Investigator Manual
IV. Protocol Submission
All protocols which utilize the CRC must first be approved by the Committee on
Clinical Investigation (CCI), the Beth Israel Deaconess Medical Center
Institutional Review Board. The CCI office is located in Finard 2, East
Campus, 667-0476. The application and instructions are available on the
IRB web site:
http://www.research.bidmc.harvard.edu/ost/clinicaltrials/forms.asp
The Committee on Clinical Investigations reviews
the protocol primarily for ethical standards and risks and benefit to research
subjects, the informed consent form and procedure, the selection of subjects and
provisions for maintaining confidentiality of information on subjects and data.
The Scientific Advisory Committee primarily reviews the protocol
for scientific merit, study design and appropriate utilization of CRC
resources.
The CCI meets twice a month to review new protocols; meetings are held every other week. The schedules for application deadlines and meetings are also
available on the CCI’s web site. An integral part of the application is the
request for use of the Clinical Research Center (Section I). Other information
in the application is utilized by CRC staff to provide essential information
about the study.
If the study is funded or supported by industry, it
is important to work with the staff in the Research and Academic Affairs Office
who will assist with budgeting of clinical trial protocols (Finard 201
667-4282).
It is preferable that each protocol be approved by
the CCI before requesting approval for CRC use through the Scientific Advisory
Committee. Each protocol must be reviewed and signed by the administrative
personnel in the CRC. Thirty-five double-sided copies of the IRB application should be submitted to the
Administrative Office of the CRC (GZ-800). Please deliver the CRC
materials when you submit to the CCI. The CRC also requires four copies each
of the pharmaceutical company or multi-center protocol, grant application (if
applicable), and any questionnaires, forms, etc. being used.
Modifications to protocols: copies of
changes, modifications, amendments to the protocol which are submitted to CCI
must also be submitted to the CRC, along with copies of correspondence to and
from the Chair. This includes annual reviews and approvals, and the yearly
dated consent form with appropriate IRB approval stamp. In some cases,
modifications to protocols may require re-review by the Scientific Advisory
Committee.
Research subject classification:
Research protocols are classified for CRC purposes into one of three types:
"A"
- Pure research: studies initiated by the investigator. Usually
funded by the NIH or foundations, but may have support from industry;
"B" - Subjects who are hospitalized for a medical problem supported
by third-party payments but participating in a research study (medically
necessary admission);
"D" - Subjects involved in
industry-initiated studies.
In cases where the classification seems unclear, the Scientific Advisory
Committee will make the final determination. For those protocols that are
investigator-initiated with industry support, please contact the CRC
Administrative Office well in advance of submission to discuss the supporting
documentation needed by the CRC Scientific Advisory Committee.
Charges
for CRC use
For investigator-initiated studies ("A" patients),
the CRC will support the full cost of admission to the hospital or the use of
an outpatient "bed." Specifically, this means that there will be no charge for
bed use, nursing care, or nutritional support. The CRC may also support
laboratory work including routine chemistries and other more specialized tests
such as radioimmunoassays. Availability of funding for lab tests depends on
several factors. When outside funding exists for an “A” study, the CRC cannot
provide duplicate support. Please note that clear documentation of
investigator-initiated status for protocols with industry support is required
for the CRC files. Studies for which documentation does not exist will be
classified as “D”.
For "B" patients, the CRC may be able to support
the cost of testing which is not medically necessary, but, which is required strictly for
the research portion of the protocol. This is decided on a case-by-case
basis by the administrative staff and the Scientific Advisory Committee.
The CRC is required to charge a fee for all "D"
(industry-initiated) services. It is advantageous to meet with the
Administrative Manager before submitting the budget to the industry sponsor to
ensure that all necessary charges have been included. Since charges to industry
must be the same for all investigators throughout the institution, no reduction
of applicable charges can be made. In addition, all industry-initiated
protocols are assessed a one-time fee at study submission to cover CRC
administrative costs.
next page
The
Harvard-Thorndike Clinical Research Center is a Harvard Catalyst Research Unit
and is funded by Grant UL1 RR 025758 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 CRC's
Webmaster.
Clinical Research Center
(CRC)
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Copyright © 2008, Informatics Core. All rights reserved.
| 