Research Resources
Pediatric Clinical Unit at Children's Hospital Regional Medical Center
The
PCRC located on the 6th floor of Children's newly
constructed Ambulatory Care Building (ACB). It operates as the pediatric clinical research center affiliated
with the UW School of Medicine's Institute of Translational Health Sciences, and provides specialty nursing
expertise, dedicated research exam rooms, specimen processing and extensive supporting services for
researchers working with pediatric research participants. About 140 research studies - involving more than
30 hospital divisions, such as Infectious Disease, Endocrinology, and Nephrology - are underway at the PCRC. Additionally, PCRC nurses travel throughout the hospital to support research activities occurring in inpatient and surgical areas. The facility enables the study of unusual diseases or unique opportunities to study commonly encountered clinical disorders under conditions or supervision, which could not be readily obtained in primary clinical care facilities.
Medical Director: Margaret Rosenfeld, MD, MPH
Interim Nurse Manager: Pam Joy, RN
Administrative Manager: Gloria Venegas
The PCRC facilitates patient-oriented investigations by providing:
- Dedicated clinical-research outpatient space
- Nursing staff trained in Good Clinical Practice (GCP) and expert in implementing research protocols
- Patient assessment and ability to perform questionnaires
- Specimen collection and processing
- A variety of procedures listed in more detail below.
- Assistance with research study documents under GCP compliance
- Source documents
- CRF's
- Study orders
- Research checklist (eligibility checklists, research procedure checklists)
- Development of orders for all your protocols
- A primary nurse specifically assigned to your protocol to function as a member of your clinical research team
- Selected routine laboratory tests
- Routine supplies are included in cost rates
- Short term storage of specimens in our laboratory
- Conference room use for research meetings and research projects
- Assistance in developing appropriate safety plans for your studies
Facilities
The PCRC is located on the 6th floor of the newly constructed Ambulatory Care Building (ACB). The unit occupies 4,643 sq. ft. of which 3,856 sq. ft. is dedicated to patient and clinical space.
The patient care area includes the following:
- 406-sq.-ft. Lab for simple processing and storage of specimens and Soiled Utility
- Ten dedicated outpatient exam rooms
- Blood Draw Room
- Patient procedure/sleep study room
- Nourishment Room
- Medication and clean utility rooms
- Computer workstations for study team use
- Patient interview room with video taping equipment
- Conference room
- Outpatient and Inpatient Care
We provide both outpatient services and inpatient services if needed. We can also bring our services to where you do your research. For example, if your research takes place on an inpatient service such as the Intensive Care Unit or the Bone Marrow Transplant Unit, the PCRC staff can still assist you in conducting research. We go to all inpatient and outpatient areas in the hospital. Furthermore, if your outpatient research takes place in the Emergency Room, community or other location we can still be of service. If you have an unusual site of practice or unusual research need, please call the PCRC Nurse Manager PRIOR to submitting an application.
Nursing Expertise
Our nurses are clinical research nurses who are trained in Good Clinical Practices and pay attention to detail. A primary nurse will be assigned to work on your study. The primary nurse develops a protocol notebook that serves as a standard reference and guide for implementing your study. The notebook includes a synopsis of the study, copy of the protocol, IRB/SAC application, research flow sheets source, document forms, physician's orders, etc. It details the specific standardized procedures required for implementing your study. The primary nurse becomes a member of your research team. We make every attempt to assign you the same primary nurse for your protocols so that person can develop some level of expertise in your research area.
Procedures
Many investigators require special procedures be performed on subjects that are enrolled on studies. The PCRC nursing staff is trained to perform the following procedures:
- Non-invasive blood pressure and vital sign monitoring
- Placement of peripheral venous access devices
- Frequent blood sampling via angiocaths and arterial lines
- Pulse oximetry
- Spirometry and assistance with infant pulmonary function testing
- Glucose monitoring
- Specimen preparation and processing, aliquoting to specific protocol specifications and short term storage
- Administration of questionnaires
- ECGs with automated readings
- Continuous cardiac monitoring
- Maintenance and care of peripheral, central and arterial lines
- Administration of blood and blood products
- Portacath access
- Administration of investigational drugs
- Patient assessments
- Height, weight and anthropometric measurements
- Pain assessments and pain management via Patient Controlled Analgesics
- Allergy skin testing
Annual competency based training insures proficiency in these test procedures. If you plan a study that requires a special procedure that is not similar to ones listed here, please contact the Nurse Manager PRIOR to submission of your application to discuss feasibility of the approach and potential nursing training.
Subject Safety
Patient safety is of utmost importance to the PCRC program. All studies conducted must have Children's Institutional Board Review (IRB) review and Scientific Advisory Committee (SAC) approval. All patients and/or parents/guardians must have signed an informed assent/consent, which assures that they understand the risk, benefits and all procedures conducted on the unit, and that their personal rights are protected. In addition, all patients and/or their parents/guardian must sign a HIPAA authorization form. The Research Subject Advocate (RSA) Program associated with the GCRC and PCRC will help you develop safety monitoring plans for your studies, craft informed consents, and help you make an estimate of study risk. There are several other services available to you via the RSA program.
Learn more about Federal Guidelines for Clinical Research and Good Clinical Practice
Education
Education of investigators and their staff in proper conduct of clinical research and protection of human subjects is a priority of the unit. Click here to learn more about educational opportunities for junior investigators, clinical research staff and residents.