RESEARCH CLINICAL OPERATIONS SERVICES

Nurse Practitioners and Physician’s Assistants collaborate with designated physicians and research team members, participate in the informed consent process, and provide education for patients considering enrollment or enrolled in a clinical trial. Mid-level practitioners provide exemplary patient care and work with investigators to define and perform clinical responsibilities in study visits including monitoring toxicities, assessing clinical responses, medical histories and physical exams.

Research-experienced nurses assist study teams with study preparation, implementation and study procedures.

Study preparation and implementation includes meeting with a nurse manager as the protocol's IRB and CCI applications are prepared. Our staff will consult with investigators and protocol team members to ensure accurate and appropriate services are being requested, assist in establishing study worksheets and other collaborations to ensure smooth coordination, implementation and execution.

During protocol execution, nurses provide assessment and monitoring, infusions, IV placement, timed bloods, OGTTs, collaboration with BWH Investigational Drug Service, investigational drug administration, and patient education.

Our nurses ensure participant safety and informed consent, integrity of protocol implementation, and accuracy of data collection and recording. Services are offered in both outpatient and inpatient units, and off-site as well.

Research dietitians provide education, training and mentorship for investigators, students, and colleagues in areas of nutrition research methodology, study design and implementation. Metabolic and nutritional services offered include anthropometry, bioelectrical impedance analysis, calorimetry, nutrient-controlled meal development and preparation, and food record analysis in support of both inpatient and outpatient studies.

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Intensive Physiologic Monitoring (IPM) circadian (sleep) technicians are specifically trained for the high-intensity schedule of events in IPM protocols. Our technicians manage event schedules, utilize data collection systems, monitor and documents IPM participants throughout wake and sleep periods, collect, measure, and aliquot samples, and administer and monitor IPM participant completion of written assessments.

Laboratory technicians are experienced with many research techniques and activities and support visits by providing phlebotomy, automated BP/HR/O2 Sat/RR/ECG, specimen collection, and specimen basic processing services. All our technicians are International Air Transport Association (IATA) certified to ship biological specimens both domestically and internationally using any courier (e.g., Fed Ex, UPS). Lab techs are also experienced in working with many pharmaceutical companies and commercial testing labs.

Phlebotomy Training: Training for study staff who draw blood for clinical research studies and consists of three parts: a lecture on phlebotomy procedures, an observed phlebotomy on a simulation device and practice venipuncture on a simulation device.

EKG/Vital Signs Course: Introduce the concepts of vital sign monitoring, anatomical landmarks, fundamental physiology of vital signs, EKG lead placements and safety guidelines. Vital signs included are temperature, pulse, respiration rate and blood pressure. Underlying the demonstrations of taking vital signs and performing EKGs will be the concepts of standard precautions, patient identification, interpersonal communication and accurate documentation.

CCI staff facilitates coordination with IDS for pharmaceutical services and guidance in support of all research groups and investigators. IDS ensures delivery of high quality pharmaceutical care, adhering to all laws and regulations while minimizing the risks associated with participation in an investigational drug trial. Services include drug handling and control, compliance with FDA, state, and hospital requirements, assistance in proper and accurate record keeping, establish randomization procedures and schemes, providing drug information and education, preparing sterile and non-sterile compounding, minimizing problems with the availability, preparation, and storage of study drugs, and promoting and assuring patient safety. Investigational drugs and study-related information are accessible 24 hours a day, 7 days a week.