Investigator Manual
VIII Requirements for all CRC study visits, both outpatient and inpatient:
Only staff having a valid BIDMC ID may have ANY patient contact. ID badges
must be worn at all times. This is a hospital wide policy and ensures patients are not exposed to persons who have not been screened
by employee health services. All staff must identify themselves at the CRC front desk on arrival to the unit.
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 of the study and
safety of the subjects. It is essential that any amendments to the protocol are shared with the CRC protocol coordinator nurse, as
soon as they have been approved by the IRB. This allows the CRC nurses to update the flow sheets and standing orders to comply with
the protocol.
No study activity will be carried out until after informed consent has been
obtained and the consent form has been signed. It is the investigator’s responsibility to obtain informed consent. If the subject’s
primary language is not English, verbal interpretation of the consent into the subject’s native language
should be made through BIDMC Interpreter Services, to be arranged for by the investigator. None of the subject’s family
members may serve as translator. The subject and the CRC nurse must be given a copy of the signed consent form, and a copy must be
filed in the subject’s medical record.
Requirements for Outpatient Visits:
·
Outpatient appointments should be booked as far in advance as possible with the CRC Unit Coordinator
(617-667-3351).
- Outpatient physician orders are required.
- Standard, signed and copied orders per protocol
are acceptable for shorter outpatient visits, if approved by the CRC nurse study coordinator.
- For longer outpatient visits and those requiring
medication administration, the “inpatient” physician order form must be completed and signed including medication orders.
·
If applicable, a review of a subject’s special dietary needs with the CRC Bionutritionist is
recommended. Please contact the Chief Bionutritionist at 617-667- 3586.
·
A copy of the signed consent form must be given to either the Unit Coordinator or the CRC nurse on
the initial study visit. CRC nursing staff are available to serve as witness to the consent process and will document in their OMR
note for the initial visit that consent was obtained.
·
Outpatient visits to the CRC must be documented with an appropriate note in the patient’s hospital
medical record (OMR) and a census sheet. If the patient is not seen by CRC nursing staff, it is the investigator’s responsibility
to assure that the documentation is complete.
·
The physician may obtain access to CCC and the OMR for the purpose of documentation. Any research
testing which indicates a medical issue requiring follow up may be included in this documentation at the discretion of the physician
after discussion with the patient.
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The
Harvard-Thorndike CRC is funded by Grant M01 RR01032 from the NCRR, NIH
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