The CTSU provides its services through the work of four major Cores. The Cores include: Ambulatory Clinical Research Nursing, Metabolism and Nutrition, Laboratory and Specimen Processing and Off-Unit Services (Nursing and Study Coordinator).
Other services affiliated with the CTSU include Inpatient Support, The Bone Health Program and Investigational Pharmacy.
Administration and Billing
The Administrative Team at the CTSU (5-7541) can help you with following:
Process new applications
- Coordinate protocol review with all disciplines and sciences
- Provide budgetary support per the Catalyst grant
- Review and approve ancillary requests for individual protocols
- Coordinating and scheduling appointments
- Apply for services via HCCRC Resource Review
Ambulatory Clinical Research Nursing
The CTSU nursing staff provides research subjects with care in the inpatient and outpatient CTSU, the CAT/CR, and at the Waltham location. Research nursing support outside of these discrete locations is supported by the off-unit nursing core.
HOW CAN THE CTSU NURSING STAFF ASSIST ME WITH MY PROTOCOL DEVELOPMENT AND IMPLEMENTATION?
The nurses have a variety of functions with study teams, such as:
They collaborate with study team to develop research data collection tools, case-report forms (CRFs) and teaching tools.
- The nurses develop and edit study order sets to be used when caring for subjects and gathering study data.
- Help create an education plan for CTSU staff to ensure protocol integrity.
- Provide ongoing evaluation and monitoring of protocol progress in collaboration with Principal Investigator, study staff, and CTSU clinical staff.
- Implements protocol education (initial and ongoing); evaluates study participant's understanding to promote study compliance and maintenance.
WHAT KINDS OF SERVICES DO THE NURSES OFFER IN TERMS OF LAB SPECIMEN ACQUISITION AND PROCESSING?
The nurses assist with collecting samples. The samples are then processed by laboratory staff.
WHAT KINDS OF FUNCTIONS DO THE NURSES HAVE RELATED TO STUDY VOLUNTEERS?
The nurses provide the following functions:
They perform nursing assessments for all study volunteers.
- The nurses design a plan of care that ensures subject safety, maintenance of subject's health state, prompt determination of adverse events, protocol integrity and a plan for self-care and follow-up at completion of visit and protocol.
- They monitor subjects' physiological and psychological status throughout the study.
- Administers research medication, observes subject's response using Good Clinical Practice (GCP) standards.
- Active communication with study staff and investigator to evaluate findings and modify plan of care and protocol when necessary.
DXA/pQCT (The Bone Health Program)
The Bone Health Program at Boston Children's Hospital provides comprehensive evaluations of children and adolescents who have or are at risk for low bone density. Two different scans are offered: Dual-energy x-ray absorptiometry (DXA) and Peripheral quantitative computed tomography (pQCT) scans. For more information, contact Kimberley Mitchell, x53789.
Read more about the Bone Health Program.
The Clinical Translational Study Unit on Main 6 East is an 8-bed unit centrally located within the main building of Boston Children's Hospital. The unit is organized to support the management of children participating in clinical research. The CTSU includes a metabolic kitchen and dining room. CTSU nurses are experienced research RN's, CPR certified, proficient with IV insertion and maintenance, and experienced with timely collection and bedside processing of blood, urine, and other research samples.
Pharmacy services are not a core within the CTSU, but can be used in conjunction with studies utilizing any of the other CTSU services.
Please seek consultation with Rocky Anzaldi, R.Ph., Investigational Pharmacist, when designing research studies involving the use of an investigational agent at Ext. 5-2014 or e-mail.
Laboratory and Specimen Processing
Research lab technicians and phlebotomists are available to gather and process samples during the hours of operation at the CTSU. Laboratory services offered through the HCCRC include:
Routine Testing (LabCorp): A centralized laboratory for analysis of routine analytes in real time. The Harvard Catalyst grant is able to support the costs of routine laboratory testing on study protocols based on the annual availability of funds. Results will be available within 24-72 hours. If results are needed sooner than this to allow the research to proceed, the investigator may use their hospital lab for analysis. Support for routine laboratory testing is available only to investigators who use the HCCRC site for inpatient, outpatient or off unit patient visits.
*Please note that tests that need to be billed to insurer can only be sent to the local hospital lab.
Harvard Catalyst Central Lab (HCCL): A centralized CLIA-certified Core Laboratory for batched analysis of research samples. The lab tests run at HCCL will be charged to the investigator on a per sample basis to cover kit and reagent costs. Note that if test results are needed "rush" a surcharge may apply.The HCCL is CLIA-certified and is located at Brigham & Women's Hospital.
