Standard Orders (typewritten on UCLA Clinical Order Form) must contain an explicit outline of those aspects of the research which are to be carried out by the UCLA-GCRC nursing staff and are required for each inpatient/outpatient admission. To develop this most efficiently, investigators are encouraged to work with the delegated UCLA-GCRC nurse team assigned to the research project; Specific clinical procedures and schedules are best planned in collaboration with the nurses who are familiar with and experienced in the day-to-day implementation of research projects. After receiving approval from the GCRC Advisory Committee(GAC), the investigator must present the final research plan to the center staff and outline the nursing, dietary, laboratory and other support necessary for the conduct of the research before subjects can be scheduled for admission to the center.
It is the investigator's responsibility to procure special equipment not available from the UCLA-GCRC. The GCRC routinely provides the standard clinical supplies such as syringes, needles, IV solutions, IV tubing, blood tubes and other means of sample collection. The availability of pumps for infusing solutions, monitors, and special collection devices or recording equipment is the investigator's responsibility and should be checked with the clinical nurse manager before subjects are scheduled for admission.
Scheduling Subjects' Admissions
Investigators with approved projects should contact Administrative Assistant Sophie Ta at (310)825-5225 to request a room reservation between one and six weeks prior to the expected date of inpatient admission or outpatient visit in order to determine the specific admission date and time. The room reservation will then be confirmed by fax or telephone. Admission depends on the priority rating scored by the GCRC Advisory Committee and on the availability of beds, equipment and staff on the GCRC unit.
Admission requests are made by completing and sending a UCLA-GCRC Reservation Request Form and UCLA Medical Center pre-admission planning forms to Sophie Ta, the Administrative Assistant at (310)825-5225, 27-066 CHS. All patients must be admitted and registered by Ms. Sophie Ta in the GCRC. Investigators or their associates must communicate with all study participants, as unit staff are not equipped to handle telephone calls to study participants.
Provisions for Medical Care of UCLA-GCRC Participants
Patients admitted to the UCLA-GCRC are to receive optimal medical care. Each investigator is responsible for the care of patients admitted under his or her project, either personally or through designated co-investigators, fellows, or residents. Arrangements for emergency and night care must be formalized; house officer coverage is required. The director and associate directors are responsible for reviewing the medical status of all admissions to ensure high-quality patient care and the subjects' qualifications to participate in the research studies.
The principal investigator or an M.D. co- investigator is responsible for the medical care of all research participants and for the completion of the admission medical records. Delegation of these duties to other M.D. members of the investigative team is acceptable.
Occasionally a subject's admission may occur at a time when the principal investigator is not available or cannot be reached. For this reason, each investigator must list at least one additional responsible M.D. on the face sheet inside the subject's chart. Principal investigators also may provide the director with a list of M.D. research fellows responsible for their subjects. In the event that problems arise, the principal investigator and/or co-investigator will be called for consultation.
a. Intercurrent Illnesses In the event of an intercurrent illness, not a result of the research, the appropriate disposition of a participant in the UCLA-GCRC depends on the severity of the illness and its relationship to the research. The subject may be kept under treatment in the UCLA-GCRC when the illness is unrelated to the research but is anticipated to be of short duration. If the intercurrent illness requires termination of the study or its interruption for a substantial time, other arrangements for the participant's care should be made. b. Scatter Beds The cost of occasional, unexpected, temporary use of special facilities, such as an intensive care unit, may be charged to the UCLA-GCRC provided that the care is required by an illness resulting from the research; the care is provided in a specialized area (intensive care unit, coronary care unit, etc.); the subject remains on the UCLA-GCRC census (under the scatter bed classification) while in the special care unit; and there is no duplication of payment for care. If the use of special facilities such as an intensive care unit is to be an established part of a UCLA-GCRC research project and was not previously peer-reviewed, prior written approval is required from NIH.
a. Intercurrent Illnesses
In the event of an intercurrent illness, not a result of the research, the appropriate disposition of a participant in the UCLA-GCRC depends on the severity of the illness and its relationship to the research. The subject may be kept under treatment in the UCLA-GCRC when the illness is unrelated to the research but is anticipated to be of short duration. If the intercurrent illness requires termination of the study or its interruption for a substantial time, other arrangements for the participant's care should be made.
b. Scatter Beds
The cost of occasional, unexpected, temporary use of special facilities, such as an intensive care unit, may be charged to the UCLA-GCRC provided that the care is required by an illness resulting from the research; the care is provided in a specialized area (intensive care unit, coronary care unit, etc.); the subject remains on the UCLA-GCRC census (under the scatter bed classification) while in the special care unit; and there is no duplication of payment for care. If the use of special facilities such as an intensive care unit is to be an established part of a UCLA-GCRC research project and was not previously peer-reviewed, prior written approval is required from NIH.
