens.org -
    (206) 884-7863
  • Research Staff Support Core –The staff support core provides investigators with clinical research staff that assist them with the organization, implementation and completion of clinical research studies.
    Contact Pam Joy, RN, MN, PNP
  • Psychological and Neuropsychological Testing Core – Psychometrists Core and Psychologist Consultation
    David Breiger, PhD, Clinical Associate Professor
    David.breiger@seattlechildrens.org –
    (206) 987-2164

Fees

The PCRC operates as a "fee for service" core. Investigators planning to use the PCRC must work with the Office of Sponsored Research (OSR) budget analysts to plan a budget for any contract or grant submission.

Contracts or grants submitted on or after February 5, 2008 must have a PCRC budget associated with the proposal to have access to PCRC facilities. The PCRC rates are based on a “per visit” charge based upon the level of complexity of each visit from Level 1 to Level 5. For protocol review and budget implementation,  contact OSR Clinical Research Budget Analysts: Michelle Palmer or Sandy Johnson.

In general, costs of hospital-provided research patient care services are based on the annual "research patient care rate agreement" negotiated with the HHS Division of Cost Allocation. Charges for PCRC services are developed using a cost center model and are based on the actual cost of services with possible subsidies based on membership status with the ITHS and the CCTR.

Utilization of the PCRC requires start-up fees that cover the cost of:

  • review of protocol feasibility and scientific merit review
  • the Protocol Implementation Meeting (PIM)
  • regulatory document maintenance
  • scheduling, and orientation to the PCRC
  • education
  • compliance.

The start-up fees are also subject to subsidies based on the principal investigator’s membership status with the ITHS and/or the CCTR. The PCRC’s fees are also based on the type or category of the study. Subsidies associated with each study category are described on the "CCTR Subsidies for PCRC Services and Setup Rates". Current fees for each visit may be obtained from the OSR Clinical Research Budget Analysts.

Getting started

Read getting started at the Seattle Children's PCRC. If you have any questions, send email to Nurse Administrator, Pam Joy.

Last modified: May 11, 2009