The CTRC nursing staff uniquely combines both clinical and research aspects of patient care. With participant safety a high priority, our experienced CTRC nurses maintain the highest standards of research conduct, utilizing expert clinical judgment, critical thinking skills, and a participant-centered approach. Nursing staff is at the core of the CTRC and their priorities are to ensure that every research study participant feels welcome and appreciated for their investment of time and effort, and that every participant is cared for in a professional and confidential research environment. The nurses are supported by a medical assistant and study coordinator.
CTRC nurses are available to assist investigators with their protocols at various stages of their clinical and translational research, as summarized bellow. Nursing services are provided 24 hours a day, 7 days a week.
Study Preparation
The RN assigned to the specific protocol (“protocol Nurse”) meets with the investigator and study staff to ensure full understanding of the protocol, including regulatory components, and plan for efficient and appropriate implementation of study procedures including:
· review of consent forms;
· data collection forms;
· study flow sheets;
· physician order sheets;
· standardization of procedures, etc.;
· educating CTRC staff about protocol procedures and integrity.
General Research Study Procedures
Nurses are responsible for:
· Instructing participants in specific protocol-related procedures (e.g. self-injection, continuous glucose monitoring device, study medication administration etc) and performing venipuncture for single blood drawings;
· IV placement for serial timed blood drawings (e.g. frequently sampled intravenous glucose tolerance test or oral glucose tolerance test; pharmacokinetic studies etc) and infusions;
· 12-lead EKG tracings;
· Biological specimen collection, processing and short-term storage;
· Data collection and documentation, according to protocol-specific procedures;
· Protocol-specific and general (physiologic and psychological) monitoring of participants throughout the study;
· Administration of investigational medications and monitoring for response, including adverse events;
· Working closely and effectively with investigators/study staff and the Tufts Medical Center-Investigational Drug Service (IDS) to coordinate administration of study medications in a double-masked fashion;
· Coordinating study medications from the Tufts Medical Center-IDS, which are stored in a locked medication room and a medication refrigerator, if required;
· Following rigorous procedures followed for administration of medications in the hospital clinical setting;
· Additional nursing and technical services as needed by specific protocols.