Medical Requirements for UCLA-GCRC Admissions
a. General Requirements for Inpatient Admissions
- May leave UCLA-GCRC, but not the hospital, with consent of the principal investigator and director.
- May leave hospital with consent of the principal investigator and director.
b. General Requirements for Outpatients
Medical Records
The hospital medical record is to be kept in the same detail and with the same standards as that of any other patient admitted to the UCLA Medical Center. This means that subjects admitted directly to the UCLA-GCRC must have a full medical history and physical examination in the record, and that subjects transferred from other services to the UCLA-GCRC must have the appropriate transfer notes. Daily progress notes should include a description of the research procedures and their results, as well as the current data obtained on the subjects. These notes will enable the center personnel to follow the progress of the research project. Investigators keeping inadequate progress notes will be advised by the associate director.
The principal investigator or the designated physician-in-charge will be responsible for signing out the record when the subject leaves the center. The center medical records are governed by the standards established by the Joint Commission on the Accreditation of Hospitals Organization (JCAHO).
Institutional Review Board Approval and Informed Consent
a. Institutional Review Board Approval
It is the responsibility of the principal investigator to send an up-to-date Notice of Approval from the Human Subject Protection Committee to the GCRC administrative office for each active study. It is also the principal investigator's responsibility to check for the expiration of the consent.
b. Informed Consent
The original signed consent form must be on the subject's chart prior to each inpatient admission or outpatient visit and before commencement of any planned research. The investigator is also required to retain a signed copy and to give a copy to the study subject.
Hospitalization Costs
It is the responsibility of the principal investigator to explain to subjects the hospitalization costs of their participation in the study and the assumption of the responsibility for those costs by either the UCLA-GCRC, the investigator's own funds, third-party payers, or the individual study subject. It is the investigator's responsibility to make certain that participants understand that only the research costs for time spent on the UCLA-GCRC may be paid by the center, and that the UCLA-GCRC is not responsible for charges that apply for any other purpose or period of their hospitalization.
Training Resource
The training of health professionals in the methods of clinical investigation should be an integral part of the research effort on each project. Regular rotation on the center by research fellows, residents, and medical, nursing, pharmacy, and dietary students is encouraged. Since the UCLA-GCRC is expected to be a model of excellence in contemporary clinical research techniques, the center may also be used for other instructional purposes, including programs of continuing education for practicing physicians, nurses and dietitians.
Each trainee (student or post-doctoral fellow) participating in research on the center must have a qualified supervisor identified in center records. This supervisor, typically the principal investigator of the approved research project on which the trainee is working, is to be responsible for the medical and scientific quality of the work performed by the trainee.
Formal instruction in conduct of clinical research is available in the UCLA-GCRC.
Research Project Renewal and Progress Reports
An investigator may admit subjects under a given project the year beginning with its date of approval by the IRB and the GCRC Advisory Committee. Thereafter, projects will undergo an annual review by the GCRC Advisory Committee at the time of the UCLA-GCRC's annual report. (Projects approved within the last six months of the year do not require renewal at the end of that year.) Renewal depends on progress of the research as well as on scientific merit. If the research project has been altered, an amended project must be submitted. Projects will automatically be canceled if reports are not submitted by December 15th of each year. Investigators will be provided with guidelines for the preparation of annual progress reports no later than December 1st.
An annual report must be prepared by the UCLA- GCRC in accordance with instructions from NIH. Assimilation of the material necessary for this report is the responsibility of the director. The report is based on the annual progress reports and publications of investigators utilizing the center. Each investigator should keep records of his or her research activity to assist the UCLA- GCRC in the preparation of this report.