Investigator Manual
VI.
Nursing Assistance
Role of the Study Coordinator: After a protocol has received CCI
approval, a CRC nurse will be assigned to the study as Study Coordinator. In the role of Study
Coordinator, the nurse works with the investigator to facilitate the
implementation and proper conduct of the study. The nurse functions as a
liaison between the CRC nursing staff and the investigator’s team.
Meetings with the investigator are essential in
order to facilitate the role of the study coordinator and assure timely
implementation of the study. Patients cannot be scheduled for a study visit in the
CRC until the Study Coordinator has determined that everything has been
completed.
Specific nursing responsibilities regarding the
care of the patient, the conduct of the protocol, and the testing procedures
need to be identified. These are then delineated in a nursing protocol for the
study. This protocol includes a review of the purpose of the study, nursing
preparation and responsibilities for testing, data collections, flow sheets, and
any specific guidelines for patient safety. The nurse works with the
investigator to review the plan to ensure consistent and effective management of
patient care and accurate data collection.
The Study Coordinator will assist the investigator
in identifying what equipment and supplies the CRC can provide and what the
investigator must supply. It is the investigator’s responsibility to obtain any
special equipment or supplies not available on the CRC.
The nurse also will assist the investigator in the
preparation of standard orders. It is strongly recommended that, whenever
possible, investigators utilize standard orders for patients enrolled in a
study.
The investigator may be asked to hold an
in-service meeting on the CRC to explain the protocol in detail to the
available nursing staff. This presentation will be videotaped so that all CRC
nurses may become familiar with the study. The Study Coordinator is the
facilitator of the study to the nursing unit, but because of rotating nursing
schedules, a variety of CRC staff will participate in the execution of the
protocol.
The investigator must provide the Study Coordinator
with the most current approved consent form. It is also the investigator’s
responsibility to communicate any modifications in the protocol to the study
coordinator so the changes can be made in the nursing protocol. All the
appropriate CCI documentation authorizing the changes must be provided to the
coordinator before any change in the protocol will be carried out.
For more information about this process, please contact Linda Godfrey-Bailey, MSN, APRN, BC, Nurse Manager (667-3354).
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