Investigator Manual
IV.
Protocol Submission
All protocols which utilize the CRC must be approved by both the Committee on Clinical Investigation (CCI), the Beth Israel Deaconess Medical Center Institutional Review Board and the
CRC Scientific Advisory Committee. All protocols requiring use of the CRC should include Part I of the CCI application. 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 CRC 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 and contracting (BR109 2nd floor 667-4282).
Investigators may submit proposals concurrently to the CCI and the SAC. 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). 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 CRC 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.
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The
Harvard-Thorndike CRC is funded by Grant M01 RR01032 from the NCRR, NIH
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