Investigator Manual
VIII. Requirements
for Outpatient Visits:
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)
Outpatient appointments should be booked as far in advance as
possible with the Unit Coordinator, Diane Greer (667-3351).
2)
The outpatient physician order form should be completed.
3)
A review of a subject’s special dietary needs with a CRC
Bionutritionist is recommended. Please contact Jeanene Fogli, MD, RD, LDN,
Chief Bionutritionist (667-1254) regarding this review process.
4)
A properly executed signed consent form must be given to either
the Unit Coordinator or study nurse. CRC nursing staff are available to serve
as witness to the consent process.
5)
A copy of the signed and witnessed informed consent form must be
given to subject.
6)
Outpatient visits to the CRC must be documented with an
appropriate note in the patient’s hospital medical record (OMR). If the patient
is not seen by CRC nursing staff, it is the investigator’s responsibility to
assure that the documentation is complete.
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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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the CRC to the
Administrative Manager.
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Clinical Research Center
(CRC)
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