OSR-CT Instructions

Go to print-friendly page.

Investigator Information

Principal Investigator: A Principal Investigator on an industry sponsored clinical trial must be a faculty member and an M.D.

School/Center, Department/Center, Section/Program: To more accurately track project activity, provide all relevant information.

Project Location: Indicate the buildings and rooms of the project activity (e.g., 680 N. Lakeshore, Northwestern Center for Clinical Research). If more than one study site is anticipated, please indicate multiple locations.

Internal Contact Person: Identify the person who will be OSR's point of contact during the negotiation process, if contact person is other than the PI.

Individual to Receive Fully Executed Agreement: OSR will provide one copy of the fully executed agreement to the PI and upon request, to one additional individual. It is the responsibility of the individual receiving the contract to make sure that all parties involved in the study are aware of and agree to abide by the agreement terms and conditions.

Project Information

Study Title: Fill in as much of the study title as possible in the space provided. OSR will input the full title into the OSR database.

Sponsor: Name of the agency/organization providing support for the study.

Subcontract From/Contract Research Organization (CRO)/Site Management Organization (SMO): Name of the agency or organization receiving support from the sponsor and providing some of that support to Northwestern for its participation in the study.

Sponsor/CRO/SMO Contact: Name of sponsor/CRO/SMO contact who is authorized to negotiate agreement terms and conditions; include information on how to contact this person.

Investigator Initiated: Protocol developed by NU PI or a PI at another institution as opposed to a protocol developed by the industry sponsor.

New Clinical Trial: Initial involvement in a particular study.

Supplement/Amendment: Examples include an increase in the amount of funding, number of subjects, and possibly an extension of time for this particular study.

Sponsor Protocol #: Normally an alpha-numeric identifier for the specific study.

Personnel Chart

List the PI and all other study personnel and their Social Security numbers. If some study personnel are not NU employees, indicate employer in the department/center section (i.e. NMH, NMFF, etc.). If non NU personnel will be participating in this study, a subcontract will have to be prepared.

It is the responsibility of the PI to ensure that no one involved in the study has been debarred by the Food and Drug Administration (FDA). A list of debarred individuals may be found at: http://www.fda.gov/ora/compliance_ref/debar/default.htm

Sponsor Study Budget

The Office of Clinical Research and Training (OCRT) is available to assist with budget preparation and patient recruitment. For more information regarding services provided by the OCRT, call 312/503-1500.

CUFS #: If this project is a continuation of or related to another clinical project with this sponsor, provide existing CUFS number.

Proposed Project Period: Anticipated beginning and end dates. If the end date is indefinite, check "open ended". (When an account is established in the financial system, the project period end date will automatically be extended twelve months beyond the designated end date in the agreement for projects with definite end dates. This is being done to facilitate the orderly completion of the study. Projects with indefinite end dates have open end dates in the financial system.)

Per Patient Allocation: Cumulative total of cost components that support patient-related tests, procedures, etc. - including personnel and supplies. Subcontracted personnel costs should also be factored into the per patient allocation and should include salaries and benefits at the employer's established rates plus the employer's facilities and administrative costs. All of these subcontractor costs should be included in the per patient allocation direct cost category and NU's facilities and administrative costs at 26% should be calculated against the total.

Max. # Patients: Maximum number of patients authorized for enrollment at Northwestern under this protocol.

Other Costs: Ancillary costs associated with the study but not included in the per patient allocation, such as advertising. Include associated facilities and administrative costs at 26% of the direct costs.

IRB Fee: Effective September 15, 2003, the IRB fee for new submissions increased from $1,800 to $2,000 and the fee for a periodic review increased from $400 to $500. These fees are charged to all clinical trials supported by commercial sponsors. In addition, the Feinberg School of Medicine requires that all industry-sponsored trials include a line item in the budget that reflects additional costs related to the preparatory work required prior to submission of a protocol to the IRB. As a result, a regulatory fee of $4,500 (representing the $2,000 IRB fee plus $2,500 for regulatory preparation) must be included with all industry-sponsored clinical trial budgets submitted to the Office of Sponsored Research, except for trials performed through the Robert H. Lurie Comprehensive Cancer Center. Those trials will continue to be subject to the Clinical Research Office's standard regulatory preparation fee. Facilities and administrative costs should not be assessed on this amount.More information is available at http://www.research.northwestern.edu/oprs/irb/irbFees/.

Total: Total of per patient allocation X maximum number of patients, plus other costs + the IRB and regulatory fees. This amount includes both direct and applicable F&A costs as outlined above.

Budget Worksheet

IRB Fee Information

Clinical trials sponsored by industry must pay a $2,000 initial and $500 annual fee for IRB protocol review. Initial trials also incur a $2,500 regulatory preparation fee. Because this fee reimburses the University for costs associated with conducting the IRB review, it applies whether or not a contract is executed and/or patients are enrolled. A clinical trial sponsored project account (trial account) will be established by OSR and charged for the fee following receipt of OSR-CT materials. Annual fees will be charged directly to the trial account. In the event the Sponsor does not reimburse the University for the IRB fee, the Principal Investigator and/or Department will be responsible for this amount. Investigators are responsible for including the IRB fee in their clinical trial budget.

Procedures for Setting up Accounts

Authorized Spending & Guarantee Account Information

Upon receipt of the completed OSR-CT form, the draft agreement and the sponsored budget, study protocol, and consent (which may be submitted in preliminary form), OSR will establish a CUFS account for the clinical trial. Once established, OPRS will debit the account for the IRB fee. The trial account will not be available for use by the PI, however, until OSR has the IRB approval letter, final protocol and approved consent form, sponsor approved budget and a fully executed contract in addition to the completed OSR-CT.

