Investigator Manual
IX. Requirements for Inpatient Admissions to the CRC:
Inclusion and exclusion
requirements of each protocol must be adhered to and will be monitored by
nursing and nutrition personnel to assure the highest quality and safety of the
study.
1)
Admissions should be scheduled as far in advance as possible, in
order to assure that there is appropriate bed availability. Scheduling is done
with the Unit Coordinator, Diane Greer (667-3351).
2)
A pre-admission form, obtained from Diane Greer, Unit
Coordinator, (667- 3351), must be completed for each subject and sent to the CRC no later than one (1) week prior to the admission date.
3)
Protocol requirements should be reviewed with the subject by the
investigator before admission.
4)
Review of any costs for the subject (what is covered by research
funds and what is not) is encouraged before admission.
5)
Physician orders (signed by an MD with privileges at Beth Israel
Deaconess Medical Center who is an investigator on the protocol), must be at the
CRC before the subject is admitted.
6)
Review of each subject’s special dietary needs with a CRC
research dietitian is recommended. Please contact Jeanene Fogli, MS, RD, LDN,
Chief Bionutritionist (667-1254) regarding this review process.
7)
The properly signed and witnessed consent form 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 CRC. The medical records of the CRC are governed by the standards
established by the Joint Commission on the Accreditation of Hospitals
Organization (JCAHO) and the BIDMC medical staff by-laws.
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The
Harvard-Thorndike Clinical Research Center is a Harvard Catalyst Research Unit
and is funded by Grant UL1 RR 025758 from the NCRR, NIH
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Administrative Manager.
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Clinical Research Center
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