Investigator Manual
VII.
Investigator Responsibilities
It is the responsibility of the investigator to work with
the staff of the CRC 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 CRC certain
procedures must be followed. Time must be allotted for education of nursing,
nutrition and lab staff on the unique requirements of the study.
CRC Investigator Responsibilities and Requirements for CRC
Outpatient Visits and Inpatient Admissions
Before a research study begins in the CRC
Prior to study initiation in the CRC, the study
team and primary investigator meet with the CRC protocol coordinator nurse who has been selected to work up the study. As part of
this process, the CRC nurse will develop a set of flow sheets allowing all CRC clinical research nurses to implement the study in
the same manner, ensuring data collection is consistent. The primary investigator is responsible for reviewing and approving the
flow sheets before the subject visits begin.
The CRC nurse may also assist the study team in
developing standard orders for study visits to the CRC, and will also help develop sample processing guidelines for the research
samples collected during the CRC visits. An added benefit of this process is the review of the protocol by an experienced research
nurse will help resolve potential issues affecting implementation. In some cases, the study staff may be asked to in-service the
CRC staff on aspects of the study. These in-service classes will be filmed for viewing by all CRC staff.
Before a study can begin scheduling participants
in the CRC, the study team must check with the protocol coordinator nurse if things are ready to go.
Obtaining a medical record number:
All participants who are seen in the CRC must
have been registered for a BIDMC medical record number. This is essential for billing and is a requirement of BIDMC for all
patients. It is preferable for the participant to call Registration and register for a medical record number over the phone
(617-667-4929). However, if this is not possible, it is the responsibility of the research study team to complete a registration
form (http://research.bidmc.harvard.edu/GCRC/Forms.asp ),
and fax it to admitting. If the registration form is incomplete, the research team will be contacted by admitting to complete the
required information before a medical record number is given. If the participant is unsure if he/she already has a medical record
number, please call Registration or check in the online medical record system to verify.
Admitting a patient to the CRC:
When scheduling an inpatient
admission, a preadmission form must be completed by a member of the study team and faxed to the CRC (617-667-1525) before the
admission. If the participant has not been to BIDMC before, a medical record number is obtained for the participant at this time. It
is the responsibility of the research study team to make sure a medical record number has been issued and to complete the
preadmission form (http://research.bidmc.harvard.edu/GCRC/Forms.asp).
If the form is incomplete, the research team will be contacted by admitting to complete the required information before an
admission approval is given.
Scheduling a participant in the CRC:
Once a medical record number is obtained, the
research team may call the CRC to schedule a date for the appointment or admission. Scheduling is done Monday to Friday 8:00 AM to
3:30 PM. To schedule call: 617-667-3351.
Scheduling in the CRC is done based on
requirements for space, equipment and nursing time for each study visit. We keep two goals in mind; maintaining safe nursing/patient
ratios and maintaining quality data collection. Depending on the requirements of the visit you are scheduling it may be a longer
time until we can get your patient booked. It is suggested that you schedule in advance and if the protocol requires sequential
visits that you book them as a sequence, ahead of time.
Since the CRC is a shared resource for all
investigators at BIDMC, we ask in the event of a change in plans or a cancellation that you notify us as soon as possible. This will
allow us to rebook the time for another investigator. If you have been trying to schedule a specific date and it was unavailable
please keep checking back with us. If there is a cancellation we will fill the opening on a first come first serve basis.
Provision for medical care of BIDMC CRC subjects:
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 medical center.Contact information for designated physicians must be included in the admission orders. All responsible MD’s must be licensed in Massachusetts and credentialed at BIDMC.
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 CRC. 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. At times, this may
include transfer of the patient into the clinical care portion of the main
hospital.
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The
Harvard-Thorndike CRC is funded by Grant M01 RR01032 from the NCRR, NIH
Please send general questions about
the CRC to the
Administrative Manager.
Technical questions about this Web site can be addressed to the GCRC's
Webmaster.
Clinical Research Center
(CRC)
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
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