Metabolism and Nutrition Research
The Metabolism and Nutrition Research Department provides research diets, nutrition assessment, nutrition education, body composition measurements (including bioelectrical impedance analysis), indirect calorimetry, and dietary intake analysis. The Metabolism and Nutrition Research Department is made up of a Nutrition Research Manager/Registered Dietitian and Dietetic Technicians. As the CTSU Nutrition Research Manager, Nicolle Quinn, MS, RD is able to assist in protocol design, grant writing, and implementation; data analysis; participant clinical care; and food service administration.
SERVICES PROVIDED BY THE CHB CTSU METABOLISM AND NUTRITION RESEARCH DEPARTMENT:
Assistance in writing grant proposals, developing research design, and data analysis
Collection and Analysis of nutrient intake data.
Indirect Calorimetry: A Viasys VMAX 29 indirect calorimetry machine is available for protocol studies
Bioelectrical Impedance: An RJL Quantum II Bioelectrical Body Composition Analyzer is available to measure percent body fat
Designing of House, Therapeutic and Research Diets
Therapeutic Diets: Therapeutic diets (diabetic, renal, HTN, etc) may be incorporated into house and/or research diets.
Controlled Nutrient Diets: Diets are calculated to meet specific nutrient levels defined by the research protocol. Diets can be controlled for macronutrients (carbohydrate, protein, fat) and/or micronutrients (sodium, potassium, magnesium, etc.), glycemic index, or other study specifications.
*Research Diets: We encourage all new investigators to discuss their study requirements with the Nutrition Research Manager to review study design and needs.
Off-Unit Clinical Research Nursing
Off unit research nursing is available to support studies implemented outside the discrete CTSU (former GCRC); inpatient units (outside the CTSU), outpatient settings or in the community. Either alone or in concert with study coordinator(s) off unit research nurses assist investigators with the planning, coordination and implementation of a research study over some portion of time or the life of the study. The following list is not exhaustive but offers examples of services that investigators find helpful:
*A unique concierge-like service or system of guidance to aid investigators in integrating the appropriate research infrastructure available at CHB in the proper sequence while planning for study implementation.
Additional examples (but not an exhaustive list):
Screening patients for eligibility, discussing informed consent with patients/families
Abstracting records from source documents
Specimen procurement and processing
Completing data entry
Maintenance of regulatory binders, updates to the CCI
Working with study staff to prepare for monitoring and audits
Education modules for clinical nursing and other research disciplines
Prepare templates for study orders
Development of source documents/data collection sheets
Identifying and reporting adverse events
Ongoing quality improvement practices
Link investigators to other research support within the institution specific to their research study
Anticipate and resolve clinical dilemmas that can arise with study implementation
Off-Unit Clinical Research Study Coordination
Funded through the Harvard Clinical and Translational Science Center grant, known as Harvard Catalyst, the Clinical Research Coordinator Core is available to support and collaborate with investigators, providing services that include assisting with the organization, implementation and completion of clinical research studies.
Services include, but not limited to:
Recruitment of study participants
Screening of research participants for eligibility
Obtaining informed consent
Scheduling study participants for study visits
Assisting the PI during patient visits
Performs study procedures designated for the study coordinator including collection and delivery of study specimens
Abstracting records from source documents and recording onto Case Report Forms (CRFs)
Completing data entry
Maintenance of regulatory binders, updates to the Committee on Clinical Investigations (CCI)
Assisting the PI in CCI continuing review applications
Working with study staff to prepare for monitoring and audits by an independent monitor or regulatory authorities
New applicants are eligible for an initial 200 hours of Catalyst supported coordinator time. Coordinator support must be used within an approved study timeline before external support for coordinator core services will be required. After the initial 200 hours, an hourly rate will be charged.
Once your study documents have been uploaded onto the HCCRC Resource Request website, and the application is complete, the Coordinator Core support team members will meet with you to discuss your study needs. Based on this meeting a work scope will be developed for your study and your application can move onto the scientific review phase of the Catalyst application process.
Fast-Track Phlebotomy Service
The CTSU is excited to offer phlebotomy services for subjects enrolled in Harvard Catalyst (CTSU) clinical research studies.
Key Benefits: Improved access to CTSU phlebotomy and laboratory services, decreased costs for investigators, rapid turnaround scheduling and collection of research urine specimens. Requests to consolidate the acquisition of clinical labs with research labs will be accepted. *Please note: all clinical labs must be entered into Power Chart and the need for clinical labs must be communicated during the booking process.