Departments must provide a backup account that guarantees initial spending after execution of the contract but in advance of the initial payment(s) being received from the sponsor. If at any time during the trial, costs exceed funds received from the sponsor, the guarantor is responsible for the cost overrun. Guarantee Account #: In order to ensure that all study-related costs are charged directly to the trial account, a guarantee account is required. Provide a departmental or designated account number with sufficient funds to cover the guarantee amount. Study expenses will not be charged to the guarantee account. Instead, a unique sponsored project account will be set up. Funds from the guarantee account will be used only if funds received from the sponsor are less than the costs incurred on the trial account.

Budgeting Procedures:

An internal University budget is no longer required. Instead, the following objects of expense will routinely be opened on all industry sponsored clinical trials.

0010 Faculty salaries
0080 Fringe benefits, academic
0100 Professional exempt salaries
0180 Fringe benefits, non academic
2900 Industry clinical direct cost budget
3475 Lab supplies
5120 Printing and duplicating
5150 Advertising
5340 Lab services
5350 Clinical Trial Office Services
5493 Space rental, internal (Northwestern Center for Clinical Research only)
5525 Shipping/mailing
5720 Hospital medical expenses
5725 Protocol Processing/Activation fee
6735 Patient recruitment (faculty/staff recruitment)
8660 Research subject fees
8661 IRB Fee
8710 Indirect costs

Initially, accounts will be set up in the financial system without an appropriation. When the first check is received, the "prespending" status will be removed from the account and an appropriation will be established, equal to the value of the check. The direct cost portion of the appropriation will be placed in object 2900 and the indirect cost portion in object 8710. As additional checks are received, objects 2900 and 8710 will be increased accordingly. The sum of the budgeted amount in these two objects should always equal the cumulative revenue received from the sponsor. Expenditures should be made against the appropriate spending objects. No expenditures should be charged to object 2900.

Additional objects to be opened on this account: If objects are needed other than those listed above, please identify the object numbers.

IRB Approval of Study Protocol and Informed Consent

The Office for the Protection of Research Subjects (OPRS) is charged with facilitating the work of the institutional oversight committees, one being the Institutional Review Board (IRB). The role of the IRB is to ensure that human subjects enrolled in research projects or clinical trials are protected against undue risk and have given informed consent to the research, as well as to ensure that research subjects' rights, privileges, and privacy are protected. Questions regarding the IRB process should be directed to OPRS at 312/503-9338.

IRB approval must be obtained prior to initiation of any research activity that involves human subjects unless declared exempt by OPRS. Completed and endorsed human subject review forms must be received by OPRS at least ten working days prior to an IRB meeting. The schedule for meetings is available on the OPRS website (http://www.research.northwestern.edu/oprs/) or by contacting OPRS at 312/503-9338. All review forms should be submitted directly to OPRS. Forms and instructions on their use are available from OPRS, located on the Chicago campus Abbott Hall 5th floor, 710 North Lake Shore Drive.

Commitments

Patent Policy (12/98): University inventors are urged to contact the Technology Transfer Program (TTP) as soon as a potentially patentable discovery is made to determine a strategy for the protection of intellectual property. In addition to the policy, the Guide to Intellectual Property is available from TTP. To discuss questions about intellectual property, call TTP at 847/491-3005.

1. Animal Use: All animal review forms (Master Protocol 101, 201, 301, 401 forms) should be submitted directly to the Office for the Protection of Research Subjects (OPRS). Completed and endorsed forms must be received by OPRS at least ten working days prior to an Animal Care and Use Committee (ACUC) meeting. The schedule for ACUC meetings is available by contacting OPRS at 312/503-9338, or on-line at the OPRS website. Forms are available at OPRS, located on the Chicago campus Abbott Hall 5^th floor, 710 North Lake Shore Drive.

2. Safety Documentation: A Safety Plan is required for all laboratories. Laboratories using human blood and other potentially infectious human materials must also have an Exposure Control Plan. Use of hazardous chemicals creates obligations under the Hazard Communication Program. Contact the Office of Research Safety (ORS) for appropriate forms and to discuss and resolve compliance issues. The Chicago office is located in Room B106, Ward Building, 303 East Chicago Avenue, phone 312/503-8300.

3. Recombinant DNA and Ionizing Radiation: Registration is required if recombinant DNA technology is utilized. Use of radioactive materials must be approved by the Radiation Safety Committee, and all radiation workers must register with the Office of Research Safety (ORS). For information on these matters, contact ORS at 312/503-8300.

4. McGaw Medical Center/Other Institutions: This information is required to ensure that appropriate inter-institutional guidelines, procedures, and policies are followed. If non-NU personnel are involved in the project, a subcontract will be required.

5. Subcontracts: There are budget implications when using non-NU personnel (including personnel from other affiliates of the McGaw Medical Center); see previous section on sponsored study budgets. If a portion of the study will be subcontracted to another organization, contact OSR at 312/503-7955 to discuss subcontracting needs.

6. NCCR - Indicate if the project will use facilities or staff of the Northwestern Center for Clinical Research.

7. Human Biological Samples: Please indicate whether the project will use blood, fluid, or tissue biopsy samples or other tangible material derived from these samples. It is also recommended that the investigator consult the IRB concerning appropriate language to use in the informed consent document relative to the ownership, use and disposition of these samples.

Signatures

Each school has policies regarding endorsement of the OSR internal routing forms. Check with your department chair and/or dean for the appropriate policies. Unless signature authority has been delegated in writing by a department chair to a section chief or other designee, a department chair's signature is required. For studies that include more than one department or school, each department's and school's policies apply. In general, center directors and deans require investigators' and chairs' signatures before they will sign. Read the certification statement carefully before signing. Individuals will be held accountable for the accuracy of these certifications.