the powers of Andrew....from the SOP

3.5 Research Nurse

The research nurse manages the day-to-day operations of the clinical trial, under the auspices of the

overall PI. The research nurse facilitates the protocol process through a number of activities, such as

verifying that the required tests are completed and that participants have been properly informed and

have signed the appropriate consent form. He or she also assists with eligibility checking, registering

participants, monitoring participants for toxicity, making follow-up appointments with participants, and

teaching other staff members about the protocol. A research nurse may also assist in preparing standard

orders for protocol subject management.

The research nurse is responsible for staff education and participant/family education regarding the

clinical trial. If protocol therapy is delivered by an affiliate or community hospital that has IRB approval to

participate, it is the research nurse who educates and communicates with the health care providers to

ensure protocol compliance.

Although the overall PI is responsible for reporting SAEs to the protocol sponsor and the DFCI IRB, the

research nurse may also be involved with the reporting.