It is the responsibility of the investigator to work with the staff of the GCRC to ensure that the research protocol evolves into a functional research study.

To facilitate the smooth and proper flow of a research project in the GCRC certain procedures must be followed. Time must be allotted for education of nursing, nutrition and lab staff on the unique requirements of the study.

After a protocol has received CCI approval, a GCRC nurse will be assigned to the study as Study Coordinator. Each CRC nurse is responsible for approximately 10-15 studies. 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 GCRC 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 in the GCRC 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 GCRC 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 GCRC.

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 will be asked to hld an in-service meeting on the GCRC to explain the protocol in detail to the available nursing staff. This presentation will be videotaped so that all GCRC 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 GCRC 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 IRB 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 Ms. Mary Williams, RN, MS, Nurse Manager (667-3354).

Please note that you should book your appointments as far in advance as possible, in order to assure that you will get the preferred study dates. Subjects who have psychiatric conditions which preclude compliance to protocols, or low hematocrits for protocols that include blood drawing should be excluded from participation. Inclusion and exclusion requirements of each protocol will be monitored by nursing and nutrition personnel to assure the highest quality and safety of the study.

1. A pre-admission form, obtained from Ms. Noemi Osorio, Unit Coordinator, (667- 3351), and must be completed for each subject and sent to the GCRC no later than one (1) week prior to the admission date.

2. Protocol requirements should be reviewed with the subject by the investigator before admission.

3. Review of any costs for the subject (what is covered by the grant and what is not) is encouraged before admission.

4. Physician orders (signed by an MD with admitting privileges at Beth Israel Deaconess Medical Center who is an investigator on the protocol), must be at the GCRC before the subject is admitted.

5. Review of each subject’s special dietary needs with a GCRC research dietitian is recommended. Please contact Ms. Courtney Larson, RD, Chief Bionutritionist (667-3568) regarding this review process.

6. Schedule specifics of the subject visit (arrival time, etc.) with Ms. Noemi Osorio, Unit Coordinator (667-3351).

7. The properly signed consent form (i.e., in the presence of a witness) must be placed in the medical record upon admission of the subject. The subject must be given a copy of the signed consent form. No study activity will be carried out until after the consent has been signed. It is the investigator’s responsibility to obtain informed consent from the subjects.

8. Admission note for the medical record, which includes the patient’s medical history and physical exam must be completed within 24 hours of subject admission.

9. Daily progress notes in the medical record are necessary.

10. A completed summary on discharge signed by the Principal Investigator or the designated physician in charge is necessary when the subject leaves the GCRC. The medical records of the GCRC are governed by the standards established by the Joint Commission on the Accreditation of Hospitals Organization (JCAHO).

Subjects who have psychiatric conditions which preclude compliance to procols, or low hematocrits for protocols that include blood drawing should be excluded from participation. Inclusion and exclusion requirements of each protocol will be monitored by nursing and nutrition personnel to assure the highest quality and safety of the study.

1. Book your outpatient appointments as far in advance as possible with the Unit Coordinator, Ms. Noemi Osorio (667-3351).

2. Complete the outpatient physician order form.

3. A review of a subject’s special dietary needs with a GCRC Bionutritionist is recommended. Please contact Ms. Courtney Larson, RD, Chief Bionutritionist (667-3586) regarding this review process.

4. A signed consent form (signed in the presence of a witness) must be given to either the Unit Coordinator or study nurse.

5. A copy of signed and witnessed informed consent form must be given to subject.

6. Outpatient visits to the GCRC must be documented with an appropriate note in the patient’s hospital medical record. If the patient is not seen by GCRC nursing staff, it is the investigator’s responsibility to assure that the documentation is complete.

Each investigator is responsible for the care of subjects/patients admitted under his/her protocol, either personally or through designated co-investigators, fellows, or residents. Arrangements must be made for night and emergency coverage and for when the investigator is away from the Hospital. Phone numbers where these designated physicians can be reached must be written on the order form.

When the subject has an intercurrent illness that is unrelated to the research but is anticipated to be of a short duration, the subject may be kept under treatment at the Center. If the intercurrent illness requires termination of the study or its interruption for a considerable time, other arrangements for the subject’s care must be made.

                                                                                                                  Glossary