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New Study Start-Up
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| Clinical Trial Process Summary (Preview
Flow Chart) |
For any questions regarding new study start-up, please contact Heather Marban at (617) 667-4443.
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| Submission of CTO Required Documents
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The CTO reviews and negotiates clinical study
agreements and budgets for all industry-sponsored clinical
trials conducted at BIDMC. Principal Investigators are not
authorized to sign these agreements; they must be signed by an
official of the institution. In many cases, however, Principal
Investigators may sign the clinical study agreement as well to
indicate that they have read and acknowledged the duties and
obligations under the agreement. |
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| Before the CTO can review
your proposed study agreement, budget, and payment schedule,
you will need to return one or more of the following documents, as
applicable, to our Administrative Coordinator and to your
department Research Administrator. You will need a valid BIDMC
username and password to access the forms at our website.
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Notice:
BIDMC requires the CTO to review and approve all
industry-funded budgets and contracts before the IRB activates a
protocol. For clinical trials with non-industry funding, the CTO must review the budget for billing compliance in conjunction
with the
Office of Sponsored Programs.
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The Clinical Trials Office has a
dedicated email address to help answer your
questions at
cto@bidmc.harvard.edu.
Please return the completed forms to Ms. Heather Marban by email at
hmarban@bidmc.harvard.edu
or by fax (617-667-4446) along with a copy to
your Research Administrator. |
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PI Questionnaire for Industry-Funded
Studies (Preview
form) |
| The CTO uses
this form to collect information necessary to initiate
contractual and financial negotiations with industry sponsors.
You will also need to disclose any potential conflicts of
interest you might have with an industry sponsor. If the CTO
identifies a potential conflict, someone from our staff will
contact you to determine the best way to manage, reduce, or
eliminate the conflict in accordance with institutional codes of
conduct and other policies. This is an important and necessary
step before we engage an industry sponsor in the contracting and
budgeting process. |
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PI Questionnaire for Non-Industry Funded Studies
(Preview form) |
| The CTO
uses this form to collect information that is necessary to perform cost
analyses and is specific-to-direct patient care for all studies
funded by the federal government and non-profit organizations
and foundations. While federal and non-profit contracts are
managed by the
Office of Sponsored
Programs (OSP), the CTO
is responsible for ensuring that direct patient care costs are
budgeted appropriately for your proposed study. |
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Investigational New
Drug (IND) Exemption Checklist
(Preview form) |
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The
U.S.Food and Drug Administration
(FDA) requires the submission of an
Investigational New Drug Application
(IND) for all clinical studies involving "off-label" and
investigational use of marketed drug or biological product
unless deemed exempt by meeting specific criteria. Click
here for the list of six conditions that you will need to meet
in order to be considered exempt from IND submission and review. Click
here for the FDA IND Review
Process flow chart. |
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It is also important to note that the
Center for Drug Evaluation and Research
(CDER)
offers a Pre-Investigational New Drug Application (IND)
Consultation Program to foster early communications between sponsors and
new drug review divisions in order to provide guidance on the data
necessary to warrant IND submission. The review divisions are organized
generally along therapeutic class and can each be contacted using the
designated
Pre-IND Consultation List. |
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Investigational Device
Reimbursement Checklist
(Preview form) |
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Certain investigational
devices used in the context of a clinical trial may be eligible for
reimbursement under FDA and Medicare regulations and guidelines. To
request reimbursement for the investigational device and associated
services, whether the device is under
Investigational Device Exemption (IDE),
Premarket Approval (PMA),
Premarket Notification (510K), or
Humanitarian Device Exemption (HDE),
the CTO will petition Medicare for physician and hospital services
(coverage for Part A and Part B). |
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The Investigational
Device Exemption (IDE) regulations describe two types of device studies,
Significant Risk and Non-Significant Risk. The
designation of the investigational device to one of these risk
categories is very important to research sponsors and investigators.
All Significant Risk devices are governed by IDE regulations. If an
investigator is uncertain on the risk categorization, the IRB can assist
in this process through the review of an IRB application. |
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important to note that the
Center for Devices and Radiological Health
(CDRH) offers advice on IDE Regulations and
encourages sponsors and investigators to
contact the CDRH to obtain further
guidance through the Pre-IDE process. |
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| CTO Review Process (under construction) |
| Active Clinical Trial Financial
Management (under construction) |
| Audit Review and Study Close-Out
Process (under construction